By Anand Basu
BANGALORE (Reuters) - OraSure Technologies Inc said it received U.S. regulatory approval to market a hepatitis C virus (HCV) test, OraQuick, sending its shares up 16 percent.
The approval of the device to detect HCV antibodies in unmodified blood specimen collected from the vein raises hopes of the test getting the nod for multiple specimen types such as oral fluid and fingerstick whole blood sample types.
"It is the first step of the approval process. The main market is going to be the oral fluid test," said Needham & Co analyst Sameer Harish.
Oral fluid test is usually preferred by patients over whole blood test as specimens can be collected easily and don't require blood samples.
Harish, who has a "buy" rating on OraSure shares, expects the FDA to approve the oral fluid HCV test this year.
OraSure already has one FDA approved HIV test, OraQuick Advance Rapid, in the U.S. market for detecting antibodies to HIV-1 and HIV-2.
Last year, the U.S. Food and Drug Administration declined to approve the company's HCV rapid antibody test OraQuick on concerns of potential bias in data interpretation.
In the United States there are about 4.1 million people, or 1.6 percent of the population, who have been infected with HCV, the company said.
The company, which has partnered with Merck & Co for the HCV test, said Merck will provide promotional support, including detailing the test in the physicians' office market.
Shares of the company were up 5 percent at $5.11 Friday afternoon on Nasdaq. They earlier touched a high of $5.63.
(Reporting by Anand Basu in Bangalore; Editing by Roshni Menon)