Archive for the ‘Molecular Genetics’ category

« Older Entries
Newer Entries »

Diagnocure 2012 first quarter results

March 31st, 2012

FDA Approval of The First Molecular Prostate Cancer Test and Decreased Net Loss

QUEBEC CITY, March 30, 2012 /PRNewswire/ – DiagnoCure Inc. (TSX: CUR.TO – News), a Quebec life sciences company that develops and commercializes high-value cancer diagnostic tests, today reported financial and operation results for the first quarter 2012 ended January31,2012. The Company announced a net loss from continuing operations of $816,164 or $0.02 per share for the first quarter ending January31, 2012, compared to a net loss of $998,439 or 0.02$ per share for the same quarter of 2011. At the end of the quarter, cash, short-term investments and long-term investments stood at $7,832,547. The cash position was impacted by the timing of payments.

First Quarter 2012 Highlights

First Quarter 2012 Results

The Company’ financial statements for the period ended January 31, 2012 have been prepared for the first time in accordance with IAS 34, Interim Financial Reporting, International Financial Reporting Standards (IFRS). Comparative unaudited consolidated condensed financial statements for 2011 have been adjusted to reflect the Company’s adoption of IFRS on a retrospective basis, effective November 1, 2010.

Total revenues for the first quarter of 2012 were $556,158 compared with $292,878 for the same period of 2011. In the first quarter of 2012, royalty revenues amounted to $163,791 compared with $161,790 for the corresponding period of 2011. Royalty revenues from Gen-Probe decreased by $16,067 to $145,012 for the first quarter of 2012, from $161,079 for the same period of 2011. Royalty revenues from Scimedx, related to ImmunoCytTM/uCyt+TM, increased by $7,906 to $8,617 for the first quarter of 2012, from $711 for the same period of 2011. Following the agreement signed with Signal Genetics, DiagnoCure recorded PrevistageGCC royalties of $10,162 in the first quarter of 2012. Also, in the first quarter of 2012, DiagnoCure provided Signal Genetics R&D services in support to the PrevistageGCC Colorectal Cancer Staging Test for an amount of $268,567. Pursuant to the amendment agreement signed with Gen-Probe on April 29, 2009, DiagnoCure recorded a portion of the annual payment, that is, $123,800 for the first quarter of 2012, compared with $131,088 for the same period of 2011.

Operating expenses before stock based compensation and amortization increased by $220,506, to $1,081,923 for the first quarter of 2012 from $861,417 for the first quarter of 2011. This increase is mainly attributable to the R&D services performed in support to the PrevistageGCC Colorectal Cancer Staging Test for which revenues of $268,567 were booked as stated above. Total operating expenses increased primarily as a result of the following:

Based on the above, for the first quarter of 2012, DiagnoCure recorded a net loss from continuing operation of $816,164 or $0.02 per share, compared with $998,439 or $0.02 per share, for the same period of 2011.

Conference call with investors

Investors and financial analysts wishing to participate in the “DiagnoCure Q1 2012 Earnings Announcement” conference call to be hold today, March 30, 2012 at 11:30 a.m. (EST) shall dial the toll-free number 1-888-231-8191, and provide the conference ID number: 61577555.

See the article here:
Diagnocure 2012 first quarter results

Comments Off »

Posted in Molecular Genetics

Tags:

Lineagen Presents Data Showing Clinical Utilization of FirstStepDx®, a New Model of Genetic Service Delivery, at the …

March 29th, 2012

CHARLOTTE, N.C., March 29, 2012 /PRNewswire/ — Lineagen, Inc., an innovative molecular diagnostics company focused on complex, genetically linked disorders, today presented clinical utilization data for Lineagen’s FirstStepDx. FirstStepDx is a comprehensive evaluation service that integrates highly advanced and comprehensive genetic testing for individuals with developmental delay (DD), intellectual disability (ID), and autism spectrum disorders (ASD) with personalized pre- and post-testing genetic counseling and industry leading reporting services.

(Logo: http://photos.prnewswire.com/prnh/20111214/NY22073LOGO )

In a poster presentation titled, “Genetic Services for Individuals With Autism Spectrum Disorder in Primary Care,” Lineagen reported FirstStepDx clinical utilization data according to physician subspecialty, test outcomes and use of genetic counseling services. The data shows that a broad range of pediatric specialties are ordering Lineagen’s FirstStepDx genetic test. In addition, of the first 940 patients and families who utilized the FirstStepDx test, over two-thirds of patients used the genetic counseling services offered through Lineagen as part of FirstStepDx integrated service package.

These and other data on FirstStepDx were presented at the 2012 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting being held in Charlotte, North Carolina.

Michael S. Paul, Ph.D., President and CEO of Lineagen, commented, “We are pleased to present this initial data that demonstrates growing adoption, utilization, and integration of FirstStepDx into clinical practice. By providing a new method of delivering genetic services, we believe we can help transform diagnostic evaluation of individuals with DD, ID, and ASD, with the potential to significantly influence timely clinical management and targeted initiation of appropriate care.”

