22:55 , Oct 18, 2017 |  BC Extra  |  Company News

Management tracks: Gilead, Ipsen, Depomed

Gilead Sciences Inc. (NASDAQ:GILD) promoted Alessandro Riva to EVP of oncology therapeutics. He was SVP of hematology and oncology therapeutic area head. Before joining Gilead this year, he was head of global oncology development at...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Financial News

IDbyDNA completes venture financing

IDbyDNA Inc. , San Francisco, Calif.   Business: Diagnostic   Date completed: 2016-09-08   Type: Venture financing   Raised: $9 million   Investors: Artis Ventures; ARUP Laboratories; private investors  ...
07:00 , Sep 8, 2016 |  BC Extra  |  Financial News

IDbyDNA raises $9M for diagnostic software

Infectious disease diagnostics developer IDbyDNA Inc. (Sunnyvale, Calif.) raised $9 million in a series A round led by Artis Ventures. Arup Laboratories (Salt Lake City, Utah) and other private investors also participated. IDbyDNA's Taxonomer metagenomics...
00:23 , Jul 18, 2014 |  BC Extra  |  Politics & Policy

Academic labs argue against FDA guidance on LDTs

A group of academic laboratories urged the White House Office of Management and Budget against the release of FDA draft guidance for regulating laboratory-developed diagnostic tests (LDTs). In a Arup Laboratories (Salt Lake City, Utah)...
07:00 , Jun 9, 2014 |  BC Week In Review  |  Clinical News

Epi proColon 2 regulatory update

Epigenomics said it received a response letter from FDA for a PMA for its Epi proColon 2.0 blood-based colorectal cancer (CRC) screening test. The company said FDA requested additional data demonstrating the test would increase...
07:00 , Apr 28, 2014 |  BC Week In Review  |  Clinical News

Epi proColon 2: Clinical trial data

A Chinese clinical validation trial in 1,074 patients showed that Epigenomics' Epi proColon 2.0 test had 74.8% sensitivity and 97.4% specificity for detecting colorectal cancer. Additionally, Epigenomics said partner BioChain Institute Inc. (Newark, Calif.) submitted...
07:00 , Mar 31, 2014 |  BC Week In Review  |  Clinical News

Epi proColon 2 regulatory update

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 5-4, with 1 abstention, that the benefits of colorectal cancer test Epi proColon 2.0 from Epigenomics outweigh the product's risks. Concerns about...
08:00 , Feb 10, 2014 |  BC Week In Review  |  Clinical News

Epi proColon 2 regulatory update

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee will meet on March 26 to discuss a PMA for Epi proColon 2.0 from Epigenomics for early detection of colorectal cancer. The product...
08:00 , Jan 6, 2014 |  BC Week In Review  |  Clinical News

Epi proColon regulatory update

Last month, French supplementary insurance provider Mutuelle d'Assurances du Corps de Sante Francais (MACSF) said it will provide Epi proColon for the early detection of colorectal cancer (CRC) as part of its additional health insurance...
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

Epi proColon 2 regulatory update

Epigenomics said FDA set a tentative date of March 25 for a meeting of the agency's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss a PMA for Epigenomics' Epi proColon...