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as a point-of-care tool for use by doctors, hospitals, and clinical labs.
This is a challenging objective, because makers of such diagnostic devices need to prove to regulators and health care payers that the data they generate can make a difference in the choice of treatments or their outcomes. To do this, companies must usually conduct clinical trials. The lack of funds to carry out studies was a big factor in the decision by another company developing a circulating tumor cell diagnostic system, Waltham, MA-based On-Q-ity, to cease operations in April. Janssen Diagnostics (formerly named Veridex) has been collaborating with researchers at Massachusetts General Hospital on the CTC-iChip, an antibody-independent device to capture circulating tumor cells. The Janssen unit has not announced a timeline for its commercial development.
As for ApoCell, its new NCI grant will help pay for clinical studies. The company has a head start from the clinical trials it has already supported with the ApoStream technology for clients or research collaborators, Davis says. ApoCell will most likely put non-small cell lung cancer first on its list as a focus of studies to prove the clinical utility of the device, he says. The company has been working with researchers at the University of Texas M.D. Anderson Cancer Center to detect the mutations found in tumor biopsy samples from patients with non-small cell lung cancer, and compare them with mutations found in the circulating tumor cells of the same individuals. The research focused on various mutations of a cell surface protein called EGFR, or epidermal growth factor receptor, which is the target of a group of cancer drugs such as erlotinib (Tarceva).
Through studies like these, researchers can explore some interesting questions that could help physicians to better understand the development of an individual’s disease over time, and possibly to direct the choice of drug treatments.
If the mutations found on the primary tumor are the same as those found on the circulating tumor cells, then a mere blood sample could be yield a diagnosis just as effectively as a tissue biopsy under some circumstances. It could suggest, for example, that the primary tumor would be vulnerable to a drug that blocks EGFR.
On the other hand, if the mutations on the primary tumor are different from those found on the circulating tumor cells, the circulating cells could provide a guide to the next course of treatment that will be needed. The circulating tumor cells may have evolved to resist the initial drugs given to control the primary tumor. But they may bear new mutations that would make them vulnerable to another drug, if one already exists to target those mutations.
The circulating tumor cells may also help researchers discover previously unknown cancer mutations that could be exploited as new targets for novel drugs.