Epic Sciences Receives CE Mark for Liquid Biopsy Test Collection Kit. Enables Expanded Access to the Company’s Portfolio of Tests
San Diego – April 23, 2019 – Epic Sciences (“Epic”) announced today that it has received a CE mark for its Liquid Biopsy Test Collection Kit, allowing for sale and distribution of the company’s products within the European Economic Area (EEA). This kit is compatible with Epic’s rapidly expanding menu of diagnostic and clinical trial tests, including those for interventional use.
“Receiving CE mark for our Liquid Biopsy Collection Kit marks a significant milestone in our mission to enable global interventional clinical studies. Epic Sciences’ Functional Cell Profiling platform is unique in its ability to predict and monitor disease throughout the patient journey. Further enabling our global reach is a key strategic milestone toward offering all cancer patients the actionable information they need to drive therapeutic decisions,” said Pascal Bamford, Ph.D., chief scientific officer.
The CE mark approval indicates conformity with health, safety and environmental protection standards for products sold within the EEA. With the CE marking, Epic Sciences aims to advance strategic partnerships with clinical labs, pharmaceutical or biotechnology companies to broaden access to precision medicine.
The liquid biopsy collection kit is designed to stabilize and preserve blood samples for safe shipment to Epic Sciences processing sites around the world, ensuring reliable and accurate analysis. The kit offers clinical labs and pharmaceutical companies access to Epic Sciences’ expanding portfolio of proprietary diagnostic tests and solutions, including assays for immuno-oncology, prostate cancer and breast cancer.
About Epic Sciences
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic Sciences’ mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient’ s journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells. Epic Sciences No Cell Left Behind® technology helps match patients to therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Epic Sciences has partnered with Genomic Health to commercialize the Oncotype DX® AR-V7 Nucleus DetectTM test (AR-V7 Liquid Biopsy Test) in the US, which helps with therapeutic decisions between taxane chemotherapy or androgen-directed therapeutics in metastatic castrate-resistant prostate cancer. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic Sciences’ goal is to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real -time information to guide treatment choices. Epic Sciences is headquartered in San Diego.
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