BioSante Pharmaceuticals, Inc. (BPAX)

[jadite]

Excerpt from 2010 article emphasizing need for testing and that current testing sucks:

http://www.aacc.org/publications/cln/2010/august/Pages/CoverStory1.aspx


"Representatives from both Abbott Diagnostics and Beckman Coulter agreed that manufacturers have a crucial role in improving testosterone assays. “Clinical laboratories look to diagnostic manufacturers to provide reagents and instrumentation which lead to the best and most accurate results for medical diagnostics,” said Linda C. Rogers, PhD, DABCC, FACB, manager of market development for Beckman Coulter. In the end, “physicians need to be able to trust low concentration testosterone measurements. However, current research shows that immunoassays in the lower ranges are no better than random number generators,” added Stuart Blincko, PhD, principal research scientist at Abbott Diagnostics.

Rogers indicated that Beckman Coulter has conducted feasibility studies to evaluate the development of a highly sensitive testosterone assay, while Blincko stated that Abbott is developing a direct immunoassay that will measure both low and high testosterone concentrations. The latter will be designed to align with the method listed in the Joint Committee for Traceability in Laboratory Medicine. Abbott does not plan to pursue a direct pediatric claim for this new assay, according to Blincko."

BPAX/ABT/FDA might really be saying "let's not have the cart before the horse".