Epic Sciences has received its Clinical Laboratory Improvement Amendments (CLIA) license from the Centers for Medicare and Medicaid Services and the State of California for its circulating tumor cell lab in San Diego to advance new cancer diagnostics.
The company can now accept clinical samples from 46 U.S. states, in addition to accepting clinical samples in Europe and Asia through their Labcorp collaboration.
With CLIA certification of the lab and 510(k) clearance of the platform, Epic can develop its own laboratory developed tests (LDTs) and has recently published research on assays for prostate cancer and lung cancer, including one that can detect PD-L1/PD-1, an important target of some of the most exciting immunotherapies for cancer (such as Keytruda from Merck and Opdivo from Bristol-Myers Squibb – see Forbes article: The Most Important New Drug of 2014).
What Epic sees in a tube of blood
Epic has shown that our no cell left behind technology captures a wide variety of circulating tumor cells that are missed with other technologies, including CellSearch (see data here). This allows us to see cancer heterogeneity, which is associated with chemotherapy resistance. Also because we capture the whole cell instead of circulating fragments, Epic can see real-time protein dynamics such as the movement of androgen receptor from the nucleus to the receptor to help inform whether an AR prostate cancer treatment is working or not.
An Epic Companion
Epic also aims to use its technology to develop companion diagnostics, which identify patients who should receive a specific drug. The company has more than 17 pharmaceutical partners, including Genentech and Pfizer.
"With the recent move to our expanded facility in San Diego and this initial CLIA certification, we have executed on our next growth phase and continued our commitment to quality laboratory testing to provide accurate, reliable and timely test results. Furthermore, Epic can now participate in a greater variety of therapeutic clinical trials as a companion diagnostic partner," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences.
Read the press release here.