Diagnostics: Page 43
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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 -
Courtesy of Stop Medical Distancing
LabCorp, McKesson back COVID-19 ad campaign urging patients to stop 'medical distancing'
The effort by a coalition of providers, payers and other firms is aimed at reviving elective procedures that were largely halted amid the pandemic.
By Shannon Muchmore • July 8, 2020 -
"White House Press Briefing". Retrieved from The White House.
As LabCorp, Quest feel COVID-19 strain, Trump admin pegs hopes on POC tests
Brett Giroir, the administration's lead for coronavirus diagnostics, said the goal is for rapid point-of-care tests from Abbott, BD and Quidel, performed outside of lab settings, to alleviate commercial testing capacity constraints.
By Greg Slabodkin • July 8, 2020 -
FDA warns of false positives with BD coronavirus diagnostic
On the heels of greenlighting BD's antigen test, FDA flagged an issue with its molecular test offering, telling healthcare professionals to treat positive results as “presumptive” and consider confirming findings via a different test.
By Nick Paul Taylor • July 7, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
BD launches coronavirus antigen test, 2nd to get FDA emergency use authorization
The rapid, point-of-care diagnostic joins Quidel's, which had been the only option in the category for nearly two months. Still, FDA notes antigen tests are more likely than molecular diagnostics to miss active coronavirus infections.
By Greg Slabodkin • July 6, 2020 -
CDC gets FDA nod for coronavirus-flu combination diagnostic
The emergency use authorization comes months after BioFire and Qiagen got backing for similar tests and as the coming flu season adds a new complexity to diagnosis.
By Nick Paul Taylor • July 6, 2020 -
Courtesy of Kroger
Kroger wins EUA for at-home coronavirus test kit
The grocer will make the home-collection kits available to employees this week and, along with partner Gravity Diagnostics, plans to process up to 60,000 tests weekly by the end of July.
By Jeff Wells • July 1, 2020 -
Notified body poll finds multi-month waits for COVID-19 conformity assessments
More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.
By Nick Paul Taylor • July 1, 2020 -
Alex Wong via Getty Images
HHS 'expects to renew' COVID-19 emergency, spokesperson says
The department did not respond to requests for comment Tuesday morning. The public health emergency is currently set to expire at the end of July.
By Shannon Muchmore • June 30, 2020 -
As Beckman enters US COVID-19 antibody market, how do rivals compare?
Comparing the accuracy of the Danaher subsidiary's test to products from big rivals like Abbott, Roche and Siemens Healthineers depends on who's doing the assessment and when a sample is taken.
By Nick Paul Taylor • June 30, 2020 -
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic
The medtech giant is betting remote adjustment will put its LUX-Dx insertable system in a position to take on rivals, which have a years-long head start.
By Nick Paul Taylor • June 29, 2020 -
Retrieved from Flickr.
Labs warn COVID-19 testing demand will soon top capacity as new hotspots emerge
With the spike in coronavirus cases in the South and West, commercial labs say they don't have the resources to keep up. Quest said in an update late Monday turnaround times for some molecular test results are now 3 to 5 days.
By Greg Slabodkin • Updated June 30, 2020
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