Andy Peiffer, M.D., Ph.D., Assistant Professor at the University of Utah and Lineagen’s Director of Pediatric Genetics, stated, “FirstStepDx offers more information to aid clinicians in understanding the genetic etiology associated with a patient’s developmental delay-related condition. In many cases, this information can be critical in providing a more complete view to clinical management and intervention. This information also is reflected in the extensive reporting offered through FirstStepDx to families, who can benefit greatly from gaining a more holistic perspective on the underlying condition that is being evaluated and treated.”

About FirstStepDx

Lineagen’s FirstStepDx service and related autism-risk screening services (www.m-chat.org) have been developed with the specific intention of helping physicians, patients, and families navigate the “odyssey” of diagnosing and evaluating children with a clinical diagnosis of developmental delay, intellectual disability, and autism spectrum disorders (ASD) more efficiently. FirstStepDx includes personal genetic counseling, the most advanced chromosomal microarray clinically available, fragile X genetic testing, analysis by medical experts, and a detailed, personalized report created specifically for each individual’s case. FirstStepDx is specifically designed to help parents and physicians significantly shorten the time to clinical action, allowing access to proven clinical management and appropriate care as early as possible.

The FirstStepDx genetic test now is available as a fast and painless cheek swab (FirstStepDx Buccal), eliminating the need for a blood draw. For more information about FirstStepDx, please call Lineagen at 888-888-OPEN (888-888-6736) or visit www.FirstStepDx.com.

About Lineagen

Go here to see the original:
Lineagen Presents Data Showing Clinical Utilization of FirstStepDx®, a New Model of Genetic Service Delivery, at the …

Comments Off »

Posted in Molecular Genetics

Tags:

Myriad Genetics Enters Testing Agreement With Teva Subsidiary

March 29th, 2012

DOW JONES NEWSWIRES

Molecular-diagnostic company Myriad Genetics Inc. (MYGN) said Wednesday it agreed to conduct BRCA1 and BRCA2 mutation testing for Cephalon Inc., a Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) subsidiary, to help assess women’s risk for hereditary breast and ovarian cancer.

BRCA1 and BRCA2 are human genes that belong to a class of tumor suppressor genes. Mutation of these genes has been linked to hereditary breast and ovarian cancer, according to the National Cancer Institute.

Under the agreement, Myriad will assess the BRCA status in patients prior to being enrolled in a Phase I/II study. Myriad has entered into similar agreements with Abbott Laboratories (ABT), AstraZeneca PLC (AZN, AZN.LN) and BioMarin Pharmaceutical Inc. (BMRN) to provide companion diagnostic testing for clinical trial enrollment.

Myriad’s shares closed Wednesday at $23.56 and were inactive after hours. The stock is up 15% over the past three months.

-By Ben Fox Rubin, Dow Jones Newswires; 212-416-3108; ben.rubin@dowjones.com

Follow this link:
Myriad Genetics Enters Testing Agreement With Teva Subsidiary

Comments Off »

Posted in Molecular Genetics

Tags:

AMP Optimistic in Suit to invalidate Patents on Breast Cancer Genes

March 28th, 2012

Newswise Bethesda, MD, March 27, 2012: Now that the Supreme Court has remanded Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al. (AMP v. Myriad) to the Court of Appeals for the Federal Circuit for further consideration, AMP is optimistic that it will ultimately prevail in its lawsuit to invalidate patents on two genes that are known to cause breast cancer.

Our members have witnessed the adverse effects of gene patents on patient care, stated Iris Schrijver, AMP President. By awarding monopolies in testing of patented genes, these patents reduce patient access to genetic tests, increase test prices, and stand in the way of innovations in diagnostic methods. Further, Dr. Schrijver added, Because variation in gene sequences plays an important role in the development and progression of many diseases, through gene patents patent holders can essentially gain ownership of the understanding of some diseases and of certain areas of patient care itself.

Stated Roger D. Klein, MD, JD, Chair of the AMP Professional Relations Committee: We were extremely encouraged by the Supreme Courts reaffirmation in its Prometheus decision of the longstanding principle that natural phenomena are not patent eligible. In Prometheus, the Supreme Court clearly ruled that the correlation between a biomarker and a clinical phenotype cannot be patented. Similarly, in light of this decision we expect that the Court of Appeals for the Federal Circuit will ultimately find that patents on natural products, in this case BRCA1 and BRCA2, cannot be used to exclude physicians and others from examining their patients genes for disease-related variants.

In its original decision, the Appeals Court held that human gene sequences are patentable subject matter when separated from their native state within cells. This is really a form versus substance argument, said Mary Williams, AMP Executive Director. A disease-causing mutation means the same thing for the patient irrespective of whether a gene is examined inside or outside the patients body.

