07:00 , Aug 11, 2014 |  BioCentury  |  Regulation

LDT blurred Lines

FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align...
07:00 , Jun 8, 2009 |  BC Week In Review  |  Company News

BioGenex, Abbott sales and marketing update

The partners extended by multiple years a 2004 deal to co-exclusively market and distribute Xmatrx, a system that automates diagnostics based on Abbott's FISH technology. Under the terms of the agreement, Abbott customers will continue...
07:00 , Sep 11, 2006 |  BC Week In Review  |  Company News

BioGenex Inc. board of directors update

BioGenex Inc. , San Ramon, Calif.   Business: Supply/Service   Appointed: Raymond Cohen, CEO of Symphony Medical Inc.  ...
08:00 , Feb 7, 2005 |  BC Week In Review  |  Clinical News

InSite HER2/neu Kit regulatory update

FDA approved a PMA for BioGenex's InSite HER2/neu Kit an in vitro diagnostic kit to identify breast cancer patients eligible for Herceptin trastuzumab treatment. The automated format of the kit is approved for use on...
07:00 , Oct 25, 2004 |  BC Week In Review  |  Company News

Abbott, BioGenex sales and marketing update

ABT and BioGenex will co-exclusively market and distribute a system that automates diagnostics based on ABT's FISH technology. ABT has made an upfront payment to BioGenex and agreed to a multiyear minimum purchase commitment. Separately,...
07:00 , Aug 9, 2004 |  BC Week In Review  |  Company News

BioGenex sales and marketing update

BioGenex launched its EZ Retrieval System for antigen retrieval from formalin-fixed, paraffin-embedded tissue sections. BioGenex Laboratories Inc. , San Ramon, Calif.   Business: Supply/service  ...
07:00 , Aug 27, 2001 |  BC Week In Review  |  Company News

BioGenex sales and marketing update

BioGenex launched its GenoMx series of instruments for high throughput automated cell and tissue staining. The system, which allows gene expression profiling, includes a bar-code labeling system, sample preparation, slide staining and image analysis components....
07:00 , Sep 7, 1999 |  BC Week In Review  |  Clinical News

Multifunctional reagents regulatory update

BioGenex received U.S. Patent No. 5,916,750 covering the use of multifunctional linking reagents for the synthesis of branched oligomers to introduce multiple labels or reporter molecules onto oligomers such as oligonucleotides and oligopeptides. BioGenex Laboratories...
07:00 , Apr 13, 1998 |  BC Week In Review  |  Company News

BioGenex, BioTek Solutions Inc. cancer, diagnostics/imaging news

BioGenex said that the U.S. Court of Appeals for the Federal Circuit upheld a July 1997 order by the U.S. District Court for Northern California. The order awarded BioGenex $840,000 in damages in its suit...
07:00 , Jul 28, 1997 |  BC Week In Review  |  Company News

BioGenex, Kyowa-Medex Co. Ltd. deal

Kyowa-Medex will distribute to Japanese hospitals and academic labs BioGenex's immunohistochemistry product line of antibodies and detection reagents used for tumor diagnostic tests. Kyowa-Medex also will non-exclusively distribute BioGenix's automated immunohistochemistry instrumentation. BioGenex will receive...