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Biomatrica completes $5 million in private financing

Biomatrica, Inc., a leader in ambient temperature biostability technology, today announced the completion of $5 million in private financing. Biomatrica has developed SampleMatrix technology which has pioneered recent innovations in ambient storage of biological samples, from purified DNA, RNA, and proteins to complex systems such as tissue, cell lines, biopsies and whole blood.

6 Dec 2012

China's SFDA approves QIAGEN careHPV Test and instrument platform

QIAGEN N.V. today announced that China's State Food and Drug Administration (SFDA) has approved QIAGEN's careHPV Test and instrument platform.

From QIAGEN Manchester Limited 29 Nov 2012

Vermillion’s OVA1 diagnostic test effectively identifies early-stage ovarian cancer

Gynecologic Oncology, the prestigious medical journal of the Society for Gynecologic Oncology, has published the second prospective clinical study of OVA1 which demonstrated the positive performance of the multi-biomarker test in the triage of early-stage ovarian cancer.

29 Nov 2012

Roche’s cobas 4800 HPV Test receives CE mark

Roche today announces an expanded CE mark indication for the cobas 4800 HPV Test. The newly expanded indication for the cobas® 4800 HPV Test as a primary screen means Pap cytology is no longer required as a co- or pre-test in countries that accept a CE mark.

From Roche Sequencing and Life Science 27 Nov 2012

New report analyzes annual trends for biomarker FDA approvals since 2008

"Approval Trends for Biomarker-Based IVD Tests: Realizing the Promise of Personalized Medicine," a new report published by Amplion Research analyzes annual trends for FDA approvals since 2008 with some interesting findings.

27 Nov 2012

Abacus Diagnostica’s GenomEra C. difficile assay receives CE mark

Abacus Diagnostica Ltd announced that it has received the CE mark for the GenomEra C. difficile assay for the detection of toxin-producing Clostridium difficile directly from stool samples. C. difficile is the leading cause of infectious nosocomial diarrhea in Europe and North America.

19 Nov 2012

Affymetrix reports net loss of $17.9 million for third quarter 2012

Affymetrix, Inc., today reported its operating results for the third quarter of 2012. Total revenue for the quarter was $79.6 million, including approximately $17.6 million in revenue from eBioscience during the third quarter of 2012. This compares to total revenue of $64.0 million for the same period of 2011.

5 Nov 2012

Microbiologists confirm existence of new tick disease in Switzerland

Until now, we knew that ticks primarily transmit two pathogens to humans in Switzerland: the bacterium Borrelia burgdorferi - which causes borreliosis - and the early-summer-meningoencephalitis virus, which can cause cerebral inflammation. Now, microbiologists from the University of Zurich confirm the existence of another tick disease in Switzerland - neoehrlichiosis.

1 Nov 2012

AMP report provides overview of next generation sequencing technology

The Association for Molecular Pathology published the report of the Whole Genome Analysis Working Group of the AMP Clinical Practice Committee in the November 2012 issue of The Journal of Molecular Diagnostics.

20 Oct 2012

Johns Hopkins, Iverson enter licensing agreement for molecular diagnostics

Iverson Genetic Diagnostics, Inc. announced today an exclusive licensing agreement with Johns Hopkins University School of Medicine under which Iverson receives global exclusive commercialization rights for molecular diagnostics that are designed to help physicians to assess cardiovascular risk in men and women and infertility risk in women.

12 Oct 2012

Roche announces availability of new HIV-1 viral load test in the U.S.

Roche announced today the U.S. availability of a new HIV-1 viral load test based on the company's proprietary dual-target approach. The COBAS TaqMan HIV-1 Test v2.0 for use with the High Pure System enables labs to combine an FDA-approved process for manual specimen preparation with an automated real-time PCR analyzer for amplification and detection.

From Roche Sequencing and Life Science 4 Oct 2012

PAM50 potentially simplifies underlying breast tumor biology

On September 23, researchers published online in the journal Nature a study of the molecular biology of breast cancer, using the intrinsic subtypes as defined by the PAM50 gene signature as an organizing framework for analyzing genomic and proteomic aberrations. This landmark study both underscores the emergence of the intrinsic subtypes as a powerful taxonomy of breast cancer in research, and PAM50's role as the gold standard for categorizing breast cancer by subtype.

From NanoString Technologies 25 Sep 2012

New test to assess viral load of cytomegalovirus

Roche announced today the commercial availability of a new test to assess a patient's viral load of cytomegalovirus (CMV). Physicians use information from the test to help them manage patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation.

From Roche Sequencing and Life Science 17 Sep 2012

PrimeraDx’s ICEPlex system and C. difficile detection assay receive CE mark

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex system, a quantitative multiplex PCR system, and their C. difficile detection assay both received the CE mark.

12 Sep 2012

Ingenuity Systems, ShanghaiBio sign collaboration agreement

ShanghaiBio Corporation and Ingenuity Systems have signed a collaboration agreement enabling ShanghaiBio Corporation to extend its current lab service offering to include Ingenuity solutions for downstream analysis and interpretation of genomics data. ShanghaiBio Corporation will complement their sequencing, genotyping and gene expression lab services by creating a bundled solution with Ingenuity's applications, which combine analytics and biomedical content to help get actionable insights from experiments.

6 Sep 2012

Akonni receives NSF's Phase 2 SBIR Grant to develop Lab-on-a-Film microarray

Akonni Biosystems, a life science tools / molecular diagnostics company that develops, manufactures, and plans to market molecular testing devices for diagnosing infectious diseases and human genetic disorders, announced today the receipt of a $498,780 Phase 2 SBIR Grant from the National Science Foundation (NSF).

6 Sep 2012

New York State Department of Health issues license to Veracyte's Afirma Gene Expression Classifier

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, and Genzyme, a Sanofi company, today announced that the New York State Department of Health has issued a license enabling Veracyte's Afirma Gene Expression Classifier to be offered to patients in the state.

30 Aug 2012

NUI Galway project hopes to deliver cost effective tool for rapid diagnosis of pneumonia

Researchers at NUI Galway are involved in a new European project which hopes to deliver a cost effective tool for the speedy diagnosis of infections such as pneumonia. The test would reduce diagnosis time from days to hours, so that the appropriate treatments can be administered as early as possible for the best possible outcome.

29 Aug 2012

U-M, IGC launch new joint venture for personalized medicine

As a key step toward providing patients with treatments based on their own DNA profiles, the University of Michigan and the International Genomics Consortium (IGC) have launched a new joint venture that will help usher in an age of personalized medicine.

17 Aug 2012

MedPage Today, CollabRx sign license agreement for Oncology Next

Tegal Corporation today announced that its recently acquired CollabRx, Inc., subsidiary signed an exclusive license agreement to provide a version of its proprietary Therapy Finder tool to MedPage Today, Everyday Health, Inc.'s rapidly growing online site that serves 96% of all oncologists and 1.6 million monthly online unique users.

9 Aug 2012