Molecular Diagnostics News and Research

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Nuvera announces results of blinded study on breast cancer assay for taxane chemotherapy response

Nuvera Biosciences, a molecular diagnostics company that develops gene-based diagnostic assays for personalized medicine in cancer, announced the results of a blinded validation study on its breast cancer assay for taxane chemotherapy response.

4 Jun 2011

Rheonix to receive U.S. patent for powerful microfluidic platform

Rheonix, Inc., developer of the Rheonix CARD system that provides a powerful microfluidic platform for the evolving molecular diagnostics industry, announced that on June 14, 2011 the U.S. Patent and Trademark Office will issue Patent Number 7,959,875, "Microfluidic Chips and Assay Systems," and on April 13, 2011 it allowed Patent Application Number 11/594,444, "Microfluidic Systems," to the Company.

3 Jun 2011

Clovis Oncology, Roche partner to develop in vitro PCR-based diagnostic test for NSCLC

Clovis Oncology, Inc. and Roche, announced today that they have entered into an agreement to develop an in vitro PCR based companion diagnostic test.

2 Jun 2011

EPO awards Trilink patent for CleanAmp Primers

TriLink BioTechnologies, Inc., a leader in manufacturing high quality oligonucleotides and nucleoside triphosphates, announced today the award of their CleanAmp Primer patent by the European Patent Office (EPO Patent no. 2032714).

27 May 2011

OVA1 more effective than CA 125 test in evaluating likelihood of ovarian cancer

A paper published in the June issue of Obstetrics & Gynecology demonstrated that adding OVA1 to a physician's preoperative assessment of a woman's ovarian mass would identify more ovarian cancers than a physician's preoperative assessment alone.

From Quest Diagnostics 27 May 2011

Roche's new cobas TaqScreen MPX viral discriminatory test, v2.0 now available in Europe

Roche announced today that the cobas TaqScreen MPX Test, version 2.0 for use on the cobas s 201 system is now commercially available in Europe.

23 May 2011

Lab21 acquires molecular diagnostics company Myconostica Ltd

Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics has today announced that it has acquired Myconostica Ltd, a molecular diagnostic company focussing on the diagnosis of fungal infections of clinical importance.

23 May 2011

Gen-Probe seeks FDA regulatory clearance for PANTHER fully automated and integrated molecular testing system

Gen-Probe Incorporated announced today that the Company has filed a 510(k) application with the US Food and Drug Administration for its PANTHER system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

20 May 2011

Abbott RealTime PCR assay for measuring HCV viral load receives FDA marketing approval

Abbott announced today that it has received approval from the U.S. Food and Drug Administration to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV), the leading cause of liver cancer in the United States.

19 May 2011

MDxHealth reduces first quarter net loss by 17%

MDxHealth SA, a leading molecular diagnostics company in the field of personalized medicine, today issued its business update for the quarter ended March 31, 2011.

18 May 2011

USPTO issues notice of allowance to Vermillion's Peripheral Artery Disease biomarker patent

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent entitled "Panel of Biomarkers for Peripheral Artery Disease" to the company.

18 May 2011

GenturaDx completes external HSV 1&2 alpha studies for IDbox System

Molecular diagnostics company GenturaDx announces the completion of external HSV 1&2 alpha studies for its IDbox instrument and cassette-based tests. Conducted at an external CLIA laboratory, the study analyzed more than 130 samples, including more than 70 clinical specimens.

16 May 2011

Study: OVA1 blood test can accurately predict ovarian cancer in women with pelvic masses

A study published online ahead of print in the June 2011 edition of Obstetrics & Gynecology demonstrated that American College of Obstetrics and Gynecology guidelines for determining the likelihood that an ovarian mass is cancerous prior to surgery would accurately identify more women with ovarian cancer if the OVA1 blood test were used in place of the currently recommended CA 125 blood test.

From Quest Diagnostics 13 May 2011

Epigenomics presents Septin9 blood test study data in colorectal cancer at DDW 2011

Epigenomics AG, the cancer molecular diagnostics company, reports that Dr. Uri Ladabaum, Associate Professor in the Department of Gastroenterology and Hepatology at the School of Medicine of Stanford University, has presented the results of a health economic analysis of potential future colorectal cancer screening with Septin9 blood tests at the ongoing Digestive Disease Week 2011.

9 May 2011

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

Epigenomics AG, the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions.

7 May 2011

Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

Roche announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests.

7 May 2011

ChipDX identifies gene expression signature in early-stage breast tumors

ChipDX LLC, a New York-based molecular diagnostics and personalized medicine research company, has discovered a gene expression signature present in the cells of early-stage breast tumors that indicates the chance of the tumor recurring within 10 years.

4 May 2011

Eurotrans-Bio awards 1.1 million grant to MDxHealth, NovioGendix for bladder cancer program

MDxHealth SA, a leading molecular diagnostics company in the field of personalized cancer treatment, today announced that together with partner NovioGendix B.V., a molecular diagnostics company spun out from Radboud University Nijmegen Medical Centre, the Netherlands, has received a USD 1.1 million grant from Eurotrans-Bio to progress its bladder cancer program.

3 May 2011

Caliper first quarter revenue increases 25% to $35.8 million

Caliper Life Sciences, Inc., today reported its financial results for the first quarter of 2011. First quarter revenue increased to $35.8 million, or 25%, from $28.7 million in the same period of 2010.

2 May 2011

FDA grants Cepheid marketing clearance for Xpert Flu diagnostic test

Cepheid today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® Flu. The diagnostic test, which runs on Cepheid's GeneXpert® System, simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour.

26 Apr 2011