ChemTrak Inc. officials said FDA approval of a competing hometesting and counseling service for HIV is good news as they wait tohear from the agency about their premarket approval application(PMA).
ChemTrak, of Sunnyvale, Calif., filed a PMA for its home accessHIV test in February 1995, about five months after the filing byJohnson & Johnson unit Direct Access Diagnostics. Direct Access,which developed the Confide test in conjunction with Chiron Corp.,expects to roll it out soon in Texas and Florida and make it availablenationwide in early 1997.
Filing for approval after ChemTrak was privately held Home AccessMedical Systems, of Hoffman Estates, Ill. That is expected to be thethird test available in which patients can send blood samples taken athome and call in anonymously later for results.
ChemTrak Vice President Alene Holzman said the test is more of aservice than a product, which made its FDA review unique. She saidthe FDA in these cases looks at reference laboratories, computer andtelephone systems and the counseling aspect of the service.
Holzman said the ChemTrak product is essentially the same as theJohnson & Johnson test approved last week. She said ChemTrakplans to address different markets and market niches than Johnson &Johnson.
Chiron, of Emeryville, Calif., will get 50 percent of the pre-taxprofits on sales of Confide through its 10-year-old agreement withJohnson & Johnson. That agreement covers tests that use antibodiesto detect hepatitis and retroviruses. Last year Chiron's pre-tax profitfrom the arrangement was $77 million.
While still covered under the original agreement the joint businessbetween Chiron and Home Access is separate from the one Chironhas with Johnson & Johnson unit Ortho Diagnostic Systems Inc., ofRaritan, N.J. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.