Diagnostics: Page 44


  • Image from the Stop Medical Distancing ad campaign
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    Courtesy of Stop Medical Distancing
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    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
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    "White House Press Briefing". Retrieved from The White House.
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    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 July 8, 2020
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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    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
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    Jacob Bell
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    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 July 7, 2020
  • Medical technicians process specimens at a COVID-19 Community-Based Testing Site at the PNC Bank Arts Center in Holmdel, N.J., March 23, 2020. The testing site, established in partnership with the Fed
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    Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
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    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 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 July 6, 2020
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    Courtesy of Kroger
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    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 July 1, 2020
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images
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    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
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    Jacob Bell
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    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 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 June 29, 2020
  • Members of the Navy’s preventative medicine team both assigned to Navy Environmental Preventative Medicine Unit Six, test samples in a BioFire Film Array, which will test for nearly 30 different disea
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    Retrieved from Flickr.
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    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 Updated June 30, 2020
  • Payer coverage of employer, surveillance COVID-19 tests not required, feds say

    As return-to-work offerings proliferate from lab and pharmacy giants like Quest, LabCorp and CVS, new federal guidance says health insurers aren't obligated to pay for the testing services.

    By Maria Rachal • June 25, 2020
  • UK study to validate, compare COVID-19 tests in real-world settings

    The hospital arm will assess 10 to 20 new diagnostics the National Health Service has identified as high priority, including those designed to deliver results at the point of care in minutes, which could include Abbott’s ID NOW.

    By June 25, 2020
  • House Energy and Commerce hearing on COVID-19 June 23 2020
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    Screenshot of House E&C hearing, June 23, 2020

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    Fauci: Trump never asked to slow down testing, says US needs more, not less

    During a House panel Tuesday, top U.S. infectious disease doctor Anthony Fauci and other public health officials denied they'd been directed to impede testing efforts as the White House targets up to 50 million tests a month by fall.

    By Rebecca Pifer • June 24, 2020
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    "Florida National Guard" by The National Guard is licensed under CC BY 2.0
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    5-minute, quantitative COVID-19 antibody test snags BARDA backing

    MBio's offering could assess whether a patient has protective levels of antibodies and is a candidate to donate convalescent plasma, a potential treatment for critically ill COVID-19 patients.

    By June 24, 2020
  • CVS launches COVID-19 return-to-work service with testing

    Questions about testing accuracy and hesitancy by employers haven't stopped big healthcare companies, including Quest, LabCorp and UnitedHealth Group, from jumping into the space with new products.

    By Rebecca Pifer • June 24, 2020
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    Getty / Edited by BioPharma Dive
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    New Guardant genomic database could be worth $2B, analysts say

    The company said clinical information from repeat liquid biopsies in its 86,000-patient database will show how tumors evolve, information that may be attractive to biopharma partners.

    By June 24, 2020
  • Members of the Army and Air National Guard from across several states have been activated under Operation COVID-19 to support federal, state and local efforts. (
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    The image by The National Guard is licensed under CC BY 2.0
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    Deep Dive

    No silver bullet: LabCorp and Quest hawk return-to-work COVID-19 tests but employers not rushing in

    One employer group official noted "hype" around antibody testing with inconclusive evidence about the immunity of individuals who test positive for the antibodies. 

    By June 22, 2020
  • BARDA backs study of Empatica's COVID-19 early warning platform

    The system, which measures physiological data including blood volume pulse and electrodermal activity, is the latest in a growing list of wearables being primed to detect and monitor infections.

    By June 22, 2020
  • Trump admin sitting on $14B for testing, tracing, Democratic senators say

    A letter urging the administration to ramp up its COVID-19 spending comes a day after President Donald Trump told a rally he had directed officials to slow down testing to keep case numbers low.

    By Rebecca Pifer • June 22, 2020
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    Dollar Photo Club
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    Invitae cash-and-stock buyout of ArcherDX a done deal

    The medical genetic testing company swept in after the assay developer announced plans to go public. Invitae will now offer tests for more stages of cancer care, from assessing disease risk to monitoring its progression.

    By Maria Rachal • Updated Oct. 5, 2020
  • President Trump listens as FDA Commissioner Stephen Hahn delivers remarks at COVID-19 update briefing on April 24, 2020
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    Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
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    Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says

    The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.

    By Maria Rachal • June 19, 2020
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    Jacob Bell / BioPharma Dive
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    FDA cracks down on sellers of at-home COVID-19 antibody tests

    A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.

    By June 18, 2020
  • TÜV SÜD becomes 4th notified body designated under IVDR

    It's the first notified body OK'd by the European Commission in 2020 to increase capacity for the forthcoming In Vitro Diagnostic Regulation, set to come into force in less than two years.

    By June 18, 2020
  • FDA revokes emergency authorization for Chembio's COVID-19 antibody test

    It's the first time the agency has exercised such authority for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.

    By June 17, 2020