Hologic to launch 2nd coronavirus test amid broader sales slide

The molecular diagnostics business posted its best growth rate in eight years, but the breast health and surgical segments slowed as a result of postponed elective surgeries.

By Susan Kelly • April 30, 2020

AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices

The trade group wants indefinite exemptions for imaging components and devices used in ventilators, among other items. It also floated a compromise: re-imposing them one year after the pandemic passes.

By Nick Paul Taylor • April 30, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

GE reducing healthcare headcount in $700M cost-cutting drive

The cuts come as the conglomerate seeks to adapt its business to volatility and pressures created by the global coronavirus pandemic.

By Nick Paul Taylor • April 29, 2020

LabCorp pulls 2020 guidance as testing demand plunges due to COVID-19

CEO Adam Schechter told investors that increasing capacity for coronavirus antibody and molecular tests will likely offset some of the volume shortfall, but that small slice of its business isn't enough to "make up for the difference."  

By Greg Slabodkin • April 29, 2020

Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. But whether it can truly help people is not entirely clear.

By Ben Fidler • April 28, 2020

LabCorp, Quest expand COVID-19 antibody testing nationwide

Amid the moves by the giant commercial labs, a White House plan released Monday says the administration is still exploring how to improve the reliability of these products.

By Greg Slabodkin • April 28, 2020

FDA encourages remote review of digital pathology slides amid COVID-19

The agency's latest effort to support greater access to medical devices during the pandemic follows a move by CMS that opened the door for pathologists to work away from the lab.

By Susan Kelly • April 27, 2020

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

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