FDA warns of cyanide gas risk with certain media if used with Hologic coronavirus test

The agency alerted clinical labs and healthcare providers to the potential for bleach to react with guanidine materials and produce deadly gas, making it unsafe to use some transport media with Hologic’s assays.

By Nick Paul Taylor • June 5, 2020

Months into pandemic, Trump admin mandates labs report demographic data of COVID-19 tests

HHS is now requiring labs to submit a much broader range of data related to testing. However, the American Clinical Laboratory Association said it's difficult for labs to get information to public health agencies without help from providers.

By Rebecca Pifer • June 4, 2020

European Commission lays out timeline for next steps toward MDR, IVDR

Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.

By Nick Paul Taylor • June 4, 2020

PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report

FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.

By Maria Rachal • June 4, 2020

Governors plead for Trump admin to streamline swab, reagent distribution

"We're competing against other states and sometimes our own federal government," Colorado Gov. Jared Polis, a Democrat, told a House subcommittee Tuesday of challenges procuring COVID-19 testing supplies.

By Rebecca Pifer • June 3, 2020

US needs 10-fold increase in COVID-19 testing, analysts say

Jefferies' analysis predicts such an uptick could give test suppliers including Abbott, Hologic and Thermo Fisher a collective $16 billion boost, while LabCorp and Quest Diagnostics may share in a $50 billion tailwind.

By Nick Paul Taylor • June 2, 2020

Tests to detect cancer, guide treatment heat up with barrage of data at ASCO

Exact Sciences, Guardant Health and Oncocyte were among the companies to share data on products targeting breast and lung cancers.

By Nick Paul Taylor • June 1, 2020

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

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

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