Gottlieb, Slavitt pitch $46.5B plan for COVID-19 contact tracing, isolation

Primary care doctors should be the main referral source for testing and contact tracing, according to a letter penned by a bipartisan group including former CMS head Andy Slavitt and former FDA Commissioner Scott Gottlieb.

By Shannon Muchmore • April 27, 2020

Abbott, DiaSorin coronavirus antibody tests get EUAs as lawmakers question others on market

As more diagnostics assessing possible immunity to the virus win FDA emergency use authorization, criticism is mounting over the accuracy of products the agency allowed on the market without the designation.

By Greg Slabodkin • April 27, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

FDA OKs updated instructions for Abbott POC coronavirus test amid accuracy concerns

The company's update comes as some providers raise red flags. The Cleveland Clinic compared five COVID-19 testing platforms and found Abbott's point-of-care test had a higher false negative rate than some counterparts. 

By Maria Rachal • April 23, 2020

MedTech Europe pushes for IVDR delay as MDR hold nears finish line

The trade group warned that "even before the COVID-19 pandemic, very little progress had been achieved" to get the In Vitro Diagnostic Regulation ready, which it said altogether warrants at least a 12-month delay.

By Nick Paul Taylor • April 23, 2020

Thermo Fisher and Roche enjoy COVID-19 diagnostic tailwinds, but warn of routine testing declines

Both companies disclosed big hits to business in China during first quarter earnings calls Wednesday, indicating negative impacts in the U.S. and Europe could be more apparent on second quarter balance sheets.

By Nick Paul Taylor • April 22, 2020

Quest Diagnostics testing volumes plunge due to coronavirus

"We're definitely living in extraordinary times," CEO Steve Rusckowski told investors Wednesday, reporting a decline by more than 40% during the last two weeks of March.

By Greg Slabodkin • April 22, 2020

COVID-19 bill with $25B for lab testing signed into law

The clinical lab lobby praised the legislation, which includes funds for serology and molecular testing.

By Shannon Muchmore • Updated April 24, 2020

As COVID-19 antibody tests proliferate, analysts see market worth billions for Abbott, Roche and others

Initial serology testing for U.S. healthcare workers alone could represent a $65 million opportunity, Cowen estimated in a report released Tuesday.

By Susan Kelly • April 21, 2020

LabCorp coronavirus test gets 1st FDA nod for at-home sample collection

The agency re-issued an emergency use authorization for the lab giant's molecular test to permit self-collection of nasal samples. It comes days after FDA voiced concerns about at-home diagnostics to test for the virus.

By Greg Slabodkin • April 21, 2020

Massive coronavirus testing ramp-up needed for US to reopen: report

A Harvard-led study contends 5 million daily tests are needed by early June to “deliver a safe social reopening,” which will have to quadruple by late July to fully remobilize the economy. It's a long stretch from current testing capabilities.

By Greg Slabodkin • April 20, 2020

Philips to invest $109M as COVID-19 drives connected care order growth

CEO Frans van Houten said sourcing component parts from affected suppliers has been a challenge amid increasing demand for ventilators, patient monitors and certain diagnostic devices.

By Nick Paul Taylor • April 20, 2020

Patchy IT infrastructure hobbling COVID-19 response, commercial labs and public health officials warn

Labs have to comply with a variety of state and federal reporting laws, all while fielding separate requests for data from state health information exchanges, governors, Medicaid plans, government contractors, and others.

By Rebecca Pifer • April 17, 2020

Abbott pulls 2020 guidance but expects coronavirus testing gains to show in Q2

"We haven't seen a quarter or any time quite like this before," new CEO Robert Ford told investors on an earnings call, during which he also addressed comments by some Trump administration officials on testing capacity.

By Greg Slabodkin • April 16, 2020

CMS doubles Medicare payment for coronavirus lab tests

The American Clinical Lab Association praised the move to increase reimbursement for high-throughput molecular diagnostics, an effort to speed and expand COVID-19 testing nationwide.

By Greg Slabodkin • April 15, 2020

Abbott enters coronavirus antibody testing fray

The company will begin shipping tests tomorrow and plans to request an emergency use authorization from FDA, a status two new serology tests achieved Tuesday.

By Maria Rachal • April 15, 2020

FDA authorizes 1st coronavirus test using at-home collection of saliva samples

The update to an EUA given last month for a test developed at Rutgers allows for at-home collection of specimens for the saliva-based test, although scope of the offering remains somewhat limited for now.

By Maria Rachal • Updated May 11, 2020

CMS issues guidance to free patients from copays for coronavirus tests

Clinical labs worry Congress hasn't provided funds for the “free testing." But recent legislation gives the labs rates negotiated before the pandemic; or if there wasn't one, allows them to negotiate on price.

By Nick Paul Taylor • April 13, 2020

Over 90% of 1M Abbott coronavirus tests sitting idle, White House official says

Deborah Birx, coronavirus response coordinator, said Abbott's testing kits were only able to run 88,000 tests in three weeks because labs don’t have the resources to operate the company's high throughput systems at full capacity.

By Greg Slabodkin • April 9, 2020

HHS, CVS, Walgreens get behind Abbott's coronavirus test

HHS has ordered 1,200 of Abbott's portable testing instruments and more than 30,000 of the point-of-care, quick-turnaround tests. The big retail pharmacy chains are also adopting the product as they expand drive-thru testing.

By Maria Rachal • April 8, 2020

OraSure wins BARDA contract for in-home coronavirus self-test

The test could become the first authorized by FDA for use at home to detect the virus, but its development won't likely be complete for at least another four to six months.

By Susan Kelly • April 8, 2020

White House official urges caution before assuming coronavirus antibody test accuracy

The FDA last month made it easier for companies to quickly develop serology tests. But the Trump administration’s coordinator for coronavirus diagnostic testing warned against overreliance on the tests before they are validated.

By Greg Slabodkin • April 7, 2020

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 6, 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 3, 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 3, 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 2, 2020