Americas drag on Qiagen as Thermo Fisher deal goes down to the wire

A hedge fund that owns 8% of Qiagen "fully" expects the Thermo Fisher offer to fail, calling it “wholly inadequate.”

By Nick Paul Taylor • Aug. 5, 2020

CMS proposes eliminating inpatient-only list, in potential boon for ASCs

The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

By Shannon Muchmore • Aug. 4, 2020

Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

By Maria Rachal • Aug. 3, 2020

Quidel says COVID-19 antigen test buoys 270% rise in rapid diagnostics unit, demand 'more than we can satisfy'

The company late Thursday reported second quarter total sales of $201.8 million, an 86% increase over the prior year, with strong demand for its PCR and antigen tests for the coronavirus.

By Greg Slabodkin • Updated July 31, 2020

Exact Sciences bets pandemic will accelerate adoption of Cologuard

The cancer diagnostics company is spending to drive a lasting move from colonoscopies to its at-home screening test, including running a $70 million TV advertising campaign.

By Nick Paul Taylor • July 31, 2020

Hologic blows away earnings expectations on COVID-19 testing surge

The manufacturer said it has ramped production capacity to at least 1.5 million coronavirus tests a week, estimating it provided a quarter to a third of the test results delivered in the U.S. during the recent quarter.

By Susan Kelly • July 30, 2020

Coronavirus could fuel clinical lab M&A by stressing smaller hospital players

Consultancy Kaufman Hall predicts a ramp-up of deals throughout the year, as hospital-owned labs seek support amid the pandemic. That forecast meshes with comments from Quest's CEO last week.

By Nick Paul Taylor • July 29, 2020

Hologic wins HHS-DOD contract to boost COVID-19 test supplies production

Some analysts peg Hologic's current share of the U.S. COVID-19 molecular testing market between 25% and 30% and predict the manufacturing expansion could create a $150 million windfall in quarterly revenue.  

By Susan Kelly • July 28, 2020

LabCorp says COVID-19 testing 'more than' offsets still-recovering base business

LabCorp's improving average turnaround time for reporting molecular diagnostic test results stands in contrast to Quest, which for most of July has reported average result wait times for non-priority patients of a week or more.

By Greg Slabodkin • July 28, 2020

Color targets supply, staffing bottlenecks with updated coronavirus test EUA

The population health technology company's test uses dry nasal swabs, eliminating the need for the viral transport media that's been in short supply and limited scaling by lab giants Quest and LabCorp.

By Nick Paul Taylor • July 28, 2020

Coronavirus testing hits a wall: Where do we go from here?

As LabCorp and Quest are backlogged in delivering molecular test results, some public health officials are calling for a shift in testing approach from slow and accurate to fast and good enough to meet demand.

By Greg Slabodkin • July 27, 2020

Medtech and COVID-19: 6 months into the public health emergency

MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

July 27, 2020

How COVID-19 is challenging and changing medtech supply chain management

Four experts share insights on the supply and demand hangups medtechs have been working through during the pandemic, and a few early takeaways the industry can carry forward.

By Maria Rachal • July 27, 2020

Diagnostics makers must plan for EUA products to have post-pandemic future

An extension to the public health emergency formalized a reprieve for emergency use authorizations, but manufacturers should act now if they want products to stay on the market when the crisis ends, compliance experts say.

By Greg Slabodkin • July 27, 2020

LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening

U.S. regulators simultaneously allowed the LabCorp test to be used in sample pooling, following the first such nod to a Quest Diagnostics test a week ago.

By Nick Paul Taylor • July 27, 2020

COVID-19 diagnostics emerging as prime investment target, SVB analysis shows

Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.

By Nick Paul Taylor • July 24, 2020

HHS renews COVID-19 public health emergency

The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.

By Shannon Muchmore • July 23, 2020

COVID-19 test demand backs 61% jump in Roche molecular diagnostic sales in 2020

"As far as the molecular diagnostics business is concerned, there is no doubt we will sell anything we can produce over the next half year,” Roche CEO Severin Schwan said on an earnings call with investors. 

By Nick Paul Taylor • July 23, 2020

Quest says COVID-19 hotspot spikes starting to hit routine testing recovery

In addition to soaring demand for coronavirus testing, the lab giant's Q2 was helped by gradual improvement in base testing volumes. But recent outbreaks have sent numbers down again in July.

By Greg Slabodkin • July 23, 2020

Medical device deal values down 88% amid COVID-19 disruption: PwC

Going forward, M&A may rise in light of recent deferral of elective procedures, which analysts say “could create the need for significant consolidation as companies work to remain competitive.”  

By Nick Paul Taylor • July 23, 2020

Thermo Fisher rakes in $1.3B in coronavirus-related Q2 revenue

The company expects momentum to continue in the third quarter after posting springtime results showing a more than 70% jump in its diagnostic and healthcare end market sales fueled by soaring demand for COVID-19 testing.

By Nick Paul Taylor • July 22, 2020

AdvaMed launches COVID-19 test registry to address shortages

Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.

By Nick Paul Taylor • July 22, 2020

4 healthcare sticking points as Congress weighs next coronavirus relief bill

Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.

By Rebecca Pifer , Samantha Liss • July 21, 2020

FDA eases rules on viral transport media to boost availability for COVID-19 testing

In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.

By Nick Paul Taylor • July 21, 2020

Quidel says its COVID-19 antigen test is now on par with PCR accuracy

Results suggest the product is more sensitive than a rival test sold by BD. Some analysts say that could help shore up concerns about the faster, point-of-care tests' accuracy. 

By Greg Slabodkin • July 20, 2020