This article was originally published in The Gray Sheet
Point-of-care oral fluid opiate detector test system gains 510(k) clearance on April 5. Development of a five-panel oral fluid assay for cocaine, methamphetamine/amphetamine, PCP and marijuana is ongoing; OraSure plans to submit a 510(k) for the indication by mid-summer ("1The Gray Sheet" Jan. 28, 2002, p. 4)...
You may also be interested in...
OraSure Technologies expects FDA approvals of its UPlink drugs-of-abuse test and OraQuick rapid HIV assay to help the firm reach profitability this year and grow revenues 30% over 2001
Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.