המידע באדיבות מדיקונטקסט
Last Updated: 2001-07-09 17:00:18 EDT (Reuters Health)
NEW YORK (Reuters Health) – Roche Diagnostics announced on Monday that it has received US Food and Drug Administration (FDA) approval for its Amplicor hepatitis C test, the first and only approved hepatitis C test that directly screens for the disease's viral RNA.
The approval also covers an automated version of the test, the Cobas Amplicor.
David Thomas, vice president of clinical and regulatory affairs at Roche Diagnostics, explained during a Monday conference call that the tests use polymerase chain reaction (PCR) technology to detect the genetic material of the virus in blood samples.
However, the Amplicor test is not meant to replace antibody tests, Dr. Michael Fried, director of clinical hepatology at the University of North Carolina at Chapel Hill, noted during the conference.
"[The Amplicor] test is actually a supplemental assay," he said. "The antibody test still remains the best screening test if you think your patient may have hepatitis C. However, the follow-up to that, to see if the disease is still active…would be to use a PCR test."
"To date, the Amplicor test has only been available in the research setting in the US," Thomas said. "Now, a large number of patients will have access to [the test] through their physicians. The test will be the only commercial qualitative test available to the general public through hospitals and licensed laboratories."
The Amplicor hepatitis C test platform is already approved in Europe and Asia.
-New York Newsroom 212 273 1700