Pathway Genomics launches liquid biopsy test for early cancer screening

Pathway Genomics CEO Jim Plante

As the direct-to-consumer testing craze reaches new heights, Pathway Genomics is rolling out a liquid biopsy test for early detection of cancer in otherwise healthy patients.

The San Diego, CA-based company's CancerIntercept product screens for 96 frequently occurring DNA mutations in 9 cancer genes, including those associated with lung, breast, ovarian and prostate cancers. Pathway plans to offer its product to consumers for $299, the company said in a statement, allowing individuals to check DNA in their blood for early warning signs of the disease. A doctor will order the test based on a patient's risk profile, and a positive test will require additional checks to find where the cancer is growing, Reuters reports.

"Early detection is the single most important factor in ensuring successful treatments and improved survival rates," Pathway CEO Jim Plante said in a statement. "Cancer patients and those at risk for the disease can take proactive steps to safeguard their health and fight back against some of the most virulent forms of the disease."

In addition to its liquid biopsy product, Pathway is also launching another tool that monitors cancer treatment, disease progression and recurrence. Eventually, the test might be able to pinpoint new mutations that occur over time and see whether a patient is becoming resistant to therapy, the company said in a statement.

Pathway could face an uphill battle as it brings its product to a rapidly growing market. The use of DNA blood tests for cancer screening will exceed $10 billion a year by the end of the decade, according to Cowen & Co. estimates cited by Reuters, signaling a lucrative opportunity for diagnostics makers.

But Pathway faces competition from other diagnostic outfits developing liquid biopsy cancer tests, including Guardant Health and Personal Genome Diagnostics. Roche ($RHHBY) and Illumina ($ILMN) also have similar tests in the works, turning up the heat on Pathway as it tries to distinguish itself from rivals in the field.

And the company hasn't shown how well its tests perform in humans, Reuters points out. Pathway kicked off two clinical trials involving patients but has not yet published results, Plante told the news outlet. Still, the company says the test is more than 99% accurate in finding mutations in blood samples with at least 9 copies of a tested mutation, Reuters reports, a potentially game-changing number in light of some stiff competition.

- read the statement
- here's the Reuters story