Better outcomes through liquid biopsy

SAN DIEGO & REDWOOD CITY, Calif.—Genomic Health Inc. and Epic Sciences Inc. have joined forces to commercialize Epic Sciences’ AR-V7 liquid biopsy test in the United States through Genomic Health’s commercial channel. Genomic Health will have exclusive distribution rights to market and sell the Epic AR-V7 test through its commercial oncology and urology channels in the United States early next year.

 

Physicians will be able to order the test and view the results through the current physician portal. The test will be performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego. As part of the agreement, Genomic Health will make an equity investment in Epic Sciences.

 

The blood-based test detects the V7 variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTC) to help guide treatment selection in patients with metastatic castration-resistant prostate cancer (mCRPC). The liquid biopsy predicts therapy response to AR signaling inhibitors—Xtandi and Zytiga—in men with advanced prostate cancer.

 

Standard blood draws are sent to Epic Sciences' CLIA/CAP certified laboratory. Blood samples undergo a combination of brute-force imaging and single-cell analysis to analyze every nucleated cell to detect CTCs that harbor the AR-V7 biomarker.

 

“The test is a prognostic biomarker that determines who will and who will not respond to certain treatments,” explained Ryan Dittamore, vice president of translational medicine and clinical affairs at Epic Sciences. “Epic Sciences’ no cell left behind platform offers the highest clinical sensitivity and specificity for nuclear AR-V7 characterization. This enables a best-in-class test that provides clinically actionable information that can directly affect patient outcomes and health economics.”

 

He added, “Rather than looking at messenger RNA, the liquid biopsy detects the androgen-receptor splice variant, AR-V7, in the nucleus of circulating tumor cells. AR-V7 is a treatment-specific biomarker that predicts failure to AR signaling inhibitors. Detection of AR-V7 provides information that can help guide treatment selection and offer a better chance of survival for men with metastatic castrate-resistant prostate cancer. These patients and their physicians face a clinical decision point involving the use of Xtandi, Zytiga or taxane chemotherapy. Virtually all prostate cancer patients eventually progress to mCRPC.”

 

AR-V7 expression has been associated with resistance to androgen receptor signaling (ARS) inhibitors. Clinicians from Memorial Sloan Kettering Cancer Center recently published a study in JAMA Oncology demonstrating that mCRPC patients with AR-V7-positive CTCs had significantly better clinical outcomes when treated with taxane chemotherapy, suggesting that patients with detectable blood levels of AR-V7 should consider life-prolonging chemotherapy as an alternative to potentially less effective and more expensive hormonal treatment with ARS drugs. Based on these findings, an AR-V7 predictive test could enable advanced prostate cancer patients to avoid ineffective therapies and to receive chemotherapy at an earlier stage when it may be more beneficial.

 

“The validation study published in JAMA Oncology demonstrated that patients with AR-V7 positive CTCs have longer survival on taxane chemotherapy relative to those on AR signaling inhibitors,” said Dr. Howard Scher, study principal investigator and chief of genitourinary service at Memorial Sloan Kettering Cancer Center. “The growing body of evidence for the clinical utility of AR-V7 supports its use in clinical practice as a treatment-specific biomarker to guide treatment selection for patients with advanced prostate cancer.”

 

It is estimated that each year, about 50,000 mCRPC patients could benefit from knowing their AR-V7 status prior to selecting further treatment. With the use of this new test, the two companies estimate substantial healthcare savings per patient tested by tailoring treatment selection.

 

“This strategic collaboration allows us to leverage our successful commercial channel while continuing to generate growth across our business,” remarked Dr. Frederic Pla, chief business and product development officer at Genomic Health. “Epic Sciences’ CTC-based platform enables the delivery of clinically actionable information to prostate cancer patients at a critical treatment decision point. Offered as part of our Oncotype IQ Genomic Intelligence Platform that collectively assesses DNA, RNA and protein using either PCR, NGS or image-based analysis, Epic Sciences’ AR-V7 test will complement our expanding portfolio, which also includes Oncotype SEQ, our recently launched liquid biopsy mutation panel.”