By Bradley J. Fikes
SAN DIEGO, CA – June 3, 2014 – Taking advantage of last year’s Supreme Court ruling against many gene patents, Pathway Genomics Corp. said Tuesday it has started selling a test to detect mutation in genes associated with breast cancer and other malignancies.
The test is ordered by doctors and performed in Pathway’s certified laboratory.
Pathway Genomics’ test spots aberrations in the “BRCA” genes known for heightened risk of breast and ovarian cancer. Mutations also increase the risk of prostate, breast and skin cancer in men.
Last year, actress Angelina Jolie underwent a double mastectomy after testing revealed she had a particularly dangerous BRCA mutation.
Jolie took the test because there is a history of cancer in her family. Jolie’s test was provided by Myriad Genetics, a Salt Lake City biotech which held a legal monopoly on the BRCA test until the Supreme Court ruling. That ruling said gene sequences existing in nature cannot be patented. It opened the way to competitors, now including San Diego’s Pathway Genomics.
Shortly after the court’s ruling on June 13, Pathway said it would enter the BRCA testing business. Another competitor, Ambry Genetics of Aliso Viejo, began offering the test on the day of the decision. In March, a federal judge rejected Myriad’s request for a preliminary injunction to stop Ambry’s service.
BRCA testing has been lucrative for Myriad. In years past, the company’s BRCA tests have brought in about 80 percent of its revenue. In the fiscal year ended June 30, Myriad took in overall revenue of $613 million.
Myriad charges nearly $4,000 for its test. Pathway Genomics is charging $1,800 for its BRCA True test, said Ardy Arianpour, the company’s chief strategy officer. Results are available in 14 calendar days, he said.
For people who don’t have health insurance or otherwise can’t afford the test, Pathway Genomics
said it’s donating up to $10 million in free testing. For every qualifying test ordered, one will be
donated, according to the company.
There are two BRCA genes, BRCA1 and BRCA2. Mutations in these genes have long been known to be associated with breast and ovarian cancer in women, and breast, prostate and skin cancer in men. A study released Sunday found a link between a BRCA2 mutation and increased risk of lung cancer in smokers. The risk is about 25 percent, nearly double the risk of smokers who don’t have the mutation.
Like Myriad’s test, Pathway’s BRCA True covers both BRCA genes. The Pathway test covers 18,000 base pairs, or “letters” of the DNA alphabet, Arianpour said.
However, Myriad said its database of significant BRCA mutations — which is not affected by the Supreme Court ruling — makes its testing more accurate than that of competitors. That’s because some mutations carry a higher risk of cancer than others. Myriad keeps the database confidential as a trade secret.