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

Explore the 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

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

Cold War law invoked for BD, Quidel to prioritize antigen test contracts

The Trump administration's use of the Defense Production Act comes amid rising demand for the tests that can be less accurate than traditional molecular diagnostics, but offer results within minutes.

By Nick Paul Taylor • Aug. 21, 2020

House panel demands HHS briefing on decision to nix premarket review for COVID-19 lab developed tests

On Thursday, Energy and Commerce Chairman Frank Pallone, D-N.J., insisted the department explain its "deeply concerning" decision to allow coronavirus LDTs to come to market without FDA review.

By Greg Slabodkin • Updated Aug. 21, 2020

IDx rebrands, buys 3Derm to expand automated AI portfolio

The takeover gives the company, now known as Digital Diagnostics, control of two breakthrough device-designated autonomous artificial intelligence systems.

By Nick Paul Taylor • Aug. 20, 2020

LumiraDx lands FDA's third COVID-19 antigen test EUA, as demand for rapid diagnostics rises

William Blair analysts questioned the immediate impact from the nod to the relatively small medtech, and instead looked ahead to the next potential big player to enter the market: Abbott.

By Nick Paul Taylor • Aug. 20, 2020

Why it's taken Quest so long to clear its COVID-19 testing backlog

The lab giant trailed chief rival LabCorp in turnaround times for most of July, slowed down by geography and the makeup of its customer base. Quest finally caught up this week, reporting average test results in one to two days.

By Greg Slabodkin • Aug. 18, 2020

FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic

The Defense Production Act allows private companies to enter agreements with the government while avoiding antitrust liability. AdvaMed wants to participate but FEMA has not yet extended an invite.

By Greg Slabodkin • Aug. 18, 2020

Thermo Fisher COVID-19 test flagged for false positive and negative results

An FDA alert on Monday follows a quarter in which coronavirus-related products added $1.3 billion to the medtech's sales, and after it scored an HHS contract to provide processing instruments to labs.

By Nick Paul Taylor • Aug. 18, 2020

Abbott, Roche COVID-19 antibody tests may mislead on immunity, study suggests

The MD Anderson study is the latest to question the value of such tests and note the risk they may lead people to incorrectly believe they are immune from further infection.

By Greg Slabodkin • Aug. 17, 2020

FDA OKs Yale COVID-19 saliva test removing RNA extraction step

While the agency called the method potentially groundbreaking, one public health expert cautioned that the assay must be performed in highly specialized labs and is not considered a rapid test.

By Nick Paul Taylor • Aug. 17, 2020

HHS commits $6.5M to add Thermo Fisher, Beckman Coulter COVID-19 test supplies to Aegis, Sonic labs

The federal funding to scale testing, still dwarfed by government spending on vaccines, came the same week labs and providers urged the administration to update testing prioritization guidelines given limited resources.

By Greg Slabodkin • Aug. 14, 2020