AMP is looking forward to the proceedings in the lower court. We are confident that optimal patient care and sound science will ultimately prevail, stated Williams.

ABOUT AMP: The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit www.amp.org.

Read more:
AMP Optimistic in Suit to invalidate Patents on Breast Cancer Genes

Comments Off »

Posted in Molecular Genetics

Tags:

Disorders of Hemoglobin: Genetics, Pathophysiology, and Clinical Management [Book and Media Reviews]

March 28th, 2012

Edited by Martin H. Steinberg, Bernard G. Forget, Douglas R. Higgs, and David J. Weatherall 2nd ed, 846 pp, $399 Cambridge, United Kingdom, Cambridge University Press, 2009 ISBN-13: 978-0-521-87519-6

Few textbooks are devoted to a single molecule. Yet hemoglobin is a spectacular molecule, without which life would not be possible. The history of hemoglobin dates to 1840, when Friedrich Hnefeld and others discovered that hemoglobin carries oxygen. Approximately 100 years later, Max Perutz discovered the molecular structure of hemoglobin by x-ray crystallography and was awarded the Nobel Prize for this work. The entire genomic structure of hemoglobin is now known, allowing for vast new amounts of information about its role in health and disease.

There are hundreds of different hemoglobins; some are specific for embryonic, fetal, and adult life, and others are variants. Some variants, such as hemoglobin S, have conferred protection for whole populations against malaria and other infectious diseases by trapping parasites within their membranes, allowing the parasites to be cleared in the reticuloendothelial system. Two prototypical abnormalities of hemoglobin account for most diseases: qualitative defects in

Read the original:
Disorders of Hemoglobin: Genetics, Pathophysiology, and Clinical Management [Book and Media Reviews]

Comments Off »

Posted in Molecular Genetics

Tags:

Natera Announces Presentations During the American College of Medical Genetics 2012 Annual Clinical Genetics Meeting

March 28th, 2012

Natera, formerly known as Gene Security Network, today announced that data from studies of the company’s bioinformatics Parental Support technology will be presented during the American College of Medical Genetics 2012 Annual Clinical Genetics Meeting at the Charlotte Convention Center in Charlotte, North Carolina.

See the rest here:
Natera Announces Presentations During the American College of Medical Genetics 2012 Annual Clinical Genetics Meeting

Comments Off »

Posted in Molecular Genetics

Tags:

Ambry Genetics Introduces "First-Step Exome™" Sequencing Test

March 27th, 2012

Ambry Genetics, a global leader in genetic services with a focus on clinical diagnostics and genomics, announces the First-Step Exome™ test. The First-Step Exome reports on all Human Gene Mutation Database (HGMD)-defined genes.

Visit link:
Ambry Genetics Introduces "First-Step Exome™" Sequencing Test

Comments Off »

Posted in Molecular Genetics

Tags:

Ariosa Diagnostics Announces Completion of Laboratory-Developed Test Study for the Harmony™ Prenatal Test

March 27th, 2012

SAN JOSE, Calif., March 26, 2012 /PRNewswire/ — Ariosa Diagnostics (formerly Aria Diagnostics), a molecular diagnostics company, today announced the completion of its clinical validation study for the Harmony Prenatal Test. The multi-national study represents the largest clinical study performed to date for non-invasive prenatal detection of common fetal trisomies. The test utilizes a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood. Additionally, information about the company’s proprietary biochemistry and algorithm platforms, which work together to efficiently analyze patient samples in order to provide individualized risk scores, will be presented at the 2012 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting in Charlotte, N.C.

(Logo: http://photos.prnewswire.com/prnh/20120326/NY75864LOGO )

“The completion of our validation study is an important milestone as we prepare to bring the Harmony Prenatal Test to market,” said Ken Song, MD, chief executive officer at Ariosa Diagnostics. “The Harmony Prenatal Test’s performance is the largest study to date using cell-free DNA technology and supports findings from our previous studies recently published in the American Journal of Obstetrics and Gynecology and Prenatal Diagnosis demonstrating highly accurate fetal trisomy detection.”

At the upcoming ACMG meeting, additional data on Ariosa’s technology will be shared during an oral platform presentation (Molecular session) titled, “Non-Invasive Fetal Aneuploidy Detection in Cell-free DNA from Maternal Blood Using Digital Analysis of Selected Regions (DANSR) and the Fetal-fraction Optimized Risk of Trisomy Evaluation (FORTE) Algorithm” on Thursday, March 29, 2012 from 8:30 to 8:45 a.m. at the Charlotte Convention Center.

Formerly known as Aria Diagnostics, the company has changed its name to Ariosa Diagnostics in an effort to further distinguish and differentiate itself from other companies and products.

