EMERGING TESTS

Nonculture Molecular Tests Speed Diagnosis of Bloodstream Infections

The T2Bacteria Panel (T2Biosystems; Lexington, Mass.) can rapidly and accurately diagnoses bloodstream infections (BSIs) caused by five common bacteria, according to a study published May 14 in the … [Read more...]

FDA

FDA Watch: Agency Issues New Guidance on Biotin Interference Testing

On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]

INDUSTRY BUZZ

FDA Watch: First Zika Assay Gets Green Light for Marketing

Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]

FDA

New FDA Guidance Tells IVD Makers How to Test for Biotin Interference

On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Approves New STD Screening Assay Applications

The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, … [Read more...]

NEWS

FDA Watch: Agency Okays Marketing of Zika Test for First Time

Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]

FDA

Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay

As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval. So, when the product undergoes significant changes, it often triggers … [Read more...]

INDUSTRY BUZZ

FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity

After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for … [Read more...]

NEWS

FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]

TOP OF THE NEWS

New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics

Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health … [Read more...]


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