Molecular Diagnostics News and Research

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Article explores benefits of innovative programs for personalized health care

Two innovative programs designed to improve the availability of emerging medical technologies that can help patients receive more effective, efficient and personalized health care are advanced in a commentary written by a team of scientists and policy experts, including seven from Arizona State University, and published today in Science Translational Medicine.

15 Mar 2013

Researchers discover new type of eye cancer that affects young babies

A team of Canadian and international cancer researchers led by Dr. Brenda Gallie at the Princess Margaret Cancer Centre, University Health Network, has discovered a new type of retinoblastoma, a rapidly developing eye cancer that affects very young babies- a finding that can immediately change clinical practice and optimize care for these children.

13 Mar 2013

IntegraGen, Lab21 collaborate to develop new microRNA assay for colorectal cancer

Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, has entered into an agreement with IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in autism and oncology, to develop a microRNA assay for colorectal cancer designed to further improve patient outcomes.

22 Feb 2013

Patient-specific cancer cell lines designed to predict chemotherapy sensitivity

In laboratory studies, scientists at the Johns Hopkins Kimmel Cancer Center have developed a way to personalize chemotherapy drug selection for cancer patients by using cell lines created from their own tumors.

15 Feb 2013

Life Technologies full year 2012 revenue increases 2% to $3.8 billion

Life Technologies Corporation today announced results for its fourth quarter for the year ended Dec. 31, 2012.

4 Feb 2013

Clarient adopts QIAGEN’s therascreen KRAS test to diagnose colorectal cancer

QIAGEN N.V. today announced that Clarient - a GE Healthcare Company and leading provider of cancer laboratory testing services in the United States - has adopted the use of the therascreen KRAS RGQ PCR Kit (therascreen KRAS test) as a companion diagnostic to guide the use of Erbitux (cetuximab) as a treatment in patients with metastatic colorectal cancer.

From QIAGEN Manchester Limited 30 Jan 2013

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