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    This week, the Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, sent a letter urging House Energy and Commerce and Senate Health, Education, Labor and Pensions leaders to enact diagnostics reform  provisions (The VALID Act) in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022.

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    • NEWS: AdvaMed leads stakeholder letter calling on Congressional leaders to pass the #VALIDAct. "[Current] regulatory uncertainty … jeopardizes investment in the next generation of diagnostics that will provide for improved patient outcomes.” Read more: https://t.co/1lA6CmhTAg

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    Labs that create and use their own tests are not required to register them, demonstrate to independent regulators that they’re reliable, or publicly report instances of patient harm resulting from …

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    • .@theranos founder Elizabeth Holmes may have been convicted of fraud, but the policy that let the company’s faulty blood test go to market still exists. Congress should pass the bipartisan #VALIDAct recently added to the #FDASLA and close that loophole. https://t.co/lrIPE6ki8j

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    This month we’ll be focusing on the VALID Act and its impact on laboratory developed tests. We sat down with CAP President Dr. Emily Volk to get some background on the legislation and what to expect m

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    • For our May Advocacy Recap CAPcast, we sat down with CAP President @EEVMD to discuss the #VALIDact and its impact on laboratory developed tests: https://t.co/2xQUgCc6Kc. https://t.co/0iNxOeNvei

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    For most of its existence, the now-defunct biotech startup Theranos operated in so-called “stealth mode” — disclosing little about the science behind its blood-testing device while boldly claiming that it could deliver faster, more convenient, and cheaper diagnostic tests to millions of people anxious to know if they had diabetes, cancer, cardiovascular disease, or scores of other conditions.

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    • “If @US_FDA had required #Theranos to submit its lab developed tests for premarket review, the agency might have been able to shield patients from harm,” says our @RichardsonLiz The #VALIDAct would strengthen oversight to protect Americans. https://t.co/BWW6rHVUoH

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    The agency cites concerns that some manufacturers’ claims about test performance “may not be supported with sound scientific evidence.”

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    • “[This warning] is a helpful first step, I think what’s needed is more comprehensive reform of F.D.A.’s oversight of these tests,” says our @RichardsonLiz. The #VALIDAct would help give @US_FDA the authority it needs to protect Americans. https://t.co/HRVMncr2qY

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    The Pew Charitable Trusts wrote to the U.S. House and Senate sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act on Aug. 23 recommending changes intended to ensure that patients are protected under the proposed regulatory framework for in vitro clinical tests.

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    • @RepLarryBucshon @US_FDA The #VALIDAct would strengthen oversight of diagnostic tests by giving FDA clear authority to set risk-based requirements for all tests, including the ones made and used in laboratories. Recommendations👇 https://t.co/hIP3zKGtfY

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    For most of its existence, the now-defunct biotech startup Theranos operated in so-called “stealth mode” — disclosing little about the science behind its blood-testing device while boldly claiming that it could deliver faster, more convenient, and cheaper diagnostic tests to millions of people anxious to know if they had diabetes, cancer, cardiovascular disease, or scores of other conditions.

    Tweet Tweets with this article
    • “If @US_FDA had required #Theranos to submit its lab developed tests for premarket review, the agency might have been able to shield patients from harm,” says our @RichardsonLiz. The #VALIDAct would strengthen oversight to protect Americans. https://t.co/1kFKbHfnHc

  • Mashup Score: 0

    For most of its existence, the now-defunct biotech startup Theranos operated in so-called “stealth mode” — disclosing little about the science behind its blood-testing device while boldly claiming that it could deliver faster, more convenient, and cheaper diagnostic tests to millions of people anxious to know if they had diabetes, cancer, cardiovascular disease, or scores of other conditions.

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    • The #Theranos case is just one example of how the lack of transparency and oversight in the diagnostic test industry is harmful to millions of people. If passed, the #VALIDAct could help protect vulnerable Americans, says our @RichardsonLiz https://t.co/mo3mIoEyR7