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In Vitro Diagnostics News

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Myriad receives favorable medicare final coverage decision for Prolaris test
By MDBR Staff Writer
Myriad Genetics announced that Noridian, the Medicare Administrative Contractor (MAC) for Myriad, has issued a final local coverage determination (LCD) for Prolaris, Myriad's pioneering prognostic test for assessing the aggressiveness of prostate cancer.
Diagnostics > In Vitro Diagnostics > News
ABR launches bovine polyomavirus testing service
By MDBR Staff Writer
ABR (now a VMRD division) announced the availability of a new testing service that can detect the presence of bovine polyomavirus (BPyV) in animal origin products, master virus seeds, and other sample types.
Diagnostics > In Vitro Diagnostics > News
Provista completes enrollment in biomarker assay’s second cohort to detect breast cancer
By MDBR Staff Writer
Molecular diagnostics firm Provista Diagnostics has completed the enrollment of patients in the second cohort of a prospective study of its protein-based biomarker blood test to detect breast cancer.
Diagnostics > In Vitro Diagnostics > News
Roche to buy in vitro diagnostics firm GeneWEAVE for $425m
By MDBR Staff Writer
Switzerland’s Roche has entered into an agreement to acquire US-based in vitro diagnostics firm GeneWEAVE BioSciences for around $425m.
Diagnostics > In Vitro Diagnostics > News
NOWDiagnostics obtains FDA 510(k) approval for ADEXUSDx test
By MDBR Staff Writer
NOWDiagnostics has received 510(k) approval from the US Food and Drug Administration (FDA) for its ADEXUSDx hCG point-of-care test, which allows health care professionals in an early detection of pregnancy in different clinical and critical care settings.
Diagnostics > In Vitro Diagnostics > News
Instrumentation Laboratory launches HemosIL Rivaroxaban Testing Solution in Europe
By MDBR Staff Writer
Instrumentation Laboratory (IL) announced the commercialization of their HemosIL Rivaroxaban Testing Solution in Europe.
Diagnostics > In Vitro Diagnostics > News
UK researchers develop new urine test to identify early stage pancreatic cancer
By MDBR Staff Writer
Researchers from Barts Cancer Institute (BCI) in the UK have developed a new urine test that will help in the detection of early stage pancreatic cancer.
Diagnostics > In Vitro Diagnostics > News
Exalenz to use BreathID test in GR-MD-02 trial of NASH Cirrhosis
By MDBR Staff Writer
Exalenz Bioscience has partnered with Galectin Therapeutics to use its BreathID test to monitor patients in a Phase II study assessing GR-MD-02, which is an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis).
Diagnostics > In Vitro Diagnostics > News
Urology Practice publishes study showing Oncotype DX increases use of active surveillance in prostate cancer patients by 56%
By MDBR Staff Writer
Genomic Health announced that Urology Practice published results from the second clinical utility study of the Oncotype DX prostate cancer test, showing that incorporation of the test's Genomic Prostate Score (GPS) in treatment planning resulted in greater recommendations and acceptance of active surveillance as initial management of prostate cancer in low and low-intermediate risk patients.
Diagnostics > In Vitro Diagnostics > News
Roche seeks FDA approval for cobas EGFR Mutation Test v2
By MDBR Staff Writer
Roche is seeking approval from the US Food and Drug Administration (FDA) for its cobas EGFR Mutation Test v2.
Diagnostics > In Vitro Diagnostics > News
Rosetta Genomics expands molecular diagnostic offering with launch of OncoGxSelect
By MDBR Staff Writer
Rosetta Genomics, a leading developer and provider of microRNA-based molecular diagnostics, today announced that OncoGxSelect, Admera Health’s latest next-generation sequencing (NGS) oncology panel, has been approved for clinical use by The New Jersey Department of Health (NJDH).
Diagnostics > In Vitro Diagnostics > News
Marker Test Diagnostics secures second agreement to distribute UR Code product
By MDBR Staff Writer
Marker Test Diagnostics, a leading international supplier to the drug testing industry, has secured its second agreement to distribute its UR Code urine marker product in the US with PSO Laboratory, a leading provider of drug confirmation testing and toxicology services in Michigan.
Diagnostics > In Vitro Diagnostics > News
Cepheid introduces new portable molecular diagnostics system GeneXpert Omni
By MDBR Staff Writer
US-based molecular diagnostics firm Cepheid, along with FIND, has introduced a new portable molecular diagnostics system GeneXpert Omni that will help in patient diagnosis suspected of TB, HIV and Ebola.
Diagnostics > In Vitro Diagnostics > News
Thermo Fisher Scientific introduces new instruments and assays at AACC 2015
By MDBR Staff Writer
Thermo Fisher Scientific has launched new instruments and assays at the 2015 AACC Annual Meeting and Clinical Lab Expo in Atlanta, which is being held from 26 to 30 July.
Diagnostics > In Vitro Diagnostics > News
SeraCare, ViveBio partner to provide preanalytic products for IVD industry
By MDBR Staff Writer
SeraCare Life Sciences has entered into a strategic agreement with biotechnology firm ViveBio to jointly market and sell their combined technologies into the in vitro diagnostic (IVD) development market.
Diagnostics > In Vitro Diagnostics > News
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