San Diego’s Epic Sciences said today it has signed an agreement with LabCorp (NYSE: LH) to help speed up European clinical trials that are using Epic’s technology to identify tumor cells in the blood.
LabCorp, the Burlington, NC, company officially known as Laboratory Corporation of America, operates one of the world’s largest networks of medical laboratories for testing clinical samples. Under their agreement, LabCorp’s central lab in Belgium will pre-process blood samples from clinical trials throughout Europe and send prepared slides to Epic’s certified lab in La Jolla.
Epic, founded in 2008 with technology developed in the lab of Peter Kuhn, a cell biologist at The Scripps Research Institute in San Diego, describes its test as a “blood fluid biopsy” to detect and analyze circulating tumor cells in blood samples.
According to Epic Sciences, a benign solid tissue tumor appears to begin shedding tumor cells into the blood stream at the first signs of malignancy. The tumor cells circulate through the system (many are destroyed) and eventually stick to the inside wall of a distant blood vessel, where they can form secondary tumors through a process known as metastasis. Conventional cancer diagnostics cannot detect these rare tumor cells—a blood sample with 30 million cells on a prepared slide typically has only about five of these circulating tumor cells.
Epic uses fluorescent antibodies that bind to cytokeratins, a key protein in circulating tumor cells that can be used to identify different types of carcinomas. Epic says preparation of the slides is crucial, and one reason why the deal with LabCorp is important. The company uses a digital microscope and an image-processing algorithm to scan each slide for clumps of aberrant fluorescence. The process requires high-performance computing to help analyze and manage the data, and high-definition imaging to help cellular pathologists identify and analyze fluorescing clumps of the rare tumor cells.
Murali Prahalad, who was hired as Epic’s CEO in August, says the company’s technology can be used as a “companion diagnostic” to categorize patients for particular cancer drugs, based on the type of circulating tumors cells in their system. Once treatment begins, the technology also can be used to monitor how well a particular regimen is working.
“We are receiving clinical trial samples from around the world, and returning results in 72 hours,” Prahalad says.
The company eventually plans to seek regulatory approval for its diagnostic technology in the United States and European Union, Prahalad says. “The work before us now is really focused on automating the technology and taking our system through the regulatory process,” he told me by phone yesterday.
Establishing partnerships with big pharmaceutical companies is central to the company’s strategy. “At the beginning of 2013, we had six pharmaceutical partners,” Prahalad said. “We ended the year with 14,” and many more additional deals are in the works. All of them are paying partnerships, Prahalad says.
Epic has not had to raise additional venture capital funding since late 2012, when the company raised $13 million in a Series B funding round that included Domain Associates, Roche Venture Fund, and Pfizer Venture Investments. Since then, the company has grown from 25 to 40 employees.
So far, Epic has completed eight oncology clinical studies, and is involved in another 27 clinical trials around the world .
In a separate statement today, Epic Sciences says it plans to present six abstracts about its technology platform at the American Society of Clinical Oncology Genitourinary conference, which begins later this week in San Francisco. Epic says the studies were done in collaboration with its academic and pharmaceutical partners, including Memorial Sloan-Kettering Cancer Center in New York, Institute of Cancer Research in London, Weill Cornell Medical College in New York, the University of Michigan, and Tarrytown, NY-based Progenics Pharmaceuticals (NASDAQ: PGNX).
“The questions addressed in these studies with our collaborators represent critical technical and clinical questions associated with the robustness of future oncology diagnostic solutions utilizing real-time liquid biopsies,” Prahalad says in the statement. “Epic’s technology has an industry-leading level of sensitivity in detecting circulating tumor cells and the added benefit of enhanced molecular characterization of CTCs to develop crucial tools for better cancer management.”