Hybritech’s Test Devices Win U.S. OK : New Products Used in Diagnosis of Cancer, Pregnancy

Maintaining its campaign to secure a portion of the $25-million-per-year diagnostic market now controlled by arch-competitor Abbott Laboratories, Hybritech Inc. n Monday said it had received federal approval to market new tests for cancer and pregnancy.

Tandem-E CEA Immunometric Assay is Hybritech’s second product that uses monoclonal antibodies--or disease-fighting proteins--to detect and measure CEA, or carcinoembryonic antigen, in blood serum samples that has received Food and Drug Administration approval.

In January, the FDA approved the Tandem-R test kit. The difference between the two is that the Tandem-E is an “enzyme product that lasts six months on the shelf instead of two months,” like the Tandem-R, according to Cam Garner, Hybritech’s vice president of sales and marketing.

“Customers are demanding” the longer shelf life, said Garner, adding that Hybritech has started shipping the test kits to laboratories and hospitals around the country.

The kits measure the CEA typically found in patients with cancer of the colon, rectum, breast or lung.

Hybritech also said Monday that it had received FDA approval for its second rapid pregnancy test using a process that does not rely on instruments.

Hybritech’s bid to compete with Abbott Laboratories has been a tough battle. Abbott controls about 77% of the diagnostic devices market.