About Ariosa Diagnostics (formerly Aria Diagnostics)

Ariosa Diagnostics, Inc., is a molecular diagnostics company committed to providing safe, highly accurate and affordable prenatal tests for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. Ariosa’s simple blood test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company began operations in 2010 and is headquartered in San Jose, Calif. For more information, visitwww.ariosadx.com.

Continued here:
Ariosa Diagnostics Announces Completion of Laboratory-Developed Test Study for the Harmony™ Prenatal Test

Comments Off »

Posted in Molecular Genetics

Tags:

March 26, 2012

March 27th, 2012

March 11, 2012 Third-year microbiology, immunology, and molecular genetics student Jeffrey Lin and second-year computer science and engineering student Kirby Cool are two seekers on the UCLA Quidditch team. After a winning match, they discuss their strategies and experiences in catching the golden snitch.

Check out more coverage of the UCLA Quidditch Western Cup III here.

[2:09]

View original post here:
March 26, 2012

Comments Off »

Posted in Molecular Genetics

Tags:

Horizon Diagnostics, EMQN Ink Deal for Cell Line Reference Standards

March 27th, 2012

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Horizon Diagnostics will provide genetically defined human cell line reference standards for distribution to molecular diagnostic laboratories worldwide under a deal with the European Molecular Genetics Quality Network (EMQN) announced today.

The cell line references will be distributed as part of EMQN’s annual external quality assessment schemes to ensure sensitivity and reproducibility of diagnostic assays.

Horizon Diagnostics, a division of Horizon Discovery, will provide materials that contain known frequencies of mutations that currently guide the prescription of oncology therapies, particularly for melanoma, colon cancer, and lung cancer. Horizon will distribute the materials to participants of EMQN’s proficiency testing schemes.

“Quality assurance schemes such as those organized by EMQN are essential to ensure that patients receive the correct treatment regimen based on their tumor mutation status,” Paul Morrill, commercial director for Horizon Discovery, said in a statement. “Horizons technology offers pathologists and biologists an unprecedented level of control, and a resource for benchmarking the performance of assays against validated empirical reference standards. This is an invaluable component of patient care.”

Financial and other terms of the deal were not disclosed.

Go here to read the rest:
Horizon Diagnostics, EMQN Ink Deal for Cell Line Reference Standards

Comments Off »

Posted in Molecular Genetics

Tags:

Myriad Genetics Says Supreme Court Of United States Remands Gene Patenting Case

March 27th, 2012

(RTTNews.com) – Myriad Genetics Inc. (MYGN) announced that the Supreme Court of the United States remanded the case of The Association for Molecular Pathology, et al., v. Myriad Genetics Inc., et al to the Federal Circuit Court of Appeals.

The company said that as a result of this decision by the Supreme Court, the United States Court of Appeals for the Federal Circuit will reconsider their decision dated July 29, 2011, which upheld Myriad’s gene patents.

In that decision, the Federal Circuit declared that the composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible under Section 101 of the United States Patent Act.

“While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection,” said Peter Meldrum, President and CEO of Myriad Genetics.

“Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful,” said Peter Meldrum.

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com

Originally posted here:
Myriad Genetics Says Supreme Court Of United States Remands Gene Patenting Case

Comments Off »

Posted in Molecular Genetics

Tags:

Supreme Court of the United States Remands Gene Patenting Case

March 27th, 2012

SALT LAKE CITY, March 26, 2012 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (Nasdaq:MYGN – News) reported today that the Supreme Court of the United States remanded the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al (Docket No. 11-725) to the Federal Circuit Court of Appeals. As a result of this decision by the Supreme Court, the United States Court of Appeals for the Federal Circuit will reconsider their decision dated July 29, 2011, which upheld Myriad’s gene patents. In that decision, the Federal Circuit declared that the composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible under Section 101 of the United States Patent Act.

“While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection,” said Peter Meldrum, President and CEO of Myriad Genetics. “Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful.”

Importantly, Myriad’s intellectual property for the BRACAnalysis(R) test is strong with 23 issued patents and approximately 500 claims, including approximately 245 composition of matter claims and 240 method claims. Only 15 claims are at issue in this case; the rest of the claims remain in full force and effect providing Myriad with extensive patent protection.

Myriad is committed to researching and commercializing innovative molecular diagnostics tests, such as the BRACAnalysis test, to assess a person’s risk of developing disease, guide treatment decisions and help improve patients’ quality of life. As such, the Company plans to continue its strong commitment to promoting women’s health in the areas of hereditary breast and ovarian cancer, advancing and fostering research on the BRCA genes, and providing excellent patient access to its test, including offering financial assistance programs to qualifying individuals.

It is important to correct some common misconceptions on the societal impact of “gene” patents; namely that such patents impede research, result in high-cost testing and takeaway a patient’s option for confirmatory testing. Myriad believes that statements made to these points in the public press are incorrect. To set the record straight,

Brian M. Poissant, Gregory A. Castanias, Laura A. Coruzzi, Eileen Falvey and Sasha Mayergoyz and other members of the law firm of Jones Day represented Myriad in this matter.

