Molecular Diagnostics News and Research

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FDA approves Roche's real-time PCR COBAS TaqMan HCV Test, v2.0

Roche announced today that the U.S. Food & Drug Administration (FDA) has approved the real-time PCR COBAS® TaqMan® HCV Test, v2.0. Clinical research organizations have depended on COBAS® TaqMan® technology to support hepatitis C pharmaceutical trials and development.

25 Oct 2010

ThermalTherapeutic Systems, Applied Medical enter strategic alliance

ThermalTherapeutic Systems, Inc., the developer of a highly portable platform technology designed to standardize hyperthermic perfusion treatments, today announced a strategic alliance with Applied Medical Products and Solutions of Boston, MA.

25 Oct 2010

GE Healthcare signs definitive agreement to acquire Clarient

GE Healthcare, a unit of General Electric Company and Clarient, Inc. announced today that they have entered into a definitive agreement for GE Healthcare to acquire Clarient, a leading player in the fast-growing molecular diagnostics sector.

25 Oct 2010

Matrix-Bio's VeraMarker-BCR blood test predicts breast cancer recurrence 13 months before clinical diagnosis

Connie Krabbe understands the fear and foreboding breast cancer survivors feel when visiting their physicians for post-treatment check-ups. Two of her four sisters died of metastatic cancer related to breast cancer, enduring bone, brain, and ovarian cancer before succumbing to the disease in their early 50s.

21 Oct 2010

UK IPO rejects revocation action by Biogene against Enigma's patents

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced that the UK Intellectual Property Office (IPO) has rejected a revocation action brought by Biogene against three patents licensed exclusively to Enigma by the Defence Science and Technology Laboratory (Dstl), part of the UK Ministry of Defence.

18 Oct 2010

New, affordable technology for cervical cancer screening

Current cervical cancer screening is time consuming and expensive, but now new breakthrough technology developed by European researchers should allow large-range screening by non-medical personnel with almost immediate results and at a much lower cost.

15 Oct 2010

IMD receives EPO patent for NADiA ultra-sensitive protein detection and cell phenotyping platform

IRIS International, Inc. a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that Iris Molecular Diagnostics (IMD)has been granted Patent No. EP1842226B1 by the European Patent Office (EPO) covering aspects of IMD's NADiA ultra-sensitive protein detection and cell phenotyping platform, which can detect proteins in the femtogram (1 quadrillionth) per milliter range and phenotype single cells.

14 Oct 2010

AusBiotech 2010 set to demystify the impact of US Healthcare Reforms on Australian biotech

Australian biotechnology and pharmaceutical companies are seeking to understand the implications of the US Healthcare Reform Bill, says Australia’s biotechnology industry organisation, AusBiotech. In order to remain compliant and globally competitive, biotechs need to identify and work within a gamut of new requirements, complications and hurdles imposed by this new regulatory environment.

13 Oct 2010

TrovaGene receives patent for diagnosis and monitoring of pathogenic infection

TrovaGene, Inc. a developer of transrenal molecular diagnostics to facilitate personalized medicine, received notice of U.S. Patent 7,803,929 entitled "Kits for diagnosis and monitoring of pathogenic infection by analysis of cell-free pathogenic nucleic acids in urine."

13 Oct 2010

Sirius collaborates with Golden Helix to advance diagnostic pipeline

Sirius Genomics, a developer of companion diagnostics, and Golden Helix, a global leader in genetic analysis solutions, announced today a collaboration under which Golden Helix will apply its expertise and technologies in SNP and copy number variant analysis and predictive modeling to advance development of Sirius' diagnostic pipeline.

13 Oct 2010

Akonni receives NIJ grant to develop HCID system for SNP identification

Akonni Biosystems, a molecular diagnostics company that develops, manufactures, and plans to market sophisticated genetic testing devices for diagnosing complex infectious and human diseases, today announced receipt of a nearly $500,000 Phase III Grant from the National Institutes of Justice (NIJ).

13 Oct 2010

QIAGEN, Abbott enter agreement to strengthen testing menus for automated in-vitro diagnostic applications

QIAGEN and Abbott today announced that they have entered into an agreement that significantly strengthens both companies' testing menus for automated in-vitro diagnostic applications in the United States and Canada. Financial terms were not disclosed.

From QIAGEN Manchester Limited 13 Oct 2010

Elsevier, AMP, ASIP to publish The Journal of Molecular Diagnostics

Elsevier, a world-leading publisher of scientific, technical and medical information products and services, is pleased to announce that as of January 2011 Elsevier will publish The Journal of Molecular Diagnostics (JMD) in partnership with the Association for Molecular Pathology (AMP) and the American Society for Investigative Pathology (ASIP).

12 Oct 2010

Roche, DKFZ announce research collaboration to predict cervical cancer risk

Roche Molecular Systems, Inc. and the German Cancer Research Center announced today that they have entered into a research collaboration to enable more specific prediction of a woman's risk for developing cervical cancer.

From Roche Sequencing and Life Science 11 Oct 2010

Cepheid collaborates with Novartis to commercialize BCR-ABL monitoring test

Cepheid today announced an exclusive collaboration with Novartis for the commercialization of a test for monitoring the BCR-ABL gene transcript in peripheral blood specimens from patients diagnosed with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). Together with other lab tests, monitoring levels of BCR-ABL transcripts in Ph+ CML patients will aid in patient management.

7 Oct 2010

Pathwork Diagnostics closes $30M Series C financing

Pathwork Diagnostics, Inc, a privately held molecular diagnostics company focused on oncology, today announced the closing of its $30 million Series C financing. Led by Alta Partners, the financing included participation from the company's existing investors: Abingworth, Advent Venture Partners, Novus Ventures, Prospect Venture Partners and Venrock.

6 Oct 2010

cobas TaqScreen DPX Test now available with CE Mark: Roche

Roche announced today that the cobas TaqScreen DPX Test for use on the cobas s 201 system is now available with the CE Mark. It is the first IVD test to offer complete coverage of all human genotypes of parvovirus B19 (B19V) and hepatitis A virus (HAV) in one assay.

5 Oct 2010

Breast cancer breakthrough

New research on gene expression provides a breakthrough in breast cancer treatment. Women who have triple-negative breast cancer are a small proportion of breast cancer cases, but it is difficult to treat and might have a more aggressive clinical course than other forms of the disease.

30 Sep 2010

Prix Galien USA committee honors life saving innovations

The Prix Galien USA committee honored innovations that are saving lives last night during the Prix Galien Awards Gala. The Pro Bono Humanum Award, the Prix Galien USA 2010 and the Prix Galien International were presented and related accomplishments celebrated.

30 Sep 2010

AccuPSA test for detecting prostate cancer recurrence

A new test could reliably detect early increases in prostate specific antigen (PSA) levels a biomarker commonly used to measure the recurrence of prostate cancer in men who have undergone prostate cancer treating surgery. Earlier detection of these rising levels would allow men with cancer recurrence to undergo earlier, more effective treatment for potentially better outcomes.

30 Sep 2010