Diagnostics: Page 47
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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 -
Courtesy of Centers for Disease Control and Prevention
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 -
"Florida National Guard" by The National Guard is licensed under CC BY 2.0
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 -
Courtesy of Abbott, PRNewswire
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 -
Retrieved from Abbott, PRNewswire on March 19, 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 -
Courtesy of Abbott, PRNewswire
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 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on white". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
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 -
"20-0081-031 (200318-N-BT681-1010)". Retrieved from Navy Medicine.
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 -
"White House Press Briefing". Retrieved from The White House.
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 -
CDC/Hannah A Bullock; Azaibi Tamin. (2019). "covid-19 coronavirus microscopic image with blue colored viral particles". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
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 -
Retrieved from Flickr.
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 -
Alex Wong via Getty Images
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 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
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 -
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 1, 2020 -
Courtesy of Abbott
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 -
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 -
Photo illustration by Brian Tucker/MedTech Dive; photograph by dusanpetkovic via Getty Images
Tracking the impact of coronavirus on the medtech industry
Among the latest: As COVID-19 test sales boom, Hologic thinks its revenues this quarter may be 60% higher than last year's.
By Nami Sumida • Updated Sept. 11, 2020 -
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 -
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
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