About Myriad Genetics

Myriad Genetics, Inc. (Nasdaq:MYGN – News) is a leading molecular diagnostic company dedicated to developing and marketing transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess a patient’s risk of disease progression and disease recurrence. Myriad’s portfolio of nine molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a focus on improving an individual’s decision making process for monitoring and treating disease. With fiscal year 2011 annual revenue of over $400 million and more than 1,100 employees, Myriad is working on strategic directives, including new product introductions, companion diagnostics, and international expansion, to take advantage of significant growth opportunities. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G

Safe Harbor Statement

Original post:
Supreme Court of the United States Remands Gene Patenting Case

Comments Off »

Posted in Molecular Genetics

Tags:

Horizon in global genetics initiative

March 27th, 2012

Cambridge based Horizon Diagnostics (HDx), a division of Horizon Discovery the personalised medicines facilitator is involved in a global cancer diagnostic testing initiative.

HDx will provide genetically defined human cell line reference standards for distribution to molecular diagnostic laboratories around the world, as part of EMQNs annual External Quality Assessment (EQA) schemes to ensure sensitivity and reproducibility of diagnostic assays.

The reference materials provided by Horizon will contain known frequencies of mutations that currently guide the prescription of cancer therapies, and particularly melanoma, colon and lung cancers.

They will be distributed to participants in EMQNs proficiency testing schemes, which will be assessed for their ability to accurately test the samples and provide a clear and concise report on the results.

Diagnostic EQA providers face significant difficulties in sourcing reliable reference materials for diagnostics testing, either from patient samples or immortalised cell lines, especially as increasing numbers of rare mutations are being discovered.

Horizons reference standards overcome this by reconstituting mutations of interest in human cell lines using its proprietary genome editing technology, GENESIS, and creating a defined wild-type parental to mutant ratio in each sample.

Dr Paul Morrill, commercial director, Horizon Discovery Business Weeklys newly-elected Business of the Year, said: Quality assurance schemes such as those organized by EMQN are essential to ensure that patients receive the correct treatment regimen based on their tumour mutation status.

Horizons technology offers pathologists and biologists an unprecedented level of control, and a resource for benchmarking the performance of assays against validated empirical reference standards. This is an invaluable component of patient care.

Dr Simon Patton, director of EMQN, added: The availability of Horizons defined reference standards enables vastly improved proficiency testing across the diagnostics industry.

We look forward to working with Horizon on developing standards for the increasing number of clinically relevant mutations that are supported through our EQA schemes.

See the original post:
Horizon in global genetics initiative

Comments Off »

Posted in Molecular Genetics

Tags:

Response Genetics, Inc. Announces Year-End and Fourth Quarter Financial Results

March 27th, 2012

LOS ANGELES–(BUSINESS WIRE)–

Response Genetics Inc. (Nasdaq: RGDX – News), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced its consolidated financial results and business progress for the full year and fourth quarter ended December 31, 2011.

Total revenue for the year ended December 31, 2011 increased to $22.6 million, compared to $21.3 million for the year ended December 31, 2010, an increase of 6.4 percent. The increase was due primarily to an increase in ResponseDX revenues which increased 11 percent to $12.5 million for the year ended December 31, 2011, compared to $11.3 million for the year ended December 31, 2010. The Companys pharmaceutical client revenue increased to $10.1 million for the year ended December 31, 2011, compared to $10.0 million for the year ended December 31, 2010.

The Companys net loss for the year ended December 31, 2011 was $5.7 million or a loss of $0.30 per share, compared with a net loss of $4.7 million, or a loss of $0.26 per share, for the year ended December 31, 2010.

Total revenue for the fourth quarter ended December 31, 2011 was $4.9 million, compared to $6.4 million for the same period in 2010. The decrease was primarily due to a decrease in pharmaceutical client revenue, with the majority of the decrease due to the near completion of the clinical trials conducted on behalf of GlaxoSmithKline. Revenue from ResponseDX genetic tests was approximately $3.1 million for the fourth quarter ended December 31, 2011, a slight increase over the comparable period in 2010 while pharmaceutical client revenue was approximately $1.8 million.

The Companys net loss for the fourth quarter ended December 31, 2011 was $3.9 million, or a loss of $0.21 per share, compared to a net loss of $1.1 million, or a loss of $0.06 per share, for the same period last year.

I am very excited to have joined Response Genetics in late December and am quite enthusiastic about the significant role the Company can have in personalized medicine, said Thomas Bologna, Chairman and Chief Executive Officer. We are pleased to see that ResponseDX testing revenues grew 11 percent year over year while appreciating that our bottom line was negatively affected by various expenditures in the fourth quarter that are not expected to reoccur in 2012. There remains a lot of hard work to do. Now that we completed the successful financing in February of this year, our primary near-term priorities are to build out the management team, implement several operational enhancements, expand our sales force, strengthen our marketing and back-office capabilities and focus on growing our suite of ResponseDX products. We will also be looking to establish new collaborations with pharmaceutical clients through our services business.

