Health insurers, labs point fingers over COVID-19 test coverage and prices

An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs. 

By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020

FDA OKs first fully at-home COVID-19 test as US cases surge

An emergency use authorization to biotech Lucira Health comes as some experts say the tests could help significantly boost capacity. Others say that's a long way off, and call for more guidance from regulators on proper use.

By Greg Slabodkin • Nov. 18, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests

Testing czar Brett Giroir has reversed FDA's decision to no longer review emergency use authorization requests for LDTs so that university labs can secure EUAs and get liability protection under the PREP Act.

By Greg Slabodkin • Nov. 17, 2020

EU regulators provide 7 rules for classifying diagnostics under IVDR

The European Commission's Medical Device Coordination Group placed IVDs into different risk categories based on how they will be used. Only one class can be self-certified.

By Nick Paul Taylor • Nov. 16, 2020

Labs face COVID-19 surges, warn of test result delays as CMS pay cuts loom

The American Clinical Laboratory Association sounded an alarm over nationwide capacity constraints, which may increase average time to results.

By Maria Rachal • Nov. 13, 2020

Quidel on defense after COVID-19 vaccine spurs questions of reduced testing demand

The company's stock has been under pressure following positive vaccine results. CEO Doug Bryant argued Thursday the demand for tests is "endless."

By Greg Slabodkin • Nov. 13, 2020

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes

The company claims 90% sensitivity, whereas other antigen tests sold by Abbott, Roche and Quidel have reported sensitivities of around 97%.

By Nick Paul Taylor • Nov. 12, 2020

Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

UK fleshes out post-Brexit approach to regional medical device marking

The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.

By Nick Paul Taylor • Nov. 11, 2020

Abbott COVID-19 tests at center of squabble between Trump administration, states

HHS testing czar Brett Giroir on Monday said the government is halting the antigen test shipments to eight states until those already sent are distributed and used. At least one state pushed back on his assertions.

By Greg Slabodkin • Nov. 10, 2020

Quidel, Hologic, other test stocks sink as vaccine result brings hope for pandemic's end

The declines Monday, led by a 28% drop at Quidel, reflect concerns that availability of an effective COVID-19 vaccine will tamp down on the multibillion-dollar testing boom.

By Nick Paul Taylor • Nov. 10, 2020

What Intuitive is looking for through its new $100M venture fund

Surgical robots have been Intuitive's sweet spot. As the company moves into VC for the first time, its broader focus on minimally invasive care, including interest in digital tools and precision diagnostics, opens more opportunities.

By Maria Rachal • Nov. 9, 2020

Biden transition team names COVID-19 advisers, seeks dramatic testing scale-up with federal approach

The president-elect calls for doubling drive-through test sites and increasing capacity by "orders of magnitude" through investing in rapid at-home tests. The transition team has already called in help from former FDA and BARDA heads.

By Greg Slabodkin • Nov. 9, 2020

GenScript wins 1st FDA nod to test for antibodies that could neutralize COVID-19

The Hong Kong-listed biotech's offering differs from earlier EUAs for serology tests from Abbott, Roche and Siemens Healthineers that only screen for antibodies that do not necessarily cut viral infection.

By Susan Kelly • Nov. 9, 2020

Guardant beats expectations but warns COVID-19 surges will hurt Q4 growth

On a more optimistic note, the blood test developer expects the recent FDA approval for its Guardant360 tumor profiling liquid biopsy will increase its CMS payment rate and expand reimbursement among private payers.

By Nick Paul Taylor • Nov. 6, 2020

Patients shirked diagnostic testing, in-person preventive care amid telehealth boom this spring

Routine preventive services that can't be done virtually, such as mammograms and colonoscopies, plunged 65% in March and April compared to the year prior, according to an analysis published in JAMA Network Open.

By Hailey Mensik • Nov. 5, 2020

Even if Biden wins, divided Congress stifles chance for more progressive health policies

Results of the election are not final and may be uncertain for weeks, but the most likely scenario points to mostly incremental change, a positive for many parts of the healthcare sector.

By Shannon Muchmore • Nov. 5, 2020

BD returns to growth on COVID-19 antigen tests, but predicts price erosion

The company said sales related to its rapid testing could hit $1.5 billion next year, with the prospect of demand continuing into 2022. However, management thinks Abbott's $5 test could drive down its pricing.

By Nick Paul Taylor • Nov. 5, 2020

Hologic bets on COVID-19 molecular test boon beyond 2021

CEO Stephen MacMillan told investors he expects hospitals to screen all patients coming in for procedures for at least the next couple of years. "We believe, and we've made the bet, that there is a longer tail." 

By Nick Paul Taylor • Nov. 5, 2020

FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy

The agency alert, prompted by reports from nursing homes and other settings, comes a day after data emerged raising concerns about the ability of a Quidel test to detect asymptomatic cases.

By Nick Paul Taylor • Nov. 4, 2020

Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study

The company has yet to apply for FDA emergency use authorization after a 159-participant study. Such tests may "hold immense power," said Harvard epidemiologist Michael Mina, also warning EUAs are "not exactly a high bar."  

By Greg Slabodkin • Nov. 2, 2020

Siemens Healthineers projects up to 8% revenue growth in FY2021

The German imaging and diagnostics giant said it won U.S. antitrust approval for its planned $16.4 billion buyout of radiation oncology specialist Varian in late October, helping the deal close in the first half of 2021.

By Maria Rachal • Nov. 2, 2020

Hologic wins $119M from HHS, DOD to help double COVID-19 test production

The medtech will make 13 million diagnostics a month in the U.S. by January 2022. Separately, InBios International scored $12.7 million to expand rapid point-of-care antigen and antibody test manufacturing.

By Nick Paul Taylor • Nov. 2, 2020

Quidel Q3 revenue soars 276% as COVID-19 tailwinds forecast into 2022

CEO Doug Bryant told investors the company is ramping up test production in anticipation of the convergence of flu season with the ongoing pandemic.

By Greg Slabodkin • Oct. 30, 2020