BC Innovations | Mar 31, 2017
Targets & Mechanisms

Cells on the rise

This year’s meeting of the American Association for Cancer Research (AACR) will keep the spotlight on immuno-oncology, where preclinical science is continuing to expand the use of different types of innate and adaptive immune cells...
BioCentury | Dec 14, 2015
Product Development

Risk-benefit litmus test

Beloranib's role in two deaths with concurrent thrombotic events will be difficult to elucidate in a condition whose biology is not well understood. However, if Zafgen Inc. can characterize and mitigate the risk through an...
BC Week In Review | Jun 23, 2014
Clinical News

Impact Dx Factor V Leiden and Factor II Genotyping Test regulatory update

Sequenom said FDA granted 510(k) clearance to the Impact Dx Factor V Leiden and Factor II Genotyping Test for use as an aid in diagnosing patients with suspected thrombophilia and to its Impact Dx System...
BC Week In Review | Oct 7, 2013
Clinical News

Impact Dx Factor V Leiden and Factor II Genotyping Test regulatory update

Sequenom submitted 510(k) applications to FDA for the Impact Dx Factor V Leiden and Factor II Genotyping Test as an aid in the diagnosis of patients with suspected thrombophilia and its Impact Dx System . The...
BC Week In Review | May 24, 2010
Clinical News

VeraCode Genotyping Test for Factor V regulatory update

FDA granted 510(k) clearance for Illumina's VeraCode Genotyping Test for Factor II (Prothrombin) and Factor V (Leiden), genetic markers associated with thrombosis. The test, which combines Illumina's VeraCode digital microbead technology and assay chemistry, runs...
BC Week In Review | May 3, 2010
Clinical News

ESensor Thrombophilia Risk Test regulatory update

FDA granted 510(k) clearance for Osmetech's eSensor Thrombophilia Risk Test to screen for 4 genetic markers associated with thrombosis, including Factor V Leiden, Factor II Prothrombin, MTHFR 677 and MTHFR 1298. The test was designed...
BC Innovations | Nov 19, 2009
Targets & Mechanisms

APC mutants for ALS

A study by University of Rochester researchers suggests that a modified form of activated protein C could be used to treat a common form of familial amyotrophic lateral sclerosis. 1 The findings also suggest that...
BC Week In Review | Oct 5, 2009
Clinical News

Xpert HemosIL Fll and FV Assay regulatory update

FDA granted 510(k) clearance for Cepheid's Xpert HemosIL FII & FV test to detect Factor II and Factor V Leiden genetic variations associated with thrombophilia. Instrumentation Laboratory , which has exclusive, worldwide marketing rights to the...
BC Extra | Jun 17, 2009
Clinical News

AHRQ questions value of genetic testing for DVT

A report by HHS's Agency for Healthcare Research and Quality said that there is no direct evidence to conclude that genetic testing for two gene mutations -- Factor V Leiden ( FVL ) and prothrombin G20210A --...
BC Week In Review | Jun 8, 2009
Clinical News

Xpert HemosIL Fll and FV Assay regulatory update

Health Canada granted a medical device license for Cepheid's Xpert HemosIL FII and FV test to detect Factor II and Factor V Leiden genetic variations associated with thrombophilia. The molecular diagnostic test runs on Cepheid's...
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