Diagnostics

Diagnostics makers ride omicron surge in COVID-19 test demand. But for how long in 2022?

The highly transmissible variant caused the Biden administration to announce plans to buy 1 billion rapid tests to provide free to Americans. However, when testing will ramp back down remains an open question.  

By Greg Slabodkin • Jan. 20, 2022

Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.

By Nick Paul Taylor • Jan. 20, 2022

Explore the Trendline➔

COVID-19 diagnostics surge as industry prepares for spike in at-home testing

With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

By MedTech Dive staff

FDA misses MDUFA V deadline after months of contentious talks

The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

By Nick Paul Taylor • Jan. 19, 2022

Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing

The three test makers said at last week's J.P. Morgan healthcare conference that they see opportunities for direct-to-consumer, digitally-connected testing for other diseases beyond COVID-19.

By Greg Slabodkin • Jan. 18, 2022

Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

By Greg Slabodkin • Jan. 14, 2022

Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB

In a new report, Silicon Valley Bank projects that medical device mergers and acquisitions "will stay hot, as a diverse set of acquirers compete for the top deals," but sees a slowdown in initial public offering activity.

By Nick Paul Taylor • Jan. 14, 2022

Neurological devices, diagnostics dominate latest FDA breakthrough designations

The agency has granted breakthrough designations to several devices for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.

By Nick Paul Taylor • Jan. 13, 2022

Notified body shortage remains pressing as industry prepares for staggered IVDR rollout

Three months have passed since the European Commission warned about a "grave shortage of notified body capacity," but the situation is largely unchanged.

By Nick Paul Taylor • Jan. 13, 2022

Biden health officials defend COVID-19 testing policies amid diagnostics shortage

Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.   

By Greg Slabodkin • Jan. 12, 2022

Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Hologic tops guidance as COVID-19 testing wave delivers another beat

The test maker said it will comfortably beat first-quarter guidance, with demand for coronavirus diagnostics helping the company post preliminary revenues of almost $1.5 billion. Quidel set the tone last week with its own beat. 

By Nick Paul Taylor • Jan. 10, 2022

Quidel preliminary Q4 revenue beats Street on COVID-19 test sales

Fourth-quarter revenue was more than 35% above the consensus analyst estimate, though it was still down from Quidel's 2020 strong final quarter.

By Nick Paul Taylor • Jan. 7, 2022

Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron

A small real-world study, which has yet to be peer reviewed, found the rapid tests may fail to detect some omicron cases during the first days of infection.

By Nick Paul Taylor • Jan. 6, 2022

Quest's COVID-19 test results turnaround hits longest wait since 2020

The lab giant is taking an average of two to three days to deliver results for molecular diagnostic tests amid the omicron surge, compared to the one-day turnaround time it achieved throughout most of 2021.

By Nick Paul Taylor • Jan. 6, 2022

Medtechs brace for hit as hospitals warn of omicron impact on surgeries

Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.

By Nick Paul Taylor • Jan. 5, 2022

Medtech's biggest deals in 2021 and what to expect next

After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale. 

By Susan Kelly • Jan. 4, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

Quidel to buy Ortho Clinical Diagnostics in $6B deal; stock tanks

CEO Doug Bryant said the combined company will have a "broader geographic footprint" thanks to Ortho's reach across 130-plus countries. Quidel's shares fell by as much as 17.8% in Thursday morning trading.

By Greg Slabodkin • Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021

CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue

The FDA's Center for Devices and Radiological Health expects "a gradual transition back toward normal review timelines" next year as COVID-19 has delayed traditional work.

By Nick Paul Taylor • Dec. 22, 2021

Biden stresses need for additional testing supply, plans to distribute 500M free rapid COVID-19 tests

"We have to do more. We have to do better — and we will," President Joe Biden acknowledged on Tuesday, as a surge in omicron cases has put added stress on America's already strained test supply.

By Greg Slabodkin • Updated Dec. 22, 2021

Most COVID-19 medical device EUAs lack documented supporting data: JAMA

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 21, 2021

EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply

MedTech Europe welcomed the adoption of the amended transitional provisions, which it said mitigate "the immediate and urgent risk" of disruption.

By Nick Paul Taylor • Dec. 21, 2021

Roundup: Omicron variant's impact on COVID-19 tests

As the variant of concern continues to spread worldwide, FDA and test makers have scrambled to assess whether the performance of diagnostics are affected by omicron's viral mutations. Here's what we know so far.  

Updated Dec. 29, 2021

FDA in update says 2 COVID-19 tests fail to detect the omicron variant

Diagnostics from Applied DNA Sciences and Meridian Bioscience are not able to detect omicron, causing false negative results, according to the agency, while Tide Laboratories has fixed the problem with its test.

By Greg Slabodkin • Updated Dec. 29, 2021