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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FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry
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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From – Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
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FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
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FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From – Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
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FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From – Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
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FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From – Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
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FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
From – Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
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FDA Watch: Personalized Medicine Approvals Continue to Flow
From – Laboratory Industry Report
After a slow start to the year, new product business picked up significantly in the past four weeks. Here’s a rundown…
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FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals
From – Laboratory Industry Report
For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing…
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FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From – Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
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