Though Most Liquid Biopsy Tests are LDTs, Stakeholders Continue to Weigh Regulatory Considerations

NEW YORK (GenomeWeb) – Building on a joint US Food and Drug Administration and American Association for Cancer Research workshop that took place last year, a group of drugmakers, test developers, and academics gathered at the American Association for Cancer Research annual meeting earlier this month to discuss concerns and challenges in establishing analytical and clinical validity for liquid biopsy tests.

Although most liquid biopsy tests are currently offered as LDTs, and as such need not be approved or cleared by the FDA, the diagnostics field is still paying close attention to the agency’s expectations and potential future regulation. In addition, it is facing concerns from clinicians regarding the analytical and clinical validity of the tests.

“The number of symposia and presentations at this meeting speaks to the variety of technologies being applied and the number of sponsors looking to grow into this field,” said Memorial Sloan Kettering Cancer Center’s Howard Scher, who leads an academic team working with Epic Sciences, and now Genomic Health, to advance a CTC-based test in prostate cancer.

“Unfortunately, there is a certain degree of performance that should be mandatory and what we are seeing now is that very few of these assays have really

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