Cellex, Gauss ally to develop fully at-home, app-enabled COVID-19 antigen test

The first company to receive an FDA nod for a coronavirus antibody test is pairing its 15-minute antigen test with a smartphone app to automate interpretation of results. There might be a higher likelihood of false negatives.

By Nick Paul Taylor • Sept. 17, 2020

Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher

But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.

By Nick Paul Taylor • Sept. 17, 2020

Explore the Trendline➔

New 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

Roche gets FDA nod for faster combo coronavirus-flu test

The diagnostic, designed to detect and differentiate SARS-CoV-2 and influenzas A and B, gives results within 20 minutes, compared to a prior authorized version for a Roche system with an hours-long turnaround.

By Greg Slabodkin • Sept. 16, 2020

BD probes COVID-19 false positives with point-of-care systems

The medtech's antigen tests have spurred demand from the federal government and states, but may be turning up incorrect results in nursing homes, The Wall Street Journal reported and the company confirmed Tuesday morning.

By Maria Rachal • Sept. 15, 2020

After uneven start to 2020, Hologic becomes Wall Street darling

An update Friday from the medtech that organic year-over-year revenue growth may reach 60% this quarter impressed some analysts, many of whom see capitalization in the COVID-19 environment being sustainable.

By Maria Rachal • Sept. 14, 2020

Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020

The company forecasts significantly higher growth this year than it's posted in the past, despite suffering a slow first quarter due to early disruption from the pandemic.

By Nick Paul Taylor • Sept. 11, 2020

Quest raises 2020 revenue outlook to beat pre-coronavirus goal by 10%

Despite worries that summer coronavirus hotspots could reverse the recovery for routine testing, the lab network said base volumes grew faster than expected through August.

By Maria Rachal • Sept. 10, 2020

BD says its antigen test on par with Quidel's in head-to-head preprint study

The state of Maryland announced Thursday it bought 250,000 of the BD tests, which the company contends have shown equivalent performance to Quidel's despite a difference in earlier published sensitivity claims.

By Greg Slabodkin • Sept. 10, 2020

LabCorp, DiaSorin tests differentiate COVID-19, flu, RSV

The companies join test developers including Roche, Qiagen, BioFire Diagnostics and Novacyt in preparing combination tests to tackle the challenges of the upcoming influenza season.

By Susan Kelly • Sept. 9, 2020

Grail files for $100M IPO ahead of 2021 launch of multi-cancer liquid biopsy

The Illumina spinout contends its Galleri test could avert 39% of deaths from cancers that would otherwise kill within five years, but acknowledges the challenge of getting payer support for asymptomatic screening.

By Nick Paul Taylor • Sept. 9, 2020

Roche COVID-19, flu combo test gets FDA emergency authorization

It is the fourth EUA for a diagnostic that detects and differentiates the viruses. However, the company claims to be the first commercial test that runs on fully automated high-throughput systems using a single sample.

By Greg Slabodkin • Sept. 4, 2020

NIH awards $129M to scale up US COVID-19 testing capacity

Illumina, Sonic Healthcare and PathGroup are among recipients of the funds with a goal to handle 454,000 tests a day. However, the country needs millions more daily tests above current levels. 

By Nick Paul Taylor • Sept. 3, 2020

Final inpatient payment rule confirms price transparency push

The American Hospital Association quickly criticized the CMS decision to move forward with collecting data on hospital median payer-specific negotiated charges to guide relative Medicare payment rates.

By Hailey Mensik • Updated Sept. 3, 2020

Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results

Gov. Ron DeSantis ordered all Florida agencies to sever testing relationships with the lab giant, which apologized for the delay in getting data to state health authorities in the timely manner required by law.

By Susan Kelly • Sept. 2, 2020

Roche set to launch rival to Abbott's rapid COVID-19 antigen test

The diagnostics giant expects to make 40 million of the instrument-free tests a month when it launches in late September and more than double that by the end of 2020, but doesn't yet have emergency authorization from FDA.

By Nick Paul Taylor • Sept. 2, 2020

UK outlines post-Brexit medical device regime starting January

Regulators unveiled a future U.K. Conformity Assessed (UKCA) mark, but will continue recognizing CE marks until mid-2023 and give companies four to 12 months to register their devices and in vitro diagnostics.

By Nick Paul Taylor • Sept. 2, 2020

HHS backs COVID-19 antigen testing for nursing homes, preempting regional restrictions

Although some state and local authorities are concerned about the accuracy of such rapid diagnostics, sold by Abbott, BD and others, the move comes amid rising calls for their use to test large numbers of people.

By Nick Paul Taylor • Sept. 1, 2020

Comparisons of COVID-19 saliva, swab tests paint mixed picture

Study findings published the same day in the New England Journal of Medicine and Annals of Internal Medicine have conflicting messages on saliva tests, which FDA has greenlit from developers including Fluidigm and Phosphorus.

By Nick Paul Taylor • Aug. 31, 2020

Abbott gets $760M contract from HHS to deliver 150M antigen tests

The deal comes just one day after the company's antigen test received FDA emergency use authorization. BD, Quidel and LumiraDx previously got the agency's nod for their diagnostics.

By Greg Slabodkin • Aug. 28, 2020

Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

By Greg Slabodkin • Aug. 27, 2020

Abbott gets EUA for rapid $5 COVID-19 antigen test

As the fourth company to get the FDA emergency nod, the medtech giant's scale makes it a "significant entry [that] could help democratize testing," said former agency head Scott Gottlieb.

By Nick Paul Taylor • Aug. 27, 2020

Freenome raises $270M to run pivotal trial of colorectal cancer liquid biopsy

The 14,000-subject study could set the company up to compete with Exact Sciences and Guardant Health for the colorectal cancer screening market.

By Nick Paul Taylor • Aug. 26, 2020

FDA-industry group touts real-world evidence framework to speed test development

The Medical Device Innovation Consortium, a collaboration between FDA and diagnostics makers like Abbott and Roche, offers a roadmap as COVID-19 accelerates use of newly generated data to update emergency authorizations. 

By Susan Kelly • Aug. 25, 2020

MedTech Europe beats drum for virtual audits, IVDR delay

The one-year delay to the EU Medical Device Regulation has been crucial, but there's been "radio silence" from lawmakers on calls for a similar delay to the In Vitro Diagnostic Regulation, said regulatory lead Oliver Bisazza.

By Maria Rachal • Aug. 24, 2020

Ex-Trump FDA chief rails against new HHS policy on lab developed tests

Scott Gottlieb took to Twitter on Saturday criticizing last week's decision by the administration that FDA will no longer require premarket review of LDTs. "FDA’s ability to protect public health could be challenged," he warned. 

By Greg Slabodkin • Aug. 24, 2020