Resources for Food and Drug Administration (FDA)

Exact Sciences 'Surprised' By FDA Warning Letter

seekingalpha.com

The Food and Drug Administration’s [FDA] Office of In Vitro Diagnostic Device Evaluation and Safety issued a Warning Letter to cancer test developer Exact Sciences (EXAS) last Wednesday regarding regulatory matters related to its stool-based DNA test for colorectal cancer screening. According to the letter, the FDA believes that the commercial PreGen-Plus assay is a medical device requiring pre-market approval or clearance.

In a conference call with investors, Chief Financial Officer Charles R. Carelli Jr. said the company had been planning to apply for FDA approval, but was waiting for guidelines from the American Cancer Society as part of the process. He said the letter was a "surprise" in light of the numerous discussions the company previously had with the FDA over the device.

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