Companies like Quest, LabCorp and others have been in the forefront of pandemic response by creating innovative new laboratory diagnostic tests (LDTs) for detecting the SARS-CoV-2 virus. The FDA has … [Read more...]
FDA Watch
Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs
September 9, 2020
The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. … [Read more...]
LDTs
FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
August 4, 2020
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
January 30, 2020
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
January 30, 2020
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
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
April 15, 2019
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
January 28, 2019
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
January 23, 2019
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
January 3, 2018
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...]
