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FDA categorizes Cepheid's Xpert CT/NG test as 'Moderate Complexity' under CLIA

Cepheid today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert CT/NG test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA).

17 Jan 2013

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations.

17 Jan 2013

Debiopharm, Spinomix announce closing of Series A equity financing

Debiopharm Group (Debiopharm) and Spinomix SA, a Swiss company advancing molecular diagnostic technologies, announced the closing of a Series A equity investment of $ 3 Million.

9 Jan 2013

Trovagene, MD Anderson partner to detect transrenal BRAF mutations in metastatic cancers

Trovagene, Inc., a developer of transrenal molecular diagnostics, announced that it has entered into a clinical collaboration with The University of Texas MD Anderson Cancer Center to detect transrenal BRAF mutations in the urine of patients with advanced or metastatic cancers.

3 Jan 2013

Trovagene adds Duke University Health System to worldwide licensees of NPM1 marker for AML

Trovagene, Inc., a developer of transrenal molecular diagnostics, announced it has granted Duke University and Duke University Health Systems a non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services for acute myelogenous leukemia (AML).

27 Dec 2012

Fluidigm, GIS announce establishment of first single-cell genomics research center in Asia

The Genome Institute of Singapore (GIS), an institute under the umbrella of the Agency for Science, Technology and Research, and Fluidigm Corporation today announced the establishment of the first research center in Asia exclusively dedicated to accelerating the understanding of how individual cells work, and how diagnosis and treatment might be enhanced through insight derived from single cells.

15 Dec 2012

China SFDA approves Veridex’s CellSearch test for women with metastatic breast cancer

Veridex, LLC today announced approval from the China State Food & Drug Administration (SFDA) for the CellSearch circulating tumor cell (CTC) test as an in vitro diagnostic for women with metastatic breast cancer.

13 Dec 2012

New diagnostic assay for screening ALK fusions in non-small cell lung carcinoma

Approximately one in 20 patients with non-small cell lung carcinoma (NSCLC) has chromosomal aberrations targeting the anaplastic lymphoma kinase (ALK) gene. This has considerable implications for treatment because these patients are highly responsive to ALK-specific kinase inhibitors such as crizotinib.

From NanoString Technologies 13 Dec 2012

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