Quidel shakes Wall Street with bearish COVID-19 test forecast

The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.

By Greg Slabodkin • April 23, 2021

Science groups urge caution against using certain COVID-19 test data

The Association for Molecular Pathology and the Infectious Diseases Society of America say relying on cycle threshold (Ct) values runs the risk of being misinterpreted due to a lack of standardization across test methods.

By Susan Kelly • April 23, 2021

Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes

CEO Steve Rusckowski told investors Thursday the lab giant's routine business continued its recovery to near pre-pandemic levels, helping offset coronavirus diagnostics coming in below estimates.

By Greg Slabodkin • April 22, 2021

Moody's predicts brisk pace of medtech M&A amid earnings optimism

A new report from the ratings agency echoes initial commentary by bellwethers J&J and Edwards, which released financials this week.

By Susan Kelly • April 22, 2021

Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty

The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.

April 22, 2021

Intuitive sees Q1 robot rebound in turnabout from start of year

CEO Gary Guthart called the quarter a "step in the right direction," but execs also cautioned variants and supply chain constraints could throw a wrench into the recovery.

By Susan Kelly • April 21, 2021

Edwards withstands winter lows, grows Q1 sales on electives recovery

CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.

By Ricky Zipp • April 21, 2021

Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics

Roche Diagnostics CEO Thomas Schinecker predicted second-quarter coronavirus sales would also be healthy, continuing into the third quarter.

By Greg Slabodkin • April 21, 2021

Health funding shatters records in Q1, but medtech a bit of a laggard

Medical device companies were a relative outlier, raising $4.6 billion, down 23% from a peak in the fourth quarter last year, while the number of deals declined by almost 11%, according to a CB Insights report.

By Rebecca Pifer • April 20, 2021

Abbott misses Wall Street as COVID-19 test sales softer than expected

CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now." 

By Greg Slabodkin • April 20, 2021

J&J returns to growth in Q1 as elective care rebounds in US, Asia-Pacific

The recovery was mixed among procedure types, with hips improving, while knees and spine fell. Still, CEO Alex Gorsky forecast volumes to keep rebounding throughout 2021.

By Ricky Zipp • April 20, 2021

6 medtechs to watch when earnings kick off next week

First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines. 

By Nick Paul Taylor • April 15, 2021

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

The US paused use of J&J's vaccine. What happens next?

A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.

By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • 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

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

Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll

The 200 U.S. physicians surveyed by UBS analysts expect the medtech to pick up share in knees and hips but are downbeat on the prospects of Smith & Nephew in both of the segments.

By Nick Paul Taylor • April 9, 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 9, 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 8, 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 6, 2021

Digital health funding hits new high after Q1 rich in megadeals

U.S. digital health companies raised a record $6.7 billion in the first quarter of 2021, putting the industry on track to easily top the $14 billion in investment last year.

By Nick Paul Taylor • April 6, 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 1, 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 1, 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