Diagnostics: Page 43
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LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening
U.S. regulators simultaneously allowed the LabCorp test to be used in sample pooling, following the first such nod to a Quest Diagnostics test a week ago.
By Nick Paul Taylor • July 27, 2020 -
COVID-19 diagnostics emerging as prime investment target, SVB analysis shows
Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.
By Nick Paul Taylor • July 24, 2020 -
Explore the Trendlineâž”
Sara Silbiger via Getty Images
TrendlineTop 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 -
HHS renews COVID-19 public health emergency
The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.
By Shannon Muchmore • July 23, 2020 -
COVID-19 test demand backs 61% jump in Roche molecular diagnostic sales in 2020
"As far as the molecular diagnostics business is concerned, there is no doubt we will sell anything we can produce over the next half year,” Roche CEO Severin Schwan said on an earnings call with investors.
By Nick Paul Taylor • July 23, 2020 -
Courtesy of Quest Diagnostics
Quest says COVID-19 hotspot spikes starting to hit routine testing recovery
In addition to soaring demand for coronavirus testing, the lab giant's Q2 was helped by gradual improvement in base testing volumes. But recent outbreaks have sent numbers down again in July.
By Greg Slabodkin • July 23, 2020 -
Medical device deal values down 88% amid COVID-19 disruption: PwC
Going forward, M&A may rise in light of recent deferral of elective procedures, which analysts say “could create the need for significant consolidation as companies work to remain competitive.”
By Nick Paul Taylor • July 23, 2020 -
Thermo Fisher rakes in $1.3B in coronavirus-related Q2 revenue
The company expects momentum to continue in the third quarter after posting springtime results showing a more than 70% jump in its diagnostic and healthcare end market sales fueled by soaring demand for COVID-19 testing.
By Nick Paul Taylor • July 22, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
AdvaMed launches COVID-19 test registry to address shortages
Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.
By Nick Paul Taylor • July 22, 2020 -
4 healthcare sticking points as Congress weighs next coronavirus relief bill
Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.
By Rebecca Pifer , Samantha Liss • July 21, 2020 -
FDA eases rules on viral transport media to boost availability for COVID-19 testing
In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.
By Nick Paul Taylor • July 21, 2020 -
Courtesy of Centers for Disease Control and Prevention
Quidel says its COVID-19 antigen test is now on par with PCR accuracy
Results suggest the product is more sensitive than a rival test sold by BD. Some analysts say that could help shore up concerns about the faster, point-of-care tests' accuracy.
By Greg Slabodkin • July 20, 2020 -
Courtesy of Quest Diagnostics
Quest coronavirus test becomes 1st with FDA OK for sample pooling
The technique is "not a magic bullet," Quest's chief medical officer said, with demand for its COVID-19 services still overwhelming capacity. However, rival LabCorp said it has reduced its average turnaround time for results.
By Maria Rachal • July 20, 2020 -
Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip
Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.
By Nick Paul Taylor • July 20, 2020 -
Courtesy of Quest Diagnostics
3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth
The agency this week granted new emergency use authorizations to three tests, previously granted EUAs, so users can self-collect nasal swab samples while being observed by a healthcare provider remotely.
By Greg Slabodkin • July 17, 2020 -
Thermo Fisher ups Qiagen offer by 10% after investor backlash cites COVID-19 growth
The acquisition was announced weeks before the U.S. doubled down on its need for widespread coronavirus testing, which provided a big business opportunity for Qiagen that it capitalized on during the second quarter.
By Maria Rachal • July 16, 2020 -
Courtesy of BD/PRNewswire
BD sells 750K antigen tests to HHS as COVID-19 nursing home testing scales up
Also included in the government order are 2,000 of BD's point-of-care testing machines to be distributed starting next week in hotspot regions of the U.S.
By Maria Rachal • July 15, 2020 -
Courtesy of Quest Diagnostics
Quest COVID-19 test turnaround times double for priority patients
In an update late Monday, Quest said that while volumes have "stabilized," average turnaround times are still at least a week and some patients may have to wait for up to two weeks.
By Greg Slabodkin • Updated July 21, 2020 -
Courtesy of Qiagen
Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen
COVID-19 has made "significantly clearer" the importance of Qiagen's testing business, according to investment management firm Davidson Kempner, which is urging other shareholders to reject the offer priced in early March.
By Susan Kelly • July 13, 2020 -
Retrieved from Quest Diagnostics, PRNewswire on May 29, 2020
Quest Q2 better than feared, as demand surges for COVID-19 diagnostics
The update on April-through-June revenue comes as lab networks' July testing capacity and results turnaround times are strained by regional outbreaks.
By Maria Rachal • July 13, 2020 -
Shannon Muchmore/MedTech Dive
Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation
Eight organizations representing laboratory professionals asked the White House Coronavirus Task Force to address ongoing obstacles to performing tests.
By Greg Slabodkin • July 10, 2020 -
IVDR implementation by 2022 'highly doubtful,' trade group warns
MedTech Europe is ramping up calls for the European Commission to rethink plans for the roll-in of the In Vitro Diagnostic Regulation in light of the ongoing COVID-19 pandemic.
By Nick Paul Taylor • July 10, 2020 -
Courtesy of Abbott, PRNewswire
Siemens COVID-19 antibody test beats rivals in head-to-head study
Assays from Abbott, DiaSorin and Roche failed to meet the U.K. public health agency's sensitivity target. None of the tests performed as well as they did in the company-run studies quoted in their instructions for use.
By Nick Paul Taylor • July 10, 2020 -
Q2 previews show coronavirus diagnostics bump for Thermo Fisher, Quidel, GenMark
Preliminary results suggest near-insatiable demand for COVID-19 tests is offsetting disruption in other parts of the sector.
By Nick Paul Taylor • July 9, 2020 -
Philips wins $100M tele-ICU contract from VA
The company said it's creating the world’s largest system for providing remote access to critical care expertise, regardless of patient location.
By Nick Paul Taylor • July 9, 2020 -
Democrats urge Trump administration to force full payer coronavirus test coverage
The insurance lobby did not refute claims that not all testing is funded in full, particularly for return-to-work programs. Lawmakers said CMS guidance conflicts with legislation meant to spur widespread access to testing.
By Samantha Liss • July 8, 2020
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