Additional Year-End and Fourth Quarter 2011 Financial Results

Gross margin for the year ended December 31, 2011 was approximately 48 percent compared to approximately 51 percent for the year ended December 31, 2010. Gross margin is Net Revenue less Cost of Revenue. The decrease in gross margin was largely the result of decreased pharmaceutical revenue in the third and fourth quarter and certain expenses incurred in the fourth quarter, which are not expected to reoccur in 2012. Excluding cost of revenue, total operating expenses for the year ended December 31, 2011 were $16.6 million, compared with $15.7 million for the year ended December 31, 2010. The increase in total operating expenses of $0.9 million was due to an increase in general and administrative expenses of $1.6 million, offset by a decrease in sales and marketing expenses of $0.4 million and a decrease in research and development expenses of $0.3 million. The increase in general and administrative expenses was due to higher personnel costs, consulting fees and bad debt expense (see paragraph below).

Gross margin for the fourth quarter ended December 31, 2011 was approximately 25 percent compared to approximately 52 percent for the comparable period in 2010. The decrease in gross margin was largely the result of a decrease in pharmaceutical revenue of $1.5 million and other incremental expenses totaling $0.6 million related to recruiting costs and regulatory and laboratory management consulting expenses which are not expected to reoccur in 2012.

Read more:
Response Genetics, Inc. Announces Year-End and Fourth Quarter Financial Results

Comments Off »

Posted in Molecular Genetics

Tags:

Response Genetics, Inc. Announces Appointment of Stephanie Astrow, Ph.D., as Vice President, Research and Development

March 27th, 2012

Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, announced today the addition of Stephanie H. Astrow, Ph.D., as the Companys Vice President for Research and Development. In her role, Dr. Astrow will be responsible for leading the companys research and development programs, as well as identifying and incorporating new technologies into the services that the Company provides to the medical community.

With her strong background in the oncology molecular diagnostics industry we believe Stephanie is the perfect fit to lead our R&D efforts, said Thomas Bologna, Chairman and Chief Executive Officer of Response Genetics. Stephanies track record of identifying and developing biomarker assays and driving scientific innovation to expand business will be a tremendous asset to us and we are looking forward to her contributions.

Dr. Astrow brings extensive experience in molecular diagnostics research and development as well as operational experience to her role at Response Genetics. Most recently, Dr. Astrow was Scientific Director for Oncology at Quest Diagnostics, the largest global provider of diagnostic testing. At Quest, she played a key role in expanding business by introducing new assays and services, as well as coordinating development strategy for companion diagnostics with key pharmaceutical companies. Prior to her work at Quest, Dr. Astrow served as Vice President and Director of Oncology at Pathway Diagnostics, and Vice President, Scientific Director of Impath, Inc. Dr. Astrow received a Bachelor of Arts in Biology and Medicine at Brown University, and her Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. She also holds a Masters of Business Administration from Pepperdine University.

Dr. Astrow, commenting on her appointment said, I couldnt be more excited to be joining Response Genetics, a company that matches my background and interests very well. I look forward to putting my skills and experience to work in helping people with cancer, and being part of a company that is both patient-centric and well suited to prosper in the exciting field of personalized diagnostics.

About Response Genetics, Inc.

Response Genetics Inc. (RGI) is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. RGIs principal customers include oncologist, pathologists and hospitals. In addition to diagnostic testing services, the Company generates revenue from the sales of its analytical testing services of clinical trial specimens to the pharmaceutical industry. RGI was founded in 1999 and its principal headquarters are located in Los Angeles, California. For additional information, please visit www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of RGI related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Companys plans, objectives, projections, expectations and intentions, such as the ability of the Company to continue to execute on its business strategy and operations, the ability to expand our test panels, the ability , and other statements identified by words such as projects, may, could, would, should, believes, expects, anticipates, estimates, intends, plans or similar expressions.

These statements are based upon the current beliefs and expectations of the Companys management and are subject to significant risks and uncertainties, including those detailed in the Companys filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Companys control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

Read more here:
Response Genetics, Inc. Announces Appointment of Stephanie Astrow, Ph.D., as Vice President, Research and Development

Comments Off »

Posted in Molecular Genetics

Tags:

This Week in the Journal of Molecular Diagnostics

March 24th, 2012

In the Journal of Molecular Diagnostics, researchers led by Hospital de Terrassa’s Miguel Carballo describe using long-range PCR and next-generation sequencing to detect BRCA1 and BRCA2 mutations in people with personal or family history of breast or ovarian cancer. From this, the researchers say they could detect variations within BRCA1 and BRCA2. “Our approach demonstrates that genomic LR-PCR, together with NGS, using the GS Junior 454 System platform, is an effective method for patient sample analysis of BRCA1 and BRCA2 genes,” Carballor and his colleagues write. “In addition, this method could be performed in regular molecular genetics laboratories.”

