Chronix preclinical study boosts CLIA goal for cell-free DNA cancer test

California's Chronix Biomedical said its cell-free DNA blood test designed to detect residual tumor cells worked successfully in a study involving dogs with breast cancer. The trial builds on a pilot study released earlier this year that showed the test's viability in breast cancer patients following surgery.

The journal PLOS ONE published the company's animal study. It matters because it affirmed some commonalities in human and canine breast tumors, and the finding will help inform future research. But the data it produced will also help propel the company's test and lab toward its CLIA certification, which is expected by June 2014.

"This is disruptive technology. No one is doing it this way," CEO Howard Urnovitz told FierceDiagnostics. "We will replace risk and probability tests with real-time measurements of cancer."

For the study, Chronix worked with a team at the University Göttingen Institute of Veterinary Medicine in Göttingen, Germany, and studied five canine mammary carcinomas. All had chromosome instability similar to human breast cancer samples. Additionally, however, the test detected a recurrent deletion not typically found in human breast cancer.

Chronix believes its cell-free minimal residual disease DNA blood test will help move personalized medicine forward. It allows doctors to make specific treatment decisions based the specific genetic makeup of a patient's tumor and can also determine if tumor cells are still in the body after surgery. Urnovitz explained that Chronix's test goes beyond existing genetic tests that identify whether you have a certain cancer mutation (and point to whether you should take a specific drug to fight it) or predict the probability a person will get cancer.

"This technology is not whether you might get [cancer]. It is whether you have it or don't have it now," he said. "You now have a window into the human body that can tell you whether the tumor is still present or not. This has never been done."

Urnovitz said the company will work with public and private academic centers to teach them how to use its blood test to enhance cancer treatment. As well, Urnovitz said, negotiations are underway "with several pharmaceutical industry leaders" developing cancer drugs to promote Chronix's testing tech in the context of companion diagnostics work.

Founded in 1999, Chronix is based in San Jose, CA, but also maintains laboratories in Göttingen, Germany, and Brookings, SD. Chronix bills itself as the first company to use next-generation sequencing on cell-free DNA. It employs 13 people and has raised $27 million in equity financing to date.

- read the release

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