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Regulations Threaten Precision Medicine Innovations Against Cancer

(p. A15) The federal government is threatening to limit treatment options for doctors fighting cancer.

. . .

At issue is whether reimbursements will be available to most physicians, hospitals and patients for a diagnostic technology known as next-generation sequencing. A cornerstone of the emerging field of precision medicine, NGS tests analyze molecular changes that occur in cancerous tumors and show up in biopsies.

. . .

Under the proposed policy, only one of hundreds of laboratories that currently offer NGS testing would meet all the new reimbursement requirements. The policy would in effect force clinicians and institutions to send all NGS testing to a single vendor, Foundation Medicine .

This is unfair to cancer patients. The proposal would result in a monopoly, allowing price manipulations, decreasing quality, and potentially contributing to market failure. It would turn the entire genomic-testing industry upside-down. The FDA is already unable to keep up with advances in precision medicine. Restricting access to cutting-edge molecular testing would stifle growth in precision medicine at approved testing sites nationwide. The limits could prevent desperately needed innovation, setting back progress in genomic testing and oncology by at least a decade.

For the full commentary, see:

Olivier Elemento. ''A New Regulatory Threat to Cancer Patients; Washington may impose needless limits on genetic testing." The Wall Street Journal (Mon., Feb. 26, 2018): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Feb. 25, 2018.)

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