The Food and Drug Administration plans to approve a Maryland-based company's highly specific test for the human papilloma virus, which is associated with an increased risk of cervical cancer, for marketing in the United States.
A spokeswoman for the FDA Center for Devices and Radiological Health, the arm that regulates medical devices and diagnostics, said yesterday that Gaithersburg-based Oncor Inc. was notified in a May 13 letter that its test merited approval subject to final labeling and inspection requirements.
Assuming Oncor's test does win final approval, it would compete with just one other test for the same virus. The competitor is made and marketed by another Maryland company, Digene Corp., based in Silver Spring.
The Digene test, according to the FDA, can determine the presence of more strains of the virus than the Oncor test, but cannot tell exactly which strain is present. Oncor's test is specific for seven different strains.
There are about 80 strains of the sexually transmitted virus, and about 15 are linked to cervical cancer. Oncor said data from its clinical trials showed that its test detects 90 percent of the HPVs found in cervical cancers.
If the Oncor test is approved, it would be the third cancer-related Oncor testapproved for marketing in the United States.
The publicly held company, which reported a net loss of $18.2 million last year, already markets two different tests for de- tecting rearrangements in different types of white blood cells, known as B-cells and T-cells. These rearrangements are indicators for leukemia and lymphatic cancer. The HPV test would be marketed to medical laboratories that test for cervical cancer, said Dr. Stephen Turner, Oncor's chief executive officer, and would be used as a follow-up to abnormal Pap smears.
A new cell specimen would be needed from women whose Pap smears were suspicious. About 5 percent, or 2.45 million, of the 49 million Pap smears conducted in the United States annually show an abnormality.
Oncor said its HPV kit, which took about three years to develop, can simultaneously identify the presence of the papilloma virus in a patient and can distinguish among seven specific types of HPV that are considered to indicate a high risk of the viral disease progressing to cancer.
"The combination of the abnormal Pap smear and detection of a specific strain of HPV would give the physician a good reason to watch a patient a lot more closely," Turner said.
The executive said Oncor intends to market the test, if approved, through its own sales force and through marketing agreements with companies involved in the cervical cancer and cancer screening markets.
Turner declined to estimate what the HPV test might generate in revenues annually, but said the company expects the HPV test to cost patients about $25.
He said the company would be ready to begin shipment of the HPV test kits soon after final approval is received from the FDA.
"It's a nice step forward for us," Turner said.
Oncor's stock lost 6 1/4 cents to close at $6.4375 yesterday.
Pub Date: 5/21/96