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Congress is currently working on legislation to fund the federal government for the next year through a package that will likely include the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022. This piece of legislation would make much needed improvements to the way diagnostic tests are regulated in the United States, to safeguard patients and ensure they receive accurate, reliable test results critical to their care.
Lung cancer is at the forefront of personalized medicine, with a growing number of targeted therapies providing more effective treatment options for patients with specific types of lung cancer. These therapies depend upon accurate results from diagnostic tests to match patients with the right treatments.
Currently, not all diagnostic tests are regulated equally. Some tests, known as laboratory-developed tests, or LDTs, are not overseen by the U.S. Food and Drug Administration (FDA). As a result, some low quality LDTs with variable performance, which may provide inaccurate test results, have gone unchecked. Inaccurate test results can lead to patients not receiving the best treatment options for their specific type of lung cancer and instead being inappropriately prescribed ineffective treatments with potentially harmful complications. The VALID Act of 2022 would give FDA the authority it needs to oversee these tests and ensure they meet the appropriate thresholds for accuracy.
All diagnostic tests must be subject to stringent regulation to ensure their accuracy to ultimately safeguard patients. At the same time, test developers must maintain the ability to innovate and keep pace with the ever-evolving field of personalized medicine. The bill also includes flexibilities critical to ensure developers and labs are able to rapidly adapt and modify tests to meet the needs of patients.
The VALID Act of 2022 establishes a new, more balanced regulatory framework for diagnostic tests, providing flexibilities for labs and developers to innovate while bringing all diagnostic tests up to more equal performance standards. This legislation represents an important step forward in ensuring patients receive accurate, reliable test results on which their optimal care depends, while continuing to benefit from new developments in personalized medicine for lung cancer.
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