The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]
Coronavirus
FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
March 19, 2020
Coronavirus
Two commercial labs testing now for COVID-19
March 8, 2020
Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
March 2, 2020
Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its … [Read more...]
Coronavirus
Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests
February 25, 2020
The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a … [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...]
CLIA
After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
February 22, 2019
When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per … [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...]
CONSUMER FRAUD
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
October 19, 2018
Aetna Settles with States of Victims of HIV Meds Envelope Privacy Snafu Case: Aetna is still paying for a disastrous miscalculation that may have revealed the HIV status of 12,000 beneficiaries … [Read more...]
PATIENT SAFETY
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
September 27, 2018
Free Testing Supplies to Physicians Costs Massachusetts Lab $1.374 Million Case: A federal court ordered Calloway Laboratories, Inc. to pay $1,374,058 to settle claims of falsely billing … [Read more...]
ANTI-KICKBACK
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
September 5, 2018
Kickback Settlement Costs Pennsylvania Hospital $13.1 Million Case: The most expensive kickback settlement of 2018 to date features Post Acute Medical, LLC (PAM) in the starring role. The case … [Read more...]
