FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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LDTs: Top 10 New FDA Diagnostic Approvals of 2017
From – Laboratory Industry Report
The phrase “most exciting FDA laboratory developed test approvals of the year” is no longer an oxymoron. The agency remains glacial in tempo…
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FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From – Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
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Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From – Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
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FDA Watch: New Moves to Boost CLIA Transparency
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FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”
From – Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…
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FDA Watch: Two More Zika Tests Get Emergency Use Authorization
From – Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
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FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
From – Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
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FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster
From – Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…
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FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
From – Laboratory Industry Report
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by…
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