Diagnostics: Page 2

FDA's 1st full OK to BioFire's COVID-19 test clears shorter path for others

Full agency approval of the diagnostic, now permitted to be marketed beyond the public health emergency, lets other companies secure non-emergency authorizations through a 510(k).

By Nick Paul Taylor • March 19, 2021

Abbott awarded $255M federal contract for rapid COVID-19 antigen tests

The company will initially provide 50 million of its point-of-care diagnostics to HHS for use in Florida and Maine, with the potential for up to $766 million under the eight-month deal.  

By Greg Slabodkin • March 18, 2021

Explore the Trendline➔

Trendline

The MedTech Dive Outlook on 2021

The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.

By MedTech Dive staff

Biden commits $12B for COVID-19 testing to reopen schools, address disparities

While not identifying company recipients, the administration called out both PCR tests that deliver results within 24 hours and point-of-care antigen kits as suitable for school screening programs.

By Nick Paul Taylor • March 18, 2021

Deep Dive

From labs to homes: where COVID-19 testing is headed in 2021

The U.S. appears to have reached a new phase in its battle against the coronavirus with vaccinations taking precedence over tests. Whether testing will return to earlier levels is an open question.

By Greg Slabodkin • March 17, 2021

FDA backs home use of COVID-19 tests without data in asymptomatic people

The move could benefit companies like Quidel, which aims to market an over-the-counter antigen test but has been held up by the need for more data on those without symptoms.   

By Nick Paul Taylor • March 17, 2021

FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions

The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.

By Nick Paul Taylor • March 17, 2021

1 year after COVID-19 hit: what's next for FDA, electives, testing and robotics

The medtech industry has ridden a roller coaster of steep demand for novel diagnostics and a plunge in once-stable business lines like hip and knee replacement surgeries.

Roche to buy GenMark for $1.8B to add multiplex testing

The Swiss company said the deal will give it access to a novel technology for testing a range of pathogens with one patient sample. William Blair analysts expect "potentially intense bidding wars" in the sector in coming months.

By Greg Slabodkin • March 15, 2021

Deep Dive

5 things medtech can expect from FDA in 2021

"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.

By Greg Slabodkin • March 15, 2021

FDA flags false positives from Roche's COVID-19-flu test

The agency is asking users who suspect their systems are suffering from either issue identified by the Swiss medtech giant to stop running tests on them and contact the company.

By Nick Paul Taylor • March 15, 2021

Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth

The lab giant's next move is to start selling an $89 at-home fecal test, targeting the colorectal cancer screening market led by Exact Sciences' Cologuard.

By Nick Paul Taylor • March 12, 2021

Quidel says COVID-19 test demand is plunging. Wall Street is underwhelmed.

CEO Doug Bryant said demand plummeted between 30% and 40% in February and March compared to the fourth quarter, sending shares down 17% on Wednesday.

By Greg Slabodkin • March 11, 2021

GE Healthcare predicts growth, hike in digital investment as pandemic eases

"We are seeing procedure volumes increasing, contributing to the rebound of our pharmaceutical diagnostics business and we see sequential market growth in imaging and ultrasound," CEO Kieran Murphy said during an investor event.

By Nick Paul Taylor • March 11, 2021

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

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

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 08, 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 08, 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 05, 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 03, 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 03, 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 02, 2021

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 01, 2021

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

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