PRESS RELEASE

06.24.2016

Epic Sciences introduces sensitive HRD liquid biopsy test for PARP inhibitor clinical trials.

Analysis of CTCs identifies HRD positive cells through single cell imaging techniques.

Epic Sciences unveiled a liquid biopsy test that more sensitively detects cancers susceptible to PARP inhibitors by targeting homologous recombination deficiency (HRD) in individual circulating tumor cells (CTCs). The new test has already been incorporated into numerous clinical studies of HRD-targeted therapeutics in multiple cancer types.

Over 230 clinical trials are investigating novel therapies targeting DNA damage response pathways, including PARP, ATM, ATR, DNA-PK and WEE-1. Drugs targeting these pathways may be effective for a broad spectrum of cancers. However, detecting patients with HRD-positive metastatic disease has proven difficult due to tumor heterogeneity, the invasive nature of tissue biopsies in late stage patients, and the expense and delays involved with genomic testing that often impairs patient enrollment.

“Remarkably, utilizing this non-invasive blood test, we found that 30% of a cohort of 196 advanced prostate cancer patients harbored CTCs with the HRD biomarker. That is double the incidence as described through traditional genomic approaches,” explained Ryan Dittamore, vice president of translational research and clinical affairs at Epic Sciences.

Potential for faster screening without genomic sequencing.

Epic Sciences and Memorial Sloan Kettering Cancer Center presented data at the annual ASCO meeting earlier this month that suggests that Epic Sciences’ new test can detect a tumor cell’s HRD status based solely on analysis of protein expression and cellular morphology, independent of genomic sequencing. An imaging-based screening test would significantly reduce costs and identify patients within one week of a blood draw. In contrast, next-generation sequencing tests often require up to five weeks — a delay likely to interfere with treatment decisions.

The study analyzed an initial cohort of 597 CTCs by both imaging and single cell sequencing to detect genomic scarring characteristic of HRD. Striking differences in cell size, morphology, and texture differences were observed between CTCs with germline BRCA alterations and CTCs without HRD alterations. The HRD imaging algorithm was validated on 6,973 CTCs from 196 patient blood samples received prior to a therapeutic intervention. Patients who were found to have HRD-positive CTCs had worse outcomes on standard of care therapies.

“We are in a great position to identify patients who are likely to respond to PARP inhibitors who would normally have poor outcomes on standard of care therapies, all through a non-invasive blood test that can be performed in the time frame required to make therapeutic decisions,” said Murali Prahalad, Ph.D., CEO of Epic Sciences.

The Epic Sciences HRD liquid biopsy test is being offered as part of its expanded menu of Biopharma Solutions.

“Interest in adopting our test from biopharmaceutical companies and academic investigators focused on novel HRD-targeted therapies has exceeded our expectations, principally driven by technical and operational difficulties utilizing current tissue sequencing technologies,” said Dittamore.

For more information about the Epic HRD Test please visit our Biopharma Solutions.

About Epic Sciences

At Epic Sciences, we develop clinically proven predictive tests to detect and monitor cancer at the individual cell level. With a proprietary rare-cell detection engine, we provide insights to clinical, biotech, pharmaceutical and academic teams on how cancer emerges, mutates and remits so they can make pivotal decisions at every point in patient treatment with greater certainty. Recognizing the unique nature of each person’s cancer, we offer truly personalized diagnostic tests, while being non-invasive for the patient.

We have developed the first clinically proven predictive test for metastatic castration-resistant prostrate cancer (mCRPC), the Epic AR-V7 test. Using the same rare-cell detection platform and Epic’s biobank of over 30,000 blood samples, each profiled with predictive biomarkers, we partner with leading pharmaceutical and biotechnology companies, major cancer centers, the National Cancer Institute (NCI), and the National Institutes of Health (NIH) to pursue additional predictive tests for breast, ovarian, colon and other cancers and diseases. Our mission is to revolutionize cancer care and therapies to make them as precise, safe and life-sustaining as humanly possible.

For more information, visit epicsciences.com.

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Epic Sciences Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com,+1.858.344.8091