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Blood Test Study Meets Goal, Validates Epic’s Prostate Cancer Target

Xconomy San Diego — 

Epic Sciences has developed a blood test that can predict how likely a patient with late-stage prostate cancer treated with hormones is likely to respond to an additional course of such therapy. Now, the San Diego-based company has additional data that it says supports use of its tests to determine when not to use hormone therapy.

In study results published Wednesday, the presence of the specific protein fragment that Epic (not to be confused with Verona, WI-based EHR software maker Epic Systems) tests for in circulating tumor cells predicted a shorter median length of survival for men whose disease has spread beyond the gland and isn’t responding to therapies that depress testosterone levels. According to the study, the median length of time patients who had this biomarker lived without their disease worsening was about three months compared to about six months in those who did not. More strikingly, the median length of their overall survival was about eight months, compared to more than two years for those who did not have the protein fragment.

Researchers said the results suggest that patients whose tests detect the biomarker should receive chemotherapy or join a clinical trial for an investigational therapy instead of receiving additional hormone therapy.

The Epic blood test, commercialized by Genomic Health (NASDAQ: GHDX), is part of a broader effort to develop new kinds of tests to detect and monitor cancer, as well as to avoid more invasive tissue biopsies. Myriad Genetics (NASDAQ: MYGN), in Salt Lake City, offers a blood test to inform treatment for last-stage breast cancer. Some companies are aiming to advance cancer diagnostics even further, with tests intended to detect the disease before any symptoms appear. For example, Grail, a spinoff of San Diego DNA sequencing giant Illumina (NASDAQ: ILMN) based in Menlo Park, CA, has raised millions to support its efforts to develop a “liquid biopsy” that can detect cancer in blood at the disease’s earliest stages.

The results from the latest study evaluating Epic’s blood tests were published in the Journal of Clinical Oncology. Blood samples from 118 patients were tested on both the Epic assay and a similar test developed by Johns Hopkins scientists that is currently used in research. Andrew Armstrong, associate director for clinical research in the Duke Cancer Institute’s Center for Prostate & Urologic Cancers, led the group.

“We have therapies to treat recurrent, metastatic prostate cancer, but they don’t work on everyone, and cross-resistance between newer hormonal therapies is a major emerging problem in our field,” said Armstrong, in a prepared statement. “It’s important to know which men are more likely to benefit from further hormonal therapies as well as to identify those men with little chance of benefiting in order to rapidly provide alternative, more effective therapies and or to develop new therapies for these men.”

Epic estimates 50,000 men in the U.S. have advanced prostate cancer. About half, Epic says, have Medicare coverage. Medicare covers the test, called Oncotype DX AR-V7 Nucleus Detect.

This latest study could support coverage of the test by insurance companies, as well as convince more physicians of its usefulness, said Ryan Dittamore (pictured), Epic’s chief of medical innovation and head of translational research partnerships, in an interview with Xconomy. Dittamore co-authored the study, which was backed by the Prostate Cancer Foundation, the Movember Foundation, and the Department of Defense’s Prostate Cancer Clinical Trials Consortium.

Epic, which tests blood samples at its San Diego lab, is working to develop more such tests, as well as studying cancers in conjunction with academic centers and working on drug development with biopharma companies, Dittamore said.

The company raised $52 million in September in a Series E round led by New York private equity firm Blue Ox Healthcare Partners to advance Epic’s development of blood tests for other cancers.

“There’s a lot of talk about being able to use blood tests to predict patient outcomes, and now we’ve done that in prostate cancer,” Dittamore said. “While, certainly, a lot of our colleagues are working on cancer drugs, the reality is that we need to know which drug to give which patient, and it’s not one-size-fits-all.”