Diagnostics

Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll

The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.

By Nick Paul Taylor • April 14, 2021

Lucira gets FDA nod for OTC molecular COVID-19 test

The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.

By Nick Paul Taylor • April 13, 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

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021

Italy's DiaSorin buys Luminex in $1.8B deal for multiplex molecular testing assets

The takeover comes weeks after Roche agreed to pay $1.8 billion to buy GenMark Diagnostics for its multiplex testing capabilities. The two targets compete with BioFire and Quidel.

By Nick Paul Taylor • April 12, 2021

Hologic pens $795M Mobidiag buyout to expand in acute care testing

Wall Street analysts cheered the move, with Evercore ISI writing "it fills a major hole in the company's armament." The deal marks Hologic's fourth pick-up of 2021, including the $230 million takeover of Biotheranostics in January.

By Nick Paul Taylor • April 09, 2021

LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price

The COVID-19 test maker hopes to generate enough capital to pursue a point-of-care testing opportunity it values at $76 billion. It has a ways to go to deliver.

By Nick Paul Taylor • April 08, 2021

FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

By Nick Paul Taylor • April 07, 2021

Fewer heart tests ordered for telehealth patients in pandemic

Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.

By Susan Kelly • April 06, 2021

Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing

The medical genetics company expects Genosity's capabilities to increase access to its cancer test and reduce turnaround time, while a sizable investment led by SoftBank will support growth initiatives.

By Nick Paul Taylor • April 06, 2021

UCLA engineer calls for mitigation of biases of medical devices

The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.

By Nick Paul Taylor • April 05, 2021

Liquid biopsies dominate FDA's latest breakthrough device nods

Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.

By Nick Paul Taylor • April 05, 2021

Abbott, BD, Quidel tests get EUAs for asymptomatic COVID-19 serial screening

While the Abbott and Quidel authorizations are for over-the-counter use, BD's test requires a prescription, which "along with the fact an instrument is needed, limits the use-cases for the company significantly," William Blair analysts wrote.

By Greg Slabodkin • April 01, 2021

Quest sells minority share of Q2 Solutions for $760M

IQVIA, which previously owned 60% of Q2 Solutions, will now become the sole owner of the clinical trials laboratory company. Quest and IQVIA established Q2 Solutions as a joint venture in 2015.

By Ricky Zipp • April 01, 2021

A year into the pandemic, advanced cancer diagnoses are rising

Research from radiation oncologists and molecular pathologists add to evidence showing that many people skipped getting cancer screenings in 2020 as they avoided going to the doctor to minimize the risk of COVID-19 infection.

By Susan Kelly • March 31, 2021

FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products

A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests.

By Nick Paul Taylor • March 31, 2021

FTC challenges Illumina-Grail deal, putting $7B merger in jeopardy

The commission said the union will "harm competition in the U.S. market for life-saving multi-cancer early detection tests." Illumina is opposing the action, but Wall Street analysts see no "easy fixes."

By Nick Paul Taylor • March 31, 2021

Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund

A who's who of sector companies are teaming with the Rockefeller Foundation on the proposal. The industry stands to benefit from widespread school testing as symptomatic demand diminishes.

By Nick Paul Taylor • March 26, 2021

Thermo Fisher pivots COVID-19 approach with air detection, school testing

The company is looking to new strategies as vaccines drive down cases and institutions like schools, hospitals and businesses re-open.

By Nick Paul Taylor • March 25, 2021

Roche bets COVID-19 vaccination drive to favor PCR over antigen testing

Wall Street analysts contend the Swiss diagnostic company's argument could bode well for Abbott, Hologic, Thermo Fisher Scientific and PerkinElmer.

By Nick Paul Taylor • March 24, 2021

Cancer screenings bounced back after steep pandemic declines, Rand report shows

The rate of women seeking mammograms was higher by the end of July than in the months leading up to the pandemic, though colonoscopies did not return to pre-pandemic levels, researchers found.

By Samantha Liss • March 23, 2021

EU group proposes minimum standards for rapid antibody COVID-19 tests

Antibody tests of questionable accuracy proliferated on both sides of the Atlantic early in the pandemic, leading the U.S. and European Union to try to raise standards. 

By Nick Paul Taylor • March 19, 2021

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

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