Also in the Journal of Molecular Diagnostics, Madhuri Hegde from Emory University and her colleagues report their assessment of solution-based hybridization and microdroplet-based PCR target enrichment, both coupled with next-generation sequencing, to identify mutations in genes associated with congenital muscular dystrophies. While they found that both approaches produce results that could be used in clinical labs, the researchers say that “microdroplet-based PCR target enrichment is more appropriate for a clinical laboratory, due to excellent sequence specificity and uniformity, reproducibility, high coverage of the target exons, and the ability to distinguish the active gene versus known pseudogenes.”

Visit link:
This Week in the Journal of Molecular Diagnostics

Comments Off »

Posted in Molecular Genetics

Tags:

Myriad Genetics Shares Plunged Temporarily: What You Need to Know

March 22nd, 2012

By Sean Williams | More Articles March 20, 2012 |

Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.

What: Shares of molecular diagnostics company Myriad Genetics (Nasdaq: MYGN) dipped 10% earlier in today’s trading session following an unfavorable patent ruling for one of the company’s peers.

So what: This morning, a U.S. court ruled against Prometheus Laboratories, a unit of Nestle (yes, the maker of those delicious chocolate bars), stating that it could not patent a diagnostic method to observe changes in a patients body to determine the best drug dosage for certain diseases. Since companies like Myriad have similar diagnostic technologies, and these companies rely on patents to protect their technology, this could be a major blow to the sector.

Now what: Ive long been a Myriad bull, and Im not ready to throw in the towel on one specific ruling. But, I have to admit that todays patent rejection doesnt exactly let shareholders sleep easier at night. At 17 times forward earnings, the stock seems fairly valued. Its definitely a company Id add to my watchlist considering the boom in diagnostic medicine expected over the next decade.

Craving more input? Start by adding Myriad Genetics to your free and personalized watchlist so you can keep up on the latest news with the company.

Read more here:
Myriad Genetics Shares Plunged Temporarily: What You Need to Know

Comments Off »

Posted in Molecular Genetics

Tags:

AMP applauds Supreme Court ruling: Sees win for patients and personalized medicine

March 22nd, 2012

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Mary Steele Williams mwilliams@amp.org 301-634-7321 Association for Molecular Pathology

Bethesda, MD, March 21, 2012: “The Association for Molecular Pathology (AMP) applauds the U.S. Supreme Court’s ruling today in the case of Mayo Collaborative Services v. Prometheus Laboratories as a victory for patients and for the advancement of personalized medicine,” stated Iris Schrijver, MD, the Organization’s President. AMP, an international professional society representing more than 2000 physicians, doctoral scientists, and medical technologists, joined 10 other medical and healthcare organizations in filing an amicus brief with the Court in support of Mayo Clinic. AMP is also the lead plaintiff in Association for Molecular Pathology v. U.S. Patent and Trademark Office that challenges the validity of patents on two human genes associated with hereditary breast and ovarian cancer and is currently under review by the High Court.

“Prometheus acknowledged that physicians can infringe the patent by merely thinking about the relationship between drug metabolite levels and patient response,” asserted Dr. Schrijver. “It is encouraging that the Court recognized that the Prometheus patents neither promote the advancement of medical practice, nor benefit patient care”.

“In Prometheus, the Court wisely recognized that overly broad patents can inhibit innovation,” stated Jennifer Hunt, MD, MEd, the Organization’s President-Elect. “Establishing a drug reference range is important, but standard work for laboratory physicians. Awarding monopolies over the medical use of natural, biological relationships stifles innovation in true diagnostic test methods and obstructs improvements for patient care.”

AMP believes the Supreme Court’s reasoning in Mayo v. Prometheus extends to patents that claim ownership over another type of natural phenomenon, the biological relationships between genetic variants and clinical disease. Such relationships are at the heart of personalized medicine. “Patients are increasingly being disadvantaged by gene correlation patents,” stated Roger D. Klein, MD, JD, Chair of AMP’s Professional Relations Committee. As an example, Dr. Klein cited a method patent relating to a variation in a gene known as FLT3 that is used to qualify some leukemia patients for bone marrow transplant.

Enforcement of the FLT3 patent by a private company has been forcing physicians and laboratories to split and geographically distribute irreplaceable bone marrow specimens. “Splitting samples creates an additional risk of specimen loss and delays the receipt of patient results” stated Dr. Klein. “In addition, it interferes with the ability of pathologists to provide synoptic interpretations involving multiple tests, and prevents them from implementing cost saving algorithms that limit unnecessary testing. The Supreme Court’s ruling is clearly a win both for our patients and for personalized healthcare.”

