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The VITAL Act strikes a counterpoint to another bipartisan-backed bill, called VALID, that would give FDA oversight responsibilities over all clinical tests, including LDTs.
A pathologists' group has pointed out that the bill covers only EUA tests, and patients receiving tests with pending regulatory status may receive surprise bills.
The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.
The organization continues to support direct access genetic testing for healthcare decision making, while remaining neutral on recreational, novelty, lifestyle, and ancestry genetic testing.