Beckman Gets FDA’s OK for Prostate Cancer Test

Beckman Instruments Inc. said it won government clearance for its newest blood test to help detect prostate cancer.

The Food and Drug Administration approval comes just over a month after an advisory panel for the FDA recommended the agency approve the test, called the Hybritech Free PSA test.

“There is significant potential for this new test to save health care dollars and spare a substantial number of men from unnecessary biopsies,” said Paula Southwick, a spokeswoman for Hybritech Inc., the Beckman Instruments subsidiary that developed the new test.

The test is expected to reduce the number of unnecessary prostate biopsies by about 20%, the company said. Hybritech helps distinguish a prostate that is simply enlarged from one that is cancerous when screening results are inconclusive. Now, an often-uncomfortable biopsy generally must be done for confirmation in such cases.

The test is part of Beckman’s bid to claim the dominant position in the $200-million to $300-million prostate testing market from Abbott Laboratories, analysts said.

Beckman shares rose $1.63 to $51.63.

While the test is good news for men, health insurance companies and managed care plans because it will reduce the number of biopsies needed, it most likely will not generate substantial sales for Fullerton-based Beckman, analysts said. Instead, it will allow the company to offer laboratories, testing services and other customers an option that its competitors cannot.

Also, it will boost the company’s plan to provide comprehensive prostate cancer testing supplies and equipment, Scott Wilkin, an analyst at SBC Warburg Dillon Reed Inc., said at the panel hearing.