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Data amassed by analytics firm Diaceutics suggests fewer patients are coming into healthcare facilities and missing the chance for diagnosis, molecular testing, and treatment.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.
Diaceutics is projecting that FDA will soon approve more personalized drugs than all-comer drugs, but absent changes in diagnostics strategies many patients won't receive them.
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 survey results point to the need for greater education among patients so they can better advocate for themselves.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.