Is There a Smart Path to Regulating Laboratory Developed Tests?
Xifin’s CEO sees a window of opportunity for lawmakers to modify the Final Rule on LDTs that will be a win-win for the industry and patients.
Xifin’s CEO sees a window of opportunity for lawmakers to modify the Final Rule on LDTs that will be a win-win for the industry and patients.
CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.
AMP is urging medical organizations to contact their elected officials to remove the VALID Act from a 2023 "omnibus" appropriations bill.
As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
Read MoreThe College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
Read MoreTo help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
Read MoreCertain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
Read MoreRoche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test is for use on the cobas Liat System. The false positive results may be related to two issues observed by Roche.
Read MoreThe i.C3 monitors the temperature inside a laboratory refrigerator or freezer and activates alarms if the temperature rises or falls outside of the acceptable range.
Read MoreCOLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.
Read MoreThe new guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutic products, address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes covid-19.
Read MoreLabComply manages laboratory safety, administrative and engineering controls, training, documentation, and reporting as part of MedTrainer’s all-in-one healthcare compliance solution.
Read MoreThe FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.
Read MoreThe webinar, sponsored by Technopath, will cover quality control regulations, setting the proper QC strategy/design, and troubleshooting SARs CoV-2 and other semi-qualitative tests in the laboratory.
Read MoreThe two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.
Read MoreI want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Read MoreThe changes make it easier to navigate to questions by topic.
Read MoreThe FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
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