Diagnostics: Page 35
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Thermo Fisher, PerkinElmer broaden COVID-19 mutation tracking products
The companies will sell PCR assays to labs to enable surveillance, coming amid warnings that the U.S. is "flying blind" when it comes to tracking rapidly emerging SARS-CoV-2 variants.
By Greg Slabodkin • March 10, 2021 -
Courtesy of BD/PRNewswire
BD, Abbott using apps to ease COVID-19 antigen test data bottlenecks
Both companies are using apps to capture and store testing data with public health agencies. The U.S. government has invested hundreds of millions of dollars to increase antigen testing, but data sharing hurdles remain.
By Nick Paul Taylor • March 10, 2021 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
EU remote audits under MDR in doubt as divergent national positions persist
Team-NB pulled a proposal unveiled in February amid sustained resistance. A Commission medical device group met last week but has yet to disclose a solution.
By Nick Paul Taylor • March 10, 2021 -
Coronavirus relief bill with rural hospital aid, over $47B for testing passes Senate
The nearly $2 trillion bill includes $47.8 billion to boost COVID-19 testing and contact tracing efforts, including supporting the development, manufacturing and administering of tests.
By Shannon Muchmore • March 8, 2021 -
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 Nick Paul Taylor • 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 Nick Paul Taylor • March 5, 2021 -
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 Nick Paul Taylor • March 3, 2021 -
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 Nick Paul Taylor • March 3, 2021 -
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 Nick Paul Taylor • March 2, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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 Nick Paul Taylor • March 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
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 Nick Paul Taylor • Feb. 25, 2021 -
Retrieved from The White House/YouTube on January 21, 2021
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 Nick Paul Taylor • Feb. 24, 2021 -
Jacob Bell/MedTech Dive
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 Nick Paul Taylor • Feb. 23, 2021 -
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 Nick Paul Taylor • Feb. 22, 2021 -
Permission granted by Quidel Corporation
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 Nick Paul Taylor • Feb. 19, 2021 -
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 Nick Paul Taylor • Feb. 17, 2021 -
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 -
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 Nick Paul Taylor • 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 Nick Paul Taylor • 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 Nick Paul Taylor • Feb. 11, 2021 -
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 Greg Slabodkin • Feb. 10, 2021 -
Courtesy of Qiagen
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 Nick Paul Taylor • Feb. 10, 2021 -
Jacob Bell/MedTech Dive
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 Nick Paul Taylor • Feb. 10, 2021 -
Permission granted by The Boldt. Co.
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 Susan Kelly • Feb. 9, 2021 -
Permission granted by Quidel Corporation
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 Greg Slabodkin • Feb. 9, 2021
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