The landmark ruling by the U.S. Supreme Court earlier this month on the right of businesses to patent human genes has continued to prompt laboratories to wade into the molecular breast cancer testing market. The high court invalidated the patents Myriad Genetics had held on the BRCA1 and BRCA2 genes, ruling that unaltered genetic material could not be patented (LIR, June 20, 2013, p. 1). It allowed Myriad to essentially hold the entire molecular testing market for genetic markers for breast cancer. Altered genetic material could still be patented, however. Within hours of the court’s ruling, at least three laboratories—including the nation’s largest laboratory, Quest Diagnostics—announced that they would be offering BRCA testing, and others chimed in during the days after. San Diego-based Pathway Genomics announced two days after the Supreme Court ruling it would offer the BRCA1 and BRCA2 tests as part of a genetic cancer panel it will release in August. It did not announce the price but said in a statement that it would be “substantially lower than the competition.” Ambry Genetics, another San Diego-area laboratory, said it would also offer BRCA testing as part of a $2,200 panel of gene-based cancer testing. “The relationship between BRCA1/2 […]
The landmark ruling by the U.S. Supreme Court earlier this month on the right of businesses to patent human genes has continued to prompt laboratories to wade into the molecular breast cancer testing market.
The high court invalidated the patents Myriad Genetics had held on the BRCA1 and BRCA2 genes, ruling that unaltered genetic material could not be patented (LIR, June 20, 2013, p. 1). It allowed Myriad to essentially hold the entire molecular testing market for genetic markers for breast cancer. Altered genetic material could still be patented, however.
Within hours of the court’s ruling, at least three laboratories—including the nation’s largest laboratory, Quest Diagnostics—announced that they would be offering BRCA testing, and others chimed in during the days after.
San Diego-based Pathway Genomics announced two days after the Supreme Court ruling it would offer the BRCA1 and BRCA2 tests as part of a genetic cancer panel it will release in August. It did not announce the price but said in a statement that it would be “substantially lower than the competition.”
Ambry Genetics, another San Diego-area laboratory, said it would also offer BRCA testing as part of a $2,200 panel of gene-based cancer testing.
“The relationship between BRCA1/2 and breast cancer risk was not discovered by a single patent holder, it stood on the shoulders of years of work by our scientific colleagues,” said Elizabeth Chao, M.D., Ambry’s chief medical officer. “This provides us with a strong basis for a variant classification program that will be second to none.”
GeneDx, a subsidiary of Bio-Reference Laboratories (Elmwood Park, N.J.), and DNATraits, an affiliate of Gene By Gene (Houston), also announced they would offer BRCA testing within hours of the Supreme Court decision.
Although LabCorp has yet to announce whether it will offer the BRCA testing, Darren Lehrich, a managing director with Deutsche, suggested in a recent analyst note that it was a possibility.
Lehrich noted that given Quest and LabCorp each have about a 10 percent to 12 percent market share of the laboratory business nationwide, BRCA testing for both of them could eventually add one-half to 1 percent of revenue growth “if their national market shares were commensurate in this arena.”
