Diagnostics

Commercial labs push for piece of $100B coronavirus relief

The trade group representing LabCorp and Quest wants HHS to allocate CARES Act money for expenses or lost revenue related to COVID-19. But there's strong competition from healthcare providers also hurting financially.

By Greg Slabodkin • April 06, 2020

FDA authorizes Cellex coronavirus antibodies test

It's the first test of its kind to obtain FDA emergency use authorization, although other companies are working to roll out serological tests for the virus.

By Maria Rachal • April 03, 2020

Medtechs navigate new normal as FDA shifts priorities to coronavirus

Companies are working to get diagnostics, respiratory devices and PPE to market amid rapidly evolving guidance from FDA. The agency's coronavirus-era operations may also impact work for device makers in other parts of the sector.

By Maria Rachal • April 03, 2020

FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up

The clearance will intensify competition in the space initially monopolized by Philips, with big medtechs like Roche aiming to enter. The ability to review images from anywhere may be critical amid the coronavirus pandemic.

By Nick Paul Taylor • April 02, 2020

BD rolls out test to detect coronavirus antibodies

Some experts point to serology tests, which may help identify people who have immunity, as a key tool in U.S. management of COVID-19 going forward. The BD test has already seen significant use in China.

By Susan Kelly • April 01, 2020

Abbott touts speed, scale of POC coronavirus test

The point-of-care diagnostic may detect the pathogen in as little as five minutes, processed on the same machines already in doctors' offices and clinics. Former FDA chief Scott Gottlieb called it a "game changer."

By Maria Rachal • March 30, 2020

Small PAMA victory in aid package, but labs remain in 'untenable situation'

Quest, LabCorp and others scaling up U.S. coronavirus testing will see a delay in Medicare payment reductions as part of the CARES Act signed into law Friday, but industry argues labs have been shortchanged on emergency funds.

By Maria Rachal • UPDATED: March 27, 2020 at 5:20 p.m.

UnitedHealth says self-swabbing study spurred FDA coronavirus policy change

The agency now allows onsite, self-collection of samples, after a nearly 500-patient study found self-administered tests about as accurate as those carried out by clinicians.

By Nick Paul Taylor • March 26, 2020

Tracking the impact of coronavirus on the medtech industry

Among the latest: Medtronic calls for an "unrestricted supply chain" for ventilators, warning against governments' potential "retaliatory actions" otherwise, and Thermo Fisher and Endologix withdraw 2020 financial estimates.

By Nami Sumida • UPDATED: April 6, 2020 at 11 a.m.

Clinical labs, White House tell different stories on testing backlog

The American Clinical Laboratory Association said without sufficient funds from the federal government, commercial labs might be forced to "retrench rather than keep building the capacity that is needed."

By Greg Slabodkin • March 24, 2020

CDRH pushes out response due date extensions, teleconference policy by at least a month

Less than two weeks after FDA wrote to industry extending deadlines for premarket application responses and warning of disruptions to in-person meetings, the agency lengthened those coronavirus-era changes.

By Maria Rachal • UPDATED: April 6, 2020 at 9:42 a.m.

MedTech Europe calls for delay of MDR until coronavirus crisis passes

The trade group argued industry is “working relentlessly” on getting devices to healthcare professionals fighting COVID-19, while simultaneously trying to maintain supply of other products, leaving little bandwidth to focus on new regs.

By Nick Paul Taylor • March 24, 2020

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 at 10:29 a.m.

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 at 10:42 a.m.

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.

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 at 5 p.m.

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