Molecular Diagnostics News and Research

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Clinical Reference Laboratory completes validation testing of DNA Genotek's Oragene-DNA saliva collection kits

Clinical Reference Laboratory today announced that it has completed validation testing of DNA Genotek's Oragene-DNA saliva collection kits and will adopt Oragene-DNA for use with its molecular diagnostic services.

25 Mar 2010

Meridian Bioscience seeks FDA marketing clearance for illumigene C. difficile molecular diagnostic test

Meridian Bioscience, Inc. announced today that it has submitted a 510(k) application to the United States Food and Drug Administration for marketing clearance of its new, simple molecular diagnostic test, illumigene™ C. difficile. illumigene is a simplified new technology platform, based upon loop amplification (LAMP) that makes molecular diagnostic testing possible for any size laboratory.

23 Mar 2010

Asuragen appoints BMD as exclusive distributor of Signature Oncology Products in France

Asuragen, Inc., a leader in the development of molecular diagnostics, announced today the appointment of Biomedical Diagnostics SA, a leading medical diagnostic company in Europe, as its exclusive distributor of Signature® Oncology Products in France. Asuragen’s Signature Oncology Portfolio comprises multiplex assays for the detection of mutations in solid and hematologic malignancies.

22 Mar 2010

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

19 Mar 2010

Roche Diagnostics named sole source supplier for Premier's blood glucose monitoring devices

Roche Diagnostics announced today that it has been awarded contracts for blood glucose monitoring and clinical chemistry/immunoassay lab analyzers from Premier Purchasing Partners, L.P., Inc., the group purchasing unit of Premier, Inc. Roche was also named the sole source supplier for blood glucose in Premier's exclusive ASCEND supply chain performance program.

From Roche Sequencing and Life Science 16 Mar 2010

NeoMed invests in CytoCore

CytoCore Inc., the developer of cost-effective products used in the practice of cytology for the detection and diagnosis of cancer and cancer related diseases, announced today that NeoMed has made an investment in CytoCore Inc.

11 Mar 2010

OVA1 blood test aids in pre-surgical evaluation of women for ovarian cancer now available through Quest Diagnostics

OVA1™, the first blood test cleared by the U.S. Food and Drug Administration (FDA) for aiding in the pre-surgical evaluation of a woman's ovarian mass for cancer, is now available nationally through Quest Diagnostics, Inc., the world's leading cancer diagnostics provider.

From Quest Diagnostics 10 Mar 2010

Enigma Diagnostics opens new Regional HQ office in San Diego

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the opening of its new Regional HQ office in San Diego, CA and the appointment of Joel Centeno as VP Regulatory & Quality.

4 Mar 2010

Abbott enters into agreement with GSK to develop molecular diagnostic test for skin cancer treatment

Abbott announced today that it has entered into an agreement with GlaxoSmithKline (GSK) to develop a molecular diagnostic test intended for use as an aid in selecting patients who may benefit from a skin cancer treatment in development by GSK.

4 Mar 2010

Study results of new PCR technology that reports mutations associated with FXS announced

Asuragen, Inc. announced today the results of a collaborative study with scientists at the M.I.N.D. Institute at the University of California Davis evaluating a new PCR technology that reproducibly reports mutations associated with Fragile X syndrome (FXS).

2 Mar 2010

Rapid, multiplexed genotyping method to identify SNPs that affect warfarin dose developed

Researchers from the Ohio State University have developed a rapid, multiplexed genotyping method to identify the single nucleotide polymorphisms (SNPs) that affect warfarin dose. The related report by Yang et al, "Rapid Genotyping of SNPs Influencing Warfarin Drug Response by SELDI-TOF Mass Spectrometry," appears in the March 2010 issue of the Journal of Molecular Diagnostics.

26 Feb 2010

AutoGenomics awarded ISO 13485 certification for quality management system

AutoGenomics, a leader in providing automated, molecular testing solutions announced today that the organization has been awarded the ISO 13485 certification in recognition of its outstanding quality management system throughout the organization. TUV SUD America Inc. was the Certification Body.

