Diagnostics

Early medtech Q3 results signal diagnostics boom, return to device growth

Johnson & Johnson and Edwards Lifesciences are among the device makers that staged significant recoveries in the most recent quarter, while Abbott, Thermo Fisher and Roche all reported dramatic gains from COVID-19 tests.

Neuromod devices at the fore in latest FDA breakthrough designations

Liquid biopsies also stand out as an area where U.S. regulators are encouraging development and prioritizing review.

By Nick Paul Taylor • Oct. 23, 2020

Quest revenue jumps 43% on COVID-19 tests, hands back federal funds

Execs said they now have a "clearer line of sight" into base business and coronavirus testing trends, but both remain "swing factors." Still, the lab giant raised its 2020 outlook and is returning $138 million in CARES monies.

By Greg Slabodkin • Oct. 22, 2020

Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

CEO Robert Ford argued that focusing on how coronavirus test demand will evolve "misses the point," touting the longer-term benefits of its now-expanded diagnostic platforms footprint.

By Maria Rachal • Oct. 21, 2020

Thermo Fisher's coronavirus tailwinds swell, outpacing Q3 analyst estimates

Sales of PCR test kits, instrumentation and viral transport media are all growing quickly enough to offset declines in the price of personal protective equipment and ongoing pressures on immunodiagnostics and transplant diagnostics.

By Nick Paul Taylor • Oct. 21, 2020

CMS coverage draft shuns 1st-to-market colorectal cancer blood test, outlines path for Exact, Guardant

The proposed Medicare coverage memo rejected Epigenomics' bid for payment, but Wall Street said the bar set was clearable by potential rival liquid biopsy developers working on similar products.  

By Maria Rachal • Oct. 20, 2020

Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high

CB Insights also listed the progress of neuromodulation devices and Medtronic's deals in diabetes and neurosurgery as other highlights.

By Nick Paul Taylor • Oct. 20, 2020

CMS to cut COVID-19 test pay by 25% for delayed results, labs cry foul

The American Clinical Laboratory Association, which includes LabCorp and Quest, argued the new policy fails to address the root of delays: fluctuating demand and supply chain disruptions.

By Nick Paul Taylor • Oct. 16, 2020

Roche diagnostics Q3 sales spiked 18% as COVID-19 offset routine test drop

Execs contend the momentum is sustainable even with arrival of a vaccine, citing government demand for high-throughput machinery and a shift in importance to antibody testing.

By Maria Rachal • Oct. 15, 2020

Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics

Non-coronavirus revenue saw a mid-single-digit drop and sales of a key TB test fell 20%. While those metrics improved from earlier in the year, Cowen analysts said the slump gives ammunition to doubters.

By Nick Paul Taylor • Oct. 14, 2020

J&J-backed Cue gets $481M to onshore production of rapid COVID-19 test kit

The startup will use the government funding to scale production to 100,000 COVID-19 test kits a day at its San Diego facilities.

By Nick Paul Taylor • Oct. 14, 2020

Cancer testing drives 2020 medtech IPO surge after slow start

A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.

By Nick Paul Taylor • Oct. 12, 2020

5 key exec insights from 2020's MedTech Conference

Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.

By Maria Rachal • Oct. 09, 2020

Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify

Shortages of test kits and other supplies persist, according to the labs polled by the Association for Molecular Pathology.

By Nick Paul Taylor • Oct. 09, 2020

FDA takes hands off EUA review for COVID-19 lab developed tests

The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."

By Greg Slabodkin • Oct. 08, 2020

Abbott, on defense, details embattled rapid COVID-19 test results

New data on the ID Now product comes amid criticism that the White House leaned too heavily on the quick-turnaround diagnostic, in light of President Donald Trump's illness and widespread West Wing infection.

By Nick Paul Taylor • Oct. 07, 2020

'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says

Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.

By Greg Slabodkin • Oct. 07, 2020

M&A on horizon as deep-pocketed medtechs eye distressed assets: EY

The combination of smaller companies questioning their pandemic survival and larger companies with considerable capital may spark a buying surge, the consultancy said in its annual medtech report.

By Nick Paul Taylor • Oct. 06, 2020

Ex-FDA chief Gottlieb questions White House reliance on Abbott COVID-19 test amid Trump diagnosis

"The Cepheid GeneXpert probably would be more fit to purpose. But, frankly, you'd need double layers of testing," President Donald Trump's former agency head said in a television appearance Sunday.

By Greg Slabodkin • Oct. 05, 2020

Quidel antigen test to detect COVID-19 and flu gets FDA nod

While Roche, Cepheid and LabCorp are among the companies offering combination tests, Quidel is the first to sell a fast-turnaround antigen-based option.

By Nick Paul Taylor • Oct. 05, 2020

Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets

The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.

By Nick Paul Taylor • Oct. 02, 2020

Deep Dive

5 ways COVID-19 is reshaping the medtech industry

Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.

By Maria Rachal , Greg Slabodkin • Oct. 01, 2020

COVID-19 spurred a medtech M&A boom this summer. Will it last?

Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear. 

By Nick Paul Taylor • Sept. 30, 2020

Data, supply chain constraints still dog COVID-19 testing, NIH officials say

Former heads of BARDA and NESTcc highlighted a need for comparing test types and protocols as the U.S. seeks to boost point-of-care options for asymptomatic and pre-symptomatic people.

By Maria Rachal • Sept. 29, 2020

6.5M Abbott COVID-19 antigen tests to reach states this week

Initial distribution of the rapid point-of-care diagnostics is meant to help reopen economies and schools, President Donald Trump said. It's still far short of the 200 million some experts say are needed each month.

By Greg Slabodkin • Sept. 29, 2020