###

ABOUT AMP:

The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit www.amp.org.

See original here:
AMP applauds Supreme Court ruling: Sees win for patients and personalized medicine

Comments Off »

Posted in Molecular Genetics

Tags:

Response Genetics, Inc. to Release Fourth Quarter and Full-Year 2011 Financial Results and Host Conference Call on …

March 22nd, 2012

LOS ANGELES–(BUSINESS WIRE)–

Response Genetics, Inc. (Nasdaq:RGDX – News), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its fourth quarter and full-year 2011 financial results and an operational update in a press release to be issued before the market opens on Tuesday, March 27, 2012. The company will host a conference call that same day at 10:00 a.m. EDT to discuss its financial results.

CONFERENCE CALL DETAILS

To access the conference call by phone on March 27 at 10:00 a.m. EDT, dial (800) 537-0745 or (253) 237-1142 for international participants. A telephone replay will be available beginning approximately two hours after the call through April 3, and may be accessed by dialing (855) 859-2056, (404) 537-3406, or (800) 585-8367. The reply passcode is 64520370.

To access the live and archived webcast of the conference call, go to the Investor Relations section of the Company’s Web site at http://investor.responsegenetics.com. It is advised that participants connect at least 15 minutes prior to the call to allow for any software downloads that might be necessary.

About Response Genetics, Inc.

Response Genetics Inc. (RGI) is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. RGIs principal customers include oncologist, pathologists and hospitals. In addition to diagnostic testing services, the Company generates revenue from the sales of its analytical testing services of clinical trial specimens to the pharmaceutical industry. RGI was founded in 1999 and its principal headquarters are located in Los Angeles, California. For additional information, please visit www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of RGI related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Companys plans, objectives, projections, expectations and intentions, such as the ability of the Company to announce its financial results and provide a conference call, to continue to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, , to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into new areas such as companion diagnostics, and to continue to execute on its business strategy and operations, to continue to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as projects, may, could, would, should, believes, expects, anticipates, estimates, intends, plans or similar expressions.

Follow this link:
Response Genetics, Inc. to Release Fourth Quarter and Full-Year 2011 Financial Results and Host Conference Call on …

Comments Off »

Posted in Molecular Genetics

Tags:

UGA Researchers Win NSF Career Grants for Molecular Fly, Lizard Studies

March 22nd, 2012

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Two University of Georgia genetics researchers have landed $1.8 million in new National Science Foundation grants to fund genomics and molecular biology studies, UGA said yesterday.

Kelly Dyer and Douglas Menke, both assistant professors of genetics at UGA, each have won Faculty Early Development Career Program awards under its Directorate for Biological Sciences.

Dyer will use her $1 million grant to study the genetic basis of mating behaviors and how new species form by looking at a group of Drosophila that has “very elaborate” courtship practices, she said.

“In the quinaria group of Drosophila flies we are studying, some females are very picky about which males they will mate with, while others are less picky and will even mate with males from a different species,” Dyer explained. “Ultimately, we want to know whether the genes that enable a female to distinguish a male from a different species are also involved in discriminating among potential mates from her own species. This will tell us if the processes that reinforce barriers between species may also trigger reproductive isolation within a species.”

The findings from this study could provide insights into whether two different species will merge or remain distinct when they come into contact knowledge that could be useful as human expansion is pressing more animal groups into smaller geographic ranges.

Menke received a $790,000 award to study the molecular mechanisms involved in differing limb lengths in Anolis lizards found in the Caribbean. His team will collect samples from around the Caribbean and study the growth patterns of limbs during embryonic development at the molecular level.

Menke’s team aims to discover how the controls for limb size and shape operate, and potentially how genetic mutations in humans can alter limb growth and lead to congenital birth defects.

The research will help scientists determine how limb size and shape are controlled. The findings may also aid in understanding how genetic mutations in humans can alter limb growth and result in congenital birth defects of the extremities.

Read the original:
UGA Researchers Win NSF Career Grants for Molecular Fly, Lizard Studies

Comments Off »

Posted in Molecular Genetics

Tags:






Personalized Gene Medicine | Mesenchymal Stem Cells | Stem Cell Treatment for Multiple Sclerosis | Stem Cell Treatments | Board Certified Stem Cell Doctors | Stem Cell Medicine | Personalized Stem Cells Therapy | Stem Cell Therapy TV | Individual Stem Cell Therapy | Stem Cell Therapy Updates | MD Supervised Stem Cell Therapy | IPS Stem Cell Org | IPS Stem Cell Net | Genetic Medicine | Gene Medicine | Longevity Medicine | Immortality Medicine | Nano Medicine | Gene Therapy MD | Individual Gene Therapy | Affordable Stem Cell Therapy | Affordable Stem Cells | Stem Cells Research | Stem Cell Breaking Research

Web Design by PlatinumShore.com & Web Hosting by TradeWebHosting.com