With Katherine Ellen Foley and Emily Martin.
On Tap Gottlieb, Giroir tussle after FDA cracks down on kratom. Clinical laboratories argue that FDA doesn’t have the authority to require premarket review of laboratory-developed tests.
It’s Tuesday, welcome back to Prescription Pulse. We’re still slack-jawed about these century-old lung samples being studied for 1918 flu virus mutations.
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Labs preparing for increase in POC, homest testing post-pandemic
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Labs preparing for increase in POC, home testing post-pandemic
Adam Bonislawski, 360Dx
Dan DeLong for KHN
A clinical lab technician at the UW Medicine Virology laboratory in Seattle processes patient samples for COVID-19 on March 11, 2020.
COVID-19 has driven an uptick in healthcare delivery approaches like telemedicine and point-of-care, home, and direct-to-consumer testing, a shift that some observers believe could continue to accelerate even after the pandemic is over.
It is a trend that has a potential downside for traditional labs as increased POC and DTC testing could cut into their business. It is also, though, a pattern that fits with the industry s move even pre-pandemic toward more patient-centered models of testing and sample collection and one that some in the business suggest could ultimately expand the overall demand for testing.
ASM joined partners in submitting the following request to Congress.
Dear Chairman Leahy, Vice Chairman Shelby, Chair Murray and Ranking Member Blunt
cc: Chair DeLauro, Ranking Member Granger and Ranking Member Cole:
We, the undersigned organizations, respectfully request that you provide $60 million for the Advanced Molecular Detection (AMD) program at the Centers for Disease Control and Prevention (CDC) in the Fiscal Year (FY) 2022 Labor, Health and Human Services, Education and Related Agencies bill. The AMD program uses next generation sequencing (NGS) to bring the concept of precision medicine to bear for “precision public health.”
AMD gives us new tools to detect disease faster, identify outbreaks sooner, and protect people from emerging and evolving disease threats. It informs vaccine development, helps identify and track antimicrobial resistance and foodborne illness, and informs the development of diagnostics for new, existing and emerging diseases. AMD has played a
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