Myriad Genetics, American Civil Liberties Union (ACLU) diagnostic news

The U.S. Supreme Court unanimously ruled that isolated DNA cannot be patented but cDNA can be patented. The decision is consistent with recommendations submitted by the Department of Justice in the case, Association for Molecular Pathology, et al. v. U.S. PTO, et al. (see BioCentury, April 22).

Both sides declared victory in the case, in which the ACLU litigated against claims in U.S. patents from Myriad Genetics covering breast cancer 1 early onset (BRCA1) and BRCA2 tests. The ACLU said that as a result of the ruling, "patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued." At least two companies - Ambry Genetics Corp. (Aliso Viejo, Calif.) and Gene By Gene Ltd. (Houston, Texas) - announced that they are offering BRCA1 and BRCA2 tests based on gene sequencing technology. Prior to the ruling, Gene By Gene had offered its test only to patients outside the U.S. ...