OncorMed Inc. expanded the availability of its BRCA1 genetictesting service when its institutional review board approved a clinicaltesting protocol. Some believe, however, that OncorMed will have todiscontinue the service altogether next year.

The Gaithersburg, Md., company has been offering the test sincemid-1995, but only to patients of physicians who had access toapproved clinical programs. Now physicians in areas withoutapproved programs can offer the test to patients under the OncorMedprotocol.

The OncorMed protocol is designed to ensure that high-risk patientsare correctly identified, have access to the service and are counseledon the risks, benefits and limitations of the evaluation.

Timothy Triche, chairman and CEO of OncorMed, said, "As the onlycompany currently providing genetic evaluation of inherited breast-ovarian cancer on a commercial basis, we feel that it is important tobe able to offer broad access to this service without compromisingour high medical standards or commitment to patient protection."

The company, however, won't be the only one offering the testingservice for long. Myriad Genetics Inc. is expected to have its BRCA1diagnostic test available later this year. Myriad researchers andcollaborators discovered BRCA1, and have filed patent applications.

It likely will be 1997 at the earliest when a patent is issued and untilthen Myriad can exclude no one from offering the service. It still isunclear, however, how strong Myriad's position will be even afterpatent issues.

For example, OncorMed two weeks ago filed a patent on what itdescribed as a previously unidentified BRCA1 mutation. Whether amutation can be patented independent of the gene will be anotherissue for patent office officials to decide.

Matt Murray, an analyst who follows Myriad for New York-basedUBS Securities, said, "BRCA1 patents will issue to Myriad by thethird quarter of 1997, which will allow the company to block allcompetitors from BRCA1 breast cancer predisposition testing."Furthermore, he said, any BRCA1 mutations would be covered underthat patent because of the obviousness clause.

Myriad also has filed for patents to the BRCA2 gene, anotherindicator of early onset familial disease. Its researchers appear to bethe first to discover and fully sequence the gene, meaning Myriadwould have all diagnostic rights to that gene. Eventually a test will bedeveloped incorporating both BRCA1 and BRCA2.

If Myriad does get patents on both genes, it could preclude cross-licensing arrangements by companies such as OncorMed.

OncorMed officials are restricted from discussing intellectualproperty issues surrounding BRCA1 because the company is underregistration for a 2.5 million share offering. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.