Diagnostics

At-home COVID-19 test kits set to climb as Quest, LetsGetChecked get FDA nods

Direct-to-consumer startup LetsGetChecked currently has capacity for 300,000 of the self-collection products per week. Quest hasn't yet launched its offering but said more than 500,000 of its sampling kits will be available by end of June.

By Maria Rachal • May 29, 2020

Widespread shortages for COVID-19 test materials persist, poll says

The survey by the Association for Molecular Pathology also found Abbott and Roche make the first-choice assays in 16% and 17% of centers, respectively — the most popular after in-house diagnostics with EUAs.

By Nick Paul Taylor • May 29, 2020

Emergency authorization granted to COVID-19 ICU prediction software

The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.

By Nick Paul Taylor • May 28, 2020

FDA offers reference panel to validate coronavirus tests amid false negatives

The aim is to aid commercial and lab developers in ensuring diagnostic testing quality with independent performance validation. Recent studies flagged double-digit rates of false negatives among such tests.

By Nick Paul Taylor • May 28, 2020

FDA Breakthrough Devices Program nears 300 designations

The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.

By Susan Kelly • May 27, 2020

CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers

The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.

By Nick Paul Taylor • May 27, 2020

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests

The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.

By Nick Paul Taylor • May 22, 2020

Hospitals push FEMA to form broad supply pact with medtech

The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.

By Nick Paul Taylor • UPDATED: May 26, 2020 at 7:20 a.m.

Labs welcome CMS rate for coronavirus antibody testing

Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.

By Nick Paul Taylor • May 20, 2020

Coronavirus pushes Mayo Clinic's operating income into free fall

Operating income plunged 88% by the end of the first quarter due to the pandemic and the near closure of the health system's outpatient business. Still, Mayo has become a leader in COVID-19 testing. 

By Samantha Liss • May 19, 2020

Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing

The separate projects aim to incorporate machine learning algorithms to enhance technologies meant to support COVID-19 patients.

By Susan Kelly • May 19, 2020

FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests

The emergency use authorization to Everlywell follows earlier nods to LabCorp and Rutgers Clinical Genomics Laboratory for at-home specimen collection for analysis solely at their own labs.

By Nick Paul Taylor • May 18, 2020

Abbott on defense as FDA flags false negative reports with point-of-care coronavirus test

An independent study circulated this week showed the rapid ID Now COVID-19 test could miss 48% of positive cases under some conditions. Abbott said late Thursday a backup test should be performed in certain cases.

By Nick Paul Taylor • May 15, 2020

House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package

The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.

By Susan Kelly • UPDATED: May 18, 2020 at 10:38 a.m.

Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients

Developed with the Mayo Clinic, Eko's algorithm gained breakthrough device status in December and review was further accelerated given its potential to identify patients at higher risk of poor outcomes with the coronavirus.

By Nick Paul Taylor • May 13, 2020

As Trump pushes states to reopen, Fauci warns against lifting COVID-19 restrictions too soon

The U.S. doesn't have the necessary testing and surveillance infrastructure in place to prep for a fall resurgence of the coronavirus, a second wave that's "entirely conceivable and possible," Fauci told a Senate panel.

By Rebecca Pifer • May 12, 2020

LabCorp at-home collection test kit for coronavirus goes mainstream, as states get $11B for testing efforts

The tests, originally only offered to frontline workers, are now available even to individuals without symptoms who may have been exposed to the virus. Still, clinical labs say more support is needed to further ramp up capacity.

By Greg Slabodkin • May 12, 2020

Latest Abbott coronavirus antibody test receives FDA emergency use OK

The EUA is the company's second for a test detecting the IgG antibody, using a different machine than the first. Across both, it plans to ship almost 30 million units worldwide in May and double that amount in June. 

By Greg Slabodkin • May 11, 2020

1st antigen test to detect coronavirus gets FDA nod

The agency, which gave the green light on Saturday to Quidel, expects the tests to be cheaper to make than PCR tests.

By Nick Paul Taylor • May 11, 2020

Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses

Much of the sector may be considered recession-proof — but it's not social distancing-proof. The last weeks of March previewed the dramatic trajectory of drops in routine testing and a mounting backlog of elective procedures.

By Maria Rachal • May 07, 2020

10 stories on the state of COVID-19 testing in the US

Despite medtechs' efforts to rapidly scale production of diagnostic and antibody tests, and commercial labs' work to make them more widely available, the U.S. still lacks adequate testing capacity, even as localities mull easing lockdowns. 

BD says surgery revenues fell as much as 70% in April

As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.

By Greg Slabodkin • May 07, 2020

FDA details COVID-19 era reporting rules to stymie medical device shortages

Under new powers granted by the CARES Act for the duration of the health crisis, the guidance to industry lays out when and how to notify the agency about changes that could affect product availability.

By Nick Paul Taylor • May 07, 2020

Qiagen aims for 50-fold jump in coronavirus test reagent output

The company, in the midst of being acquired by Thermo Fisher, reached capacity in April to support 7 million real-time PCR tests to detect the virus, with a target of 20 million per month by year’s end.  

By Nick Paul Taylor • May 07, 2020

Fitbit launches its 1st large-scale, virtual AFib study

The atrial fibrillation detection effort follows work by wearables rival Apple targeting the stroke risk factor that affects 33.5 million people globally.

By Greg Slabodkin • May 06, 2020