OraSure HCV test gets FDA nod for promotional expansion...

OraSure's HCV test gets a boost thanks to an FDA nod to expand the promotion and use of the test, which will be co-marketed by Merck. The test is said to be able to determine HCV positivity within 20 minutes. The approval should also be a boon to both Merck, Vertex and near-term HCV DAA developers as this is an opportunity to expand the pool of treatable patients

OraSure gets wider use for hep C test, shares up

* Test can check for hepatitis C virus in 20 minutes

* OraSure shares up 8.8 percent

Nov 29 (Reuters) - OraSure Technologies received approval to sell its test for the hepatitis C virus to a wider range of clinics and doctors' offices in the United States, sending shares of the company up nearly 9 percent.

The company said on Tuesday the Food and Drug Administration expanded approval for the OraQuick HCV test, allowing more than 180,000 facilities to use it for detecting the serious liver disease in patients.

The FDA approved the test in February, but initially limited its use to clinically trained staff.

The test for the virus can be done via blood samples taken from a vein, or with a finger-stick test, which draws a tiny amount of blood by pricking the finger.

OraSure, based in Bethlehem, Pennsylvania, said patients can get a diagnosis in 20 minutes.

About 4 million people in the United States, and 180 million worldwide, are infected with the hepatitis C virus, the company said. Untreated, hepatitis C can lead to chronic liver disease, liver cancer and the need for a liver transplant.

Infections with the hepatitis C virus are not generally obvious. In most cases there may be no symptoms for years while the hepatitis quietly damages the liver until it is finally diagnosed.

"New therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic," Dr. Willis Maddrey, president of the Chronic Liver Disease Foundation said in a statement provided by OraSure.

Vertex Pharmaceuticals and Merck & Co both received approval to market new hepatitis C drugs earlier this year. The market for such drugs is estimated to be worth about $15 billion by 2019, and both companies are conducting campaigns to raise awareness of the disease.

An increase in hepatitis C testing should help boost sales of the new medicines.

Merck will help promote the OraQuick HCV test in doctors' offices as part of a collaboration agreement, OraSure said.

OraSure shares closed up 69 cents, or 8.8 percent, to $8.55 on Nasdaq.

OraSure Technologies seeks to expand laboratory access to OraQuick(R) HCV Rapid Test

BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with venous whole blood and fingerstick whole blood specimens.

The OraQuick® HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus and is currently classified as a moderately complex test which can be used by approximately 40,000 laboratories certified as meeting certain quality and training requirements under CLIA. According to the Centers for Medicaid and Medicare Services, if the CLIA waiver application is approved, the OraQuick® HCV test could then be available for use by more than 180,000 sites nationwide, including those that can perform CLIA-waived tests such as outreach clinics, community-based organizations and physician offices.

"If approved, a CLIA waiver would enable greater access to a test that could play a vital role in identifying HCV infection in the United States," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Most importantly, the CLIA waiver will enable healthcare providers, those on the front lines of fighting this disease, to identify more individuals infected with hepatitis C and connect them to care and treatment."

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.