|
Article Excerpt
OraSure Technologies, Inc. (NASDAQ: OSUR), Bethlehem, Penn., has submitted a pre-market approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for a rapid test for antibodies to the Hepatitis C virus ("HCV") utilizing OraSure Technologies' OraQuickR technology platform. When approved, the OraQuickR HCV test is expected to be the first rapid HCV test approved by the FDA for use in the United States.
The company is seeking FDA approval for use of its OraQuickR HCV test on five specimen types - oral fluid, fingerstick whole blood, venous whole blood, plasma and serum. The submission reflects the successful completion of clinical studies which include data from over 3,000...
|
|
More articles from Biotech Business
ROCKWELL MEDICAL ANNOUNCES UPDATED DSMB RESULTS.(Financial report), December 01, 2008
Looking for additional articles?
Search our database of over 3 million articles.
Looking for more in-depth information on this industry?
Search our complete database of Industry & Market reports by text, subject, publication
name or publication date.
About Goliath
Whether you're looking for sales prospects, competitive information, company
analysis or best practices in managing your organization,
Goliath can help you meet your business needs.
Our extensive business information databases empower business
professionals with both the breadth and depth of credible,
authoritative information they need to support their business
goals. Whether it be strategic planning, sales prospecting,
company research or defining management best practices -
Goliath is your leading source for accurate information.
|
|
