ApoCell Entering the Commercial Ring In Rare Tumor Cell Diagnostics

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diseased cells are escaping from the original tumor, and may give rise to new tumors at different sites in the body—the process of metastasis. Doctors may decide to start the patient on a new course of treatment, based on the circulating tumor cell count and other monitoring tests.

But ApoCell’s clients wanted to capture circulating tumor cells from a wider range of cancers. The CellSearch system uses an antibody that sticks to tumor cells, to selectively “fish” them out from the large population of blood cells. However, the antibody doesn’t bind to every type of tumor cell. To extend that reach, the ApoCell device separates out tumor cells using charged electrodes. The tumor cells are pulled toward the electrodes, while blood cells are repelled from them, because of factors that differentiate tumor cells from blood cells. These include cell density and electrical conductivity.

“We’re isolating these cells based on biophysical properties,” Davis says. ApoCell has an exclusive license to the method, a microfluidic antibody-independent dielectrophoresis process developed at the University of Texas MD Anderson Cancer Center’s Laboratory of Diagnostic Microsystems.

The ApoStream device captures tumor cells without regard to their antibody affinities, and also preserves them as intact living cells that can be subjected to an array of different tests. The company began providing its own circulating tumor cell isolation service as an in-house offering to clients in 2010, and ApoStream has been used in a number of clinical trials. For example, San Francisco-based Nektar Therapeutics (NASDAQ: NKTR) has been using the service to obtain circulating tumor cells at intervals from participants in a late-stage trial of its experimental breast cancer drug etirinotecan pegol. The captured tumor cells are being tested for biomarkers that might help identify patients who would respond best to treatment with the Nektar drug.

With fine-tuning of the ApoStream settings, the device can isolate circulating tumor cells from other cancer types, including sarcoma and pancreatic cancer, Davis says.

In 2011, ApoCell received its first commercial order for ApoStream devices—a $2.9 million contract from SAIC-Frederick that funded  the company to develop a prototype for use by outside researchers contributing to the National Cancer Institute’s Pharmacodynamics Program. In June, ApoCell began delivering the first of 12 ApoStream instruments to investigator sites including Leidos Biomedical Research, formerly SAIC-Frederick, which operates the federally funded Frederick National Laboratory for Cancer Research.

ApoCell now has 45 employees, and reaped revenues of $8.9 million in 2012, according to Inc 5000’s 2013 report. The company plans to increase its commercial sales of ApoStream devices in 2014 to investigators who will use the device for research purposes only. No price has yet been set for the benchtop analyzer, which is about the size of a large microwave oven.

But ApoCell has recently announced much more ambitious plans. By 2016, ApoCell hopes to market the device as a clinical tool to guide doctors in their treatment decisions. For this goal, ApoCell got another boost from the National Cancer Institute in November—a $1 million Small Business Innovation Research (SBIR) grant to develop ApoStream … Next Page »

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