Hybritech Cancer-Testing Product OKd

SAN DIEGO — Hybritech Inc. received federal approval Wednesday for a cancer-testing product that will thrust the firm into a $25-million-per-year diagnostic market now controlled by Abbott Laboratories, which Hybritech accused last week of unfair competitive practices.

Hybritech’s Tandem-R CEA diagnostic kit measures CEA, or carcinoembryonic antigen, which is typically found in patients with cancer of the colon, rectum, breast or lung.

The product, approved by the Food and Drug Administration, is now being shipped to hospitals and laboratories, according to spokesman Bob Anacone.

Two similar diagnostic devices are already on the market. Chicago-based Abbott Laboratories controls about 77% of that industry segment, with a Hoffman-La Roche subsidiary, Roche Diagnostic Systems Inc., holding the rest, according to International Market Survey, a polling organization.

Hybritech last week filed an antitrust lawsuit in U.S. District Court in Los Angeles accusing Abbott Labs of plotting a strategy that would “have the maximum negative impact on Hybritech’s sales and profits with the least cost to Abbott.” The suit alleged that Abbott has attempted to discredit Hybritech’s products.

Abbott would not comment on the suit.

The new Hybritech product analyzes CEA levels in three hours, slightly longer than the time required by Abbott’s product, according to Anacone.

Hybritech’s product uses monoclonal antibodies, which are disease-fighting proteins.

They are produced by fusing an antibody-producing cell with a cancerous cell, presumably without destroying the healthy cell.