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The organizations requested a list of the names and contact information for individuals in each state overseeing the supply chain for testing supplies and PPE.

More than 70 percent of labs surveyed experienced supply chain interruptions, forcing them to validate three or more diagnostic testing methods.

The group said the recommendations aim to standardize and improve warfarin response genotyping assays.

The PCR tests are being requested more often during the SARS-CoV-2 pandemic to rule out patients with other viral respiratory conditions.

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.

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