Epic Sciences said today it will partner with four Canadian breast cancer centers to carry out a clinical validation trial of the company’s blood test, designed to predict women who are at risk of late recurrence of metastatic breast cancer following treatment for the disease.
Pamela Goodwin, M.D., Director of Mount Sinai Hospital's Marvelle Koffler Breast Centre at Mount Sinai Hospital in Toronto. Joining Mount Sinai—part of Sinai Health System—are Princess Margaret Cancer Centre, Sunnybrook Odette Cancer Centre, and BC Cancer.
The four cancer centers plan to enroll approximately 1,000 patients over three years in the trial, designed to assess Epic Sciences’ “No Cell Left Behind” circulating tumor cell (CTC) detection and characterization platform.
The blood test is intended to allow counting of CTCs—as well as evaluate protein biomarker expression and subcellular localization as well, when used with the company’s 4 or 5-color immunofluorescence assays; gene amplifications, deletions or rearrangements by DNA fluorescence in situ hybridization (FISH); and genomic aberrations via mutation or copy number variation (CNV) analysis via next-generation sequencing (NGS).
Epic Sciences says its platform needs 7 minutes to acquire an entire image of 6 million stained cells on a 1×3 slide. That image, which consists of about 20GB of data, is transferred to the cloud, where algorithms run and find the rare events in about 2 minutes, according to the company.
“Millions of women, already treated for localized breast cancer, are in remission but are still at risk of a clinical recurrence of metastatic breast cancer,” said Dr. Goodwin, who is also a Professor of Medicine at the University of Toronto. “The potential for a blood test to help identify which patients need to be closely monitored and considered for earlier therapy is an unmet need facing breast cancer treatment management.”
In addition to Epic Sciences, which is donating its technology, the trial is being supported by Hold'em for Life Charity Challenge and the Breast Cancer Research Foundation.
Epic Sciences is partnering with 45 academic institutes and 65 biopharma companies, and is involved in more than 250 clinical studies focused on the dynamics of cancer growth, evolution, and heterogeneity.
Epic Sciences has developed and validated Oncotype DX AR-V7 Nucleus Detect, a clinical blood test intended to help guide clinicians on therapeutic decisions involving metastatic prostate cancer. Late last month, the company and partner Genomic Health announced that Medicare Administrative Contractor Palmetto GBA issued a positive final local coverage determination (LCD) for Oncotype DX AR-V7 Nucleus Detect. The final LCD recommends Medicare coverage effective December 10, 2018.