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Court Ruling Opens Up Breast Cancer Diagnostics

San Diego genetics testing company Pathway Genomics Inc. announced it will begin offering more affordable genetic testing for breast and ovarian cancers.

This comes in the wake of the recent Supreme Court ruling that companies can’t patent naturally occurring portions of human DNA — but can, however, patent synthetic strands of DNA.

The ruling found that Salt Lake City-based Myriad Genetics Inc. could not patent natural genetic mutations found to increase risk of breast and ovarian cancer. Myriad was challenged by a group of scientists, which eventually led to the case reaching the high court — despite the fact that the U.S. Patent and Trademark Office has permitted the patenting of human genes for nearly 30 years.

Because of the patent, Myriad held a monopoly on conducting these breast and ovarian cancer-screening tests, said Pathway CEO Jim Plante.

“This ruling will have a huge impact on biotech as a whole — every lab that has the capability like Pathway to run diagnostic tests for breast cancer will now obviously be able to enter the market,” Plante said. “I think it’s a good thing for patients, of course, to expand the accessibility of these tests at a lower price point than before.”

It will launch a series of cancer-based tests this August, and will include the BRCA gene testing in its offerings. It’s been widely reported that Myriad Genetics was charging between $3,000 and $7,000 for the tests.

Affordable Genetic Testing

“We’re not disclosing the price yet, but we will when we get closer to launch,” Plante said.

With an estimated 40,000 people expected to die of breast cancer this year, Pathway said it thinks the effects of providing affordable genetics testing will be profound.

Pathway has long offered genomics testing, offering diagnostic and predictive testing for hundreds of diseases and medications across a vast swath of specialties — cardiology, fertility, psychiatry and pain management.

The privately held company, founded in 2008, conducts its DNA testing by analyzing a person’s saliva, at Pathway’s Sorrento Valley laboratory.

Plante said the company has been working on the forthcoming Hereditary Cancer DNA Insight test, and began developing a test for the BRCA1 and BRCA2 gene since early last year.

“This is why we’re able to get to market in August,” Plante said. “If the Supreme Court didn’t overturn those patents, then we would have launched our oncology tests without breast cancer.”

The test series will also screen for 30 genes linked to inherited cancers, including thyroid, lung and colorectal cancers.

Other diagnostics companies across the country stepped up and announced they’d make breast cancer genetic screening tests widely available. This includes Gaithersburg, Md.-based Bio-Reference Laboratories Inc.’s subsidiary GeneDX; Aliso Viejo, Calif.-based Ambry Genetics Inc.; and Madison, N.J.-based testing giant Quest Diagnostics Inc.

“As the leader in women’s health and cancer diagnostics, we are very interested in offering a BRCA testing service,” said Wendy Bost, a spokeswoman for Quest Diagnostics, in an email. “We now intend to validate and offer a BRCA1 and BRCA2 test service to physicians and patients later this year.”

Following the Supreme Court announcement, the decision was lauded by a host of San Diego biotechs participating in this year’s CalBio conference downtown.

‘Positive Decision’ for the Industry

“I think it sort of reaffirms very nicely the assumptions that all of us are operating on as the right way to proceed,” J. Craig Venter, a San Diego biologist and entrepreneur who was heavily involved in the Human Genome Project, said in his keynote speech. “I think it’s a very positive decision for the biotech industry.”

Plante agreed that, his company aside, the Supreme Court ruling had positive implications on the biotech industry and said it could encourage more funding to come into the genetic diagnostics space.

“Obviously, it’s hard to get your products into the market if you’re afraid that they infringe on different patents, and you halt any progress you might have made in that field,” Plante said. “And that’s exactly what we saw happen — the BRCA1 patent really held back the technical progress for that particular disease. But now, as an industry we can move forward.”

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