LDTs

FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

Industry Buzz

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [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...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane¬†bio and Elaine Naughton¬†bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

LEGISLATION

From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]

NEWS

Government Shutdown: The Impact on the Agencies that Regulate Labs

As we go to press, the longest U.S. government shutdown in history drags on with no end in sight. And while it may not affect your lab directly, the shutdown will have an indirect impact to the extent … [Read more...]

FDA

LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]

GUIDELINES

FDA Warns About Biotin Interference With Lab Tests

In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes … [Read more...]

LAB SAFETY

CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]


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