Cepheid wins 1st FDA nod for point-of-care coronavirus test

The Sunnyvale, California-based molecular diagnostics company said there are currently close to 5,000 of its systems in the U.S. that can run its 45-minute test in hospitals.

By Greg Slabodkin • March 23, 2020

Lab industry 'alarmed,' says Senate stimulus bill fails to back testing ramp-up

Without $5 billion in assistance, the American Clinical Laboratory Association contends commercial labs are "being set up to perform COVID-19 testing at a loss." A Senate vote could come Monday.

By Greg Slabodkin • Updated March 23, 2020

Direct-to-consumer companies wade into coronavirus testing to fill gap

Everlywell said Monday it planned to donate its store of COVID-19 tests to hospitals, following guidance from FDA warning consumers of fraudulent at-home tests.

By Rebecca Pifer • Updated March 23, 2020

Diagnostic, device makers scrambling as COVID-19 sweeps US

What began as a potential Q1 headwind for medtechs manufacturing in China has quickly turned into a global crisis with unprecedented challenges and opportunities as the sector grapples with the pandemic.

March 20, 2020

Exact Sciences pulls 2020 sales guidance amid coronavirus uncertainty

Shares in the molecular diagnostics company rose 32% Thursday, suggesting investors are betting use of the firm's flagship colorectal cancer screening test will be relatively immune from the pandemic.

By Nick Paul Taylor • March 20, 2020

CMS urges hospitals to put off elective procedures

The guidelines suggest three tiers, with procedures like hip and knee replacements falling into the "consider postponing" category.

By Shannon Muchmore • March 19, 2020

Abbott latest to get FDA emergency use nod for coronavirus test

It's the seventh medtech to win the agency's emergency use authorization within the last week as the Trump administration attempts to leverage the private sector, including commercial labs, to boost the nation's testing capacity.

By Greg Slabodkin • March 19, 2020

New notified bodies trickle in ahead of looming MDR start date

The 12th notified body authorized for MDR work, and the first from Hungary, was listed in the NANDO database Friday: CE Certiso.

By Nick Paul Taylor • Updated March 20, 2020

FDA pulls plug on routine US inspections

The move to protect staff and acknowledge industry worries about outside visitors amid coronavirus comes a week after the agency said it would postpone nearly all overseas inspections through April.

By Nick Paul Taylor • March 19, 2020

How an 'overwhelmed' Buffalo lab facing coronavirus supply shortage signals nationwide struggles

The Western New York regional public health lab is a microcosm of the insufficient swab and reagent stocks labs face as they attempt to confirm COVID-19 cases and gauge the scope of their region's outbreak.

By Greg Slabodkin • March 18, 2020

MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates

A lack of harmonized standards worries the trade association. Meanwhile, the Medical Device Coordination Group issued new documents on software requirements, implant cards and unique device identifiers.

By Nick Paul Taylor • March 18, 2020

Hologic, LabCorp win emergency use nods as FDA eases rules to boost US coronavirus test volume

In some cases, manufacturers can distribute, and labs can use, new commercially developed tests prior to an emergency use authorization.​ FDA's updated policy also boosts states' authority to greenlight tests.

By Greg Slabodkin • March 17, 2020

To fight coronavirus spread, high-throughput tests bring potential benefits, challenges

Deborah Birx, White House coronavirus response coordinator, said labs will just as importantly need supplies to ramp up testing. The American Clinical Laboratory Association is concerned about potential supply shortages.​    

By Greg Slabodkin • March 15, 2020

Thermo Fisher coronavirus test gets FDA nod

Trump administration officials promised on Sunday that 2,000 labs would be running 1.9 million tests this week. Separately, the American Clinical Laboratory Association expects daily testing capacity to exceed 20,000 next week, with the potential to grow to 280,000 by April 1.  

By Maria Rachal • March 15, 2020

Trump declares national emergency, opening up billions for coronavirus

The president also teased an imminent FDA emergency use authorization for a test from Thermo Fisher, with LabCorp and Quest saying they're collaborating with Roche.

By Samantha Liss • Updated March 13, 2020

Roche is 1st commercial coronavirus test maker to win FDA emergency use authorization

After FDA allowed the company to pre-position its test in the U.S., Roche said it's committed to "going to the limits" of its production capacity to churn out millions of tests per month.

By Maria Rachal • March 13, 2020

Natera breaks ties with Qiagen on NGS testing, citing Illumina deal

The companies teamed up two years ago to develop cell-free DNA assays for a Qiagen reader system, but Thermo Fisher-bound Qiagen later shifted course, which Natera said was a "material breach of the agreement."

By Nick Paul Taylor • March 13, 2020

CDC chief: Reagents critical to coronavirus tests​ 'now are in short supply'

Separately, the government Friday announced funding for development of COVID-19 diagnostic tests from DiaSorin Molecular and Qiagen meant to detect the pathogen in about an hour. 

By Greg Slabodkin • March 13, 2020

FDA chief warns of supply 'pressure' on reagents for coronavirus tests

Qiagen, a major supplier of RNA extraction kits, confirmed to MedTech Dive Thursday that "extraordinary demand for coronavirus testing workflows" is challenging the company's capacity.

By Greg Slabodkin • March 12, 2020

White House, CDC under fire for availability of coronavirus tests

The Trump administration is facing criticism that federal agencies did not engage the big private labs early enough in the public health emergency.

By Greg Slabodkin • March 11, 2020

ECRI: Poor sterilization, failure to learn from device problems threaten patient safety

The 2020 list put together by the nonprofit ECRI Institute also highlights diagnostic errors as a top patient safety concern for a third consecutive year.

By Maria Rachal • March 10, 2020

Labs step up capacity to meet demand for nationwide coronavirus testing

The Trump administration is relying on the "enormous capacity" of commercial labs to enable wide availability of COVID-19 diagnostic testing to the American public through physicians offices and pharmacies. 

By Greg Slabodkin • March 10, 2020

ACC 2020 meeting canceled as coronavirus spreads in US

Abbott, Edwards and Medtronic were among the medtechs slated to present data at the American College of Cardiology's annual event. "This is a unique time for us all," the organization wrote in a statement Monday.

By Maria Rachal • March 9, 2020

$8.3B in coronavirus funding set in motion as federal agencies ramp up response

The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.

By Shannon Muchmore • Updated March 5, 2020

LabCorp launches coronavirus test, Quest in the wings

The updates from the major U.S. clinical labs come days after FDA OK'ed the use of lab developed tests that have not yet received emergency use authorization.

By Maria Rachal • March 5, 2020