18 Feb 2010

Single microRNA exhibits potential to forecast outcomes of MPM

Rosetta Genomics, Ltd., a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published online on February 16th, 2010, and are set to be published in the March 1st issue of the American Association for Cancer Research’s journal, Cancer Research.

18 Feb 2010

HPV DNA testing vital in identification of cervical cancer

Roche Molecular Systems, Inc. announced today that preliminary data from its ATHENA (Addressing THE Need for Advanced HPV Diagnostics) trial support the importance of screening for human papillomavirus (HPV) genotypes that put women at highest risk for developing cervical cancer. ATHENA is a prospective, double-blind, multi-centered, 47,000-patient, U.S.-registration trial designed to demonstrate the effectiveness of HPV detection as part of a cervical cancer screening program.

18 Feb 2010

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

Roche Molecular Systems, Inc. announced today a research collaboration with Merck Sharp & Dohme Corp. (a subsidiary of Merck & Co., Inc.) providing Merck access to Roche's developmental microarray-based AmpliChip p53 Test, which is designed to detect mutations in the tumor suppressor gene p53. By identifying cancers that harbor a dysfunctional p53 gene, the companies aim to achieve better treatment outcomes in cancer patients by determining which patients are most likely to respond to certain investigational therapeutic candidates.

18 Feb 2010

Exagen Diagnostics, EndoChoice announce agreement for promoting diagnostic services to U.S. gastroenterologists

Exagen Diagnostics, Inc., a molecular diagnostics laboratory that discovers, develops and markets proprietary genomic tests, today announced an exclusive sales and marketing agreement with EndoChoice, Inc. to promote its diagnostic services to gastroenterologists throughout the United States.

17 Feb 2010

Sequenom CMM launches SensiGene Fetal Sex Determination test

Sequenom, Inc. today announced the launch of the SensiGene™ Fetal(XY) (Fetal Sex Determination) test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's second laboratory developed test powered by its SEQureDx™ technology.

17 Feb 2010

Three Dutch life-science sectors announce joint investment to research on personalized medicine

The Netherlands' three Top Institutes for life-science research (the BioMedical Materials program, the Center for Translational Molecular Medicine and Top Institute Pharma) today announced a joint investment of MEUR 28 on innovative research targeted at bringing personalized medicine closer to reality.

16 Feb 2010

Fourth-quarter and full-year 2009 results announced by Quidel

Quidel Corporation, a leading provider of rapid point-of-care diagnostic tests, announced today financial results for the fourth quarter and full year ended December 31, 2009.

12 Feb 2010

Tecan Group, Enigma Diagnostics sign manufacturing and supply agreement for Enigma ML instruments

The Tecan Group, a leading global provider of laboratory instruments and solutions, and Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the signing of a manufacturing and supply agreement for Enigma's ML instruments.

From Tecan 5 Feb 2010

Molecular Diagnostics News and Research

Clinical Reference Laboratory completes validation testing of DNA Genotek's Oragene-DNA saliva collection kits

Meridian Bioscience seeks FDA marketing clearance for illumigene C. difficile molecular diagnostic test

Asuragen appoints BMD as exclusive distributor of Signature Oncology Products in France

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Roche Diagnostics named sole source supplier for Premier's blood glucose monitoring devices

NeoMed invests in CytoCore

OVA1 blood test aids in pre-surgical evaluation of women for ovarian cancer now available through Quest Diagnostics

Enigma Diagnostics opens new Regional HQ office in San Diego

Abbott enters into agreement with GSK to develop molecular diagnostic test for skin cancer treatment

Study results of new PCR technology that reports mutations associated with FXS announced

Rapid, multiplexed genotyping method to identify SNPs that affect warfarin dose developed

AutoGenomics awarded ISO 13485 certification for quality management system

Single microRNA exhibits potential to forecast outcomes of MPM

HPV DNA testing vital in identification of cervical cancer

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

Exagen Diagnostics, EndoChoice announce agreement for promoting diagnostic services to U.S. gastroenterologists

Sequenom CMM launches SensiGene Fetal Sex Determination test

Three Dutch life-science sectors announce joint investment to research on personalized medicine

Fourth-quarter and full-year 2009 results announced by Quidel

Tecan Group, Enigma Diagnostics sign manufacturing and supply agreement for Enigma ML instruments

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