Cholestech to work with Boule on blood test for doctors' offices

New York, Nov. 17 - Cholestech Corp. said it has signed an agreement with Boule Diagnostic International to develop and distribute a Complete Blood Count test system designed for waiver under the federal government's Clinical Laboratory Improvement Amendments.

There are no Clinical Laboratory Improvement Amendments-waived systems in use in the United States and Cholestech could be first, the company said.

The two companies will collaborate on development and Cholestech will receive exclusive distribution rights covering all human applications in the United States and Canada.

Cholestech will pay $2.5 million on signing, $0.5 million on Food and Drug Administration 510(k) clearance and $1.0 million upon receipt of a waiver.

Sales are expected to start in 2007.

Complete Blood Count tests were conducted for 89 million physician office visits in the United States, more than any other laboratory test. Reimbursement for an in-office test is in place at $11 per test.

Currently, Complete Blood Count testing is performed using large, costly analyzers which are well-suited to commercial reference and hospital laboratories capable of running large volumes of moderate complexity tests but poorly suited to typical physician practices.

Cholestech is a Hayward, Calif., manufacturer of point-of-care testing systems. Boule Diagnostic International is a manufacturer of hematology systems, headquartered in Stockholm, Sweden.

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