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News Breaks
July 31, 2014
11:29 EDTDGX, LH, BRLIFDA announces steps to ensure reliable diagnostic test results
The FDA announced that it took "important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results." The FDA issued a final guidance on the development, review and approval of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients, the agency said. These tests are commonly used to detect certain types of gene-based cancers. The FDA also is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests, which are designed, manufactured and used within a single laboratory. The agency also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements. Publicly traded laboratory companies include LabCorp (LH), Quest Diagnostics (DGX) and Bio-Reference Labs (BRLI). Reference Link
News For LH;DGX;BRLI From The Last 14 Days
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December 18, 2014
09:07 EDTLHLabCorp announces availability of test to identify enterovirus D-68
LabCorp announced the availability of a reflex test to identify enterovirus D68, which is associated with severe respiratory illness that primarily affects children. The EV-D68 PCR test determines the presence or absence of enteroviral RNA in a respiratory sample, and if positive, reflexes to an EV-D68-specific PCR test. The EV-D68 subtyping PCR test enables the presence or absence of the predominant D68 strain to be determined.
08:36 EDTBRLIBio-Reference Labs reports Q4 EPS 66c, consensus 63c
Reports Q4 revenue $227.59M, consensus $228.81M.
06:18 EDTDGXRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 16, 2014
08:46 EDTLHLabCorp, Covance announce expiration of Hart-Scott-Rodino waiting period
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December 15, 2014
10:10 EDTLHHigh option volume stocks:
High option volume stocks: RVBD AGCO FRO CRUS UBNT LH PAY PETM OREX KOS
December 10, 2014
09:46 EDTBRLIBio-Reference Labs mentioned cautiously by Geoinvesting
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December 9, 2014
15:31 EDTLHLabCorp management to meet with Craig-Hallum
Meeting to be held in Baltimore on December 10 hosted by Craig-Hallum.
07:44 EDTDGXAmerican Association for Cancer Research to hold a symposium
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