Diagnostics: Page 33


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    Jacob Bell
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    FDA grants first EUA to at-home OTC molecular test for COVID-19

    Cue Health received the emergency authorization and expects to be able to produce more than 100,000 tests a day by the summer, as the agency continues to prioritize more at-home testing options.

    By March 8, 2021
  • Warchests, distressed assets drive medtech M&A flurry early in 2021

    The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.

    By March 5, 2021
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Jacob Bell
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    FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods

    The company, among a slew of recent designations granting enhanced feedback and speedier review, plans to file to run a pivotal trial of its Zenith Fenestrated+ Endovascular Graft this year.

    By March 3, 2021
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    Adobe Stock
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    Agilent strikes $550M Resolution buyout to muscle in on liquid biopsy space

    Analysts at Evercore ISI called the takeover of the company that competes with ArcherDX, Foundation Medicine and Guardant “extremely compelling,” calling it an attractive price to get into a fast-growing market.

    By March 3, 2021
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    Quidel, Eurofins get EUAs as at-home COVID-19 test market heats up

    The companies join Abbott, Ellume and Lucira with FDA-authorized offerings. A Craig-Hallum analyst called the emergency use authorization “the first step in morphing at-home testing into a multi-billion-dollar market.”

    By March 2, 2021
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Micrograph]. Retrieved from Flickr.
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    CMS moves to stop COVID-19 testing denials, cost sharing in private plans

    The trade group for Quest and LabCorp praised what it called “decisive action” by the Biden administration to close coverage gaps that have denied people access to tests.

    By March 1, 2021
  • Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). “Novel Coronavirus SARS-CoV-2” [Image]. Retrieved from Flickr.
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    UK industry pushes for pre- and post-vaccination roles for COVID-19 antibody tests

    The bid by Abingdon Health, CIGA Healthcare and Omega Diagnostics comes as Quest introduced a test to measure antibodies in the previously infected. Still, CDC does not recommend such testing to assess the need for vaccines.

    By Feb. 25, 2021
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    Retrieved from The White House/YouTube on January 21, 2021
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    ACLA urges Biden to fund uninsured COVID-19 testing, close coverage loopholes

    The plea from the trade group for Quest and LabCorp is the latest in a row between labs and insurers over paying for the diagnostics and comes as a $2 billion federal testing fund runs dry.

    By Feb. 24, 2021
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    Jacob Bell / BioPharma Dive
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    FDA lays path to weigh virus variant impact on COVID-19 test results

    The agency wants diagnostic companies to factor the potential for variants to evade detection into their test development and monitoring, Center for Devices and Radiological Health chief Jeff Shuren said.

    By Feb. 23, 2021
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    Jacob Bell
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    FDA starts review of how skin pigmentation affects pulse oximeter results

    The agency is evaluating published literature related to factors that may affect device accuracy and performance, following pressure from senators to address concerns that “racism may be embedded in key clinical tools.”

    By Feb. 22, 2021
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    Permission granted by Quidel Corporation
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    Quidel mulls entering new COVID-19 testing markets after another bumper quarter

    The point-of-care diagnostics maker sold $678.7 million in kits in the fourth quarter, up 81% sequentially, and is assessing whether it has the capacity to support antigen tests for retail, travel, entertainment and sports. 

    By Feb. 19, 2021
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    Dollar Photo Club
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    Exact Sciences-Guardant rivalry in colorectal testing market heats up

    Exact bolstered its play for the residual disease and recurrence segment by striking a deal to buy Ashion Analytics, while Guardant disclosed availability of its liquid biopsy test for the same market.

    By Feb. 17, 2021
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    One-third of US adults postponed care during pandemic: reports

    Among those surveyed, 25% put off dental care, while 21% put off checkups and 16% put off screenings or medical tests, researchers from the Urban Institute and RWJF found.

    By Ron Shinkman • Feb. 16, 2021
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    Getty Images
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    FDA admits COVID-19 antibody test policy was ‘flawed,’ offers lessons for future outbreaks

    Writing in the New England Journal of Medicine, agency officials acknowledged “touting the potential usefulness” of serology tests early in the pandemic contributed to flooding the market with poorly performing diagnostics.

    By Feb. 16, 2021
  • In run-up to MDR, EU posts guide to legacy devices in Eudamed

    The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.

    By Feb. 15, 2021
  • LabCorp warns COVID-19 testing sales could plummet as crisis abates

    The laboratory giant’s willingness to put a figure on the projected hit as vaccines take hold, in this case a dire 35% to 50% drop in revenues this year, contrasts with its chief rival Quest Diagnostics. 

    By Feb. 11, 2021
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    Jacob Bell
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    Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

    The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott’s ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge. 

    By Feb. 10, 2021
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    Courtesy of Qiagen
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    Qiagen shuns M&A that ‘dilutes’ its focus amid reports of Quidel merger

    Qiagen’s CEO said his business development team is focused on bolt-on acquisitions that support and strengthen its operations in five target areas.

    By Feb. 10, 2021
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    Jacob Bell / BioPharma Dive
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    Heart disease devices lead latest batch of FDA breakthrough nods

    The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche. 

    By Feb. 10, 2021
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    Permission granted by The Boldt. Co.
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    Alinity, da Vinci top hospital purchasing execs’ wish lists: UBS

    The feedback from hospitals’ purchasing executives, gathered in the fourth quarter of 2020, shows capital equipment budgets remain resilient in the face of COVID-19.

    By Feb. 9, 2021
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    Permission granted by Quidel Corporation
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    Report of Quidel-Qiagen tie-up makes ‘no sense,’ Wall Street analysts say

    Bloomberg reported the two companies are in early discussions. But while one analyst said it was a “plausible, though far-fetched” combination to create a global diagnostics firm, several questioned the wisdom of a union.

    By Feb. 9, 2021
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    Roundup: Medtech earnings season continues to show COVID-19 uncertainty

    BD, Quest Diagnostics and Roche all said they have a clearer view of the first quarter of 2021 but not the second half of the year, while Boston Scientific forecast electives pressure in the first quarter recovering in the second half.

    Feb. 5, 2021
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    Courtesy of Abbott Labs
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    Abbott antigen test cuts in-school COVID-19 infections in pilot study, but raises challenges

    One limitation noted by researchers looking at 6 U.S. cities: “While we can hypothesize that antigen tests can solve the cost and time limitations of PCR testing, we have no idea how well the tests work in children.” 

    By Feb. 5, 2021
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    Courtesy of Roche
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    Roche diagnostics revenues up 28% fueled by COVID-19 antigen test demand

    “The first half year is very clear. This is where we have most of our ... COVID sales for 2021. And then in the second half year, we’ll see how certain things develop,” the unit’s CEO Thomas Schinecker told investors.

    By Feb. 4, 2021
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Coronavirus uncertainty clouds Quest’s 2d half amid Q4 revenue bump

    CEO Steve Rusckowski said he expects 2021 to be a strong year for COVID-19 testing, but the lab network predicts demand will likely decline throughout the year as more people are vaccinated.

    By Feb. 4, 2021