Diagnostics: Page 2

Trump admin sitting on $14B for testing, tracing, Democratic senators say

A letter urging the administration to ramp up its COVID-19 spending comes a day after President Donald Trump told a rally he had directed officials to slow down testing to keep case numbers low.

By Rebecca Pifer • June 22, 2020

Invitae scoops up ArcherDX in $1.4B precision oncology deal

The acquisition comes shortly after ArcherDX made moves to go public and valued its market opportunity at $45 billion. Invitae's stock is up nearly 40% on the news.

By Maria Rachal • June 22, 2020

Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says

The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.

By Maria Rachal • June 19, 2020

FDA cracks down on sellers of at-home COVID-19 antibody tests

A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.

By Nick Paul Taylor • June 18, 2020

TÜV SÜD becomes 4th notified body designated under IVDR

It's the first notified body OK'd by the European Commission in 2020 to increase capacity for the forthcoming In Vitro Diagnostic Regulation, set to come into force in less than two years.

By Nick Paul Taylor • June 18, 2020

FDA revokes emergency authorization for Chembio's COVID-19 antibody test

It's the first time the agency has exercised such authority for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.

By Greg Slabodkin • June 17, 2020

NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus

The agency did not disclose which antibody test it will use as part of the All of Us initiative, saying only that the assay has FDA emergency use authorization and is designed to detect IgG antibodies. 

By Nick Paul Taylor • June 17, 2020

Myriad prostate cancer test wins coverage from Aetna

The decisions by the insurance giant and two others nearly double commercial coverage for the Prolaris test, days after a local Medicare contractor found there may be insufficient data to back Myriad's GeneSight combinatorial tests.

By Susan Kelly • June 16, 2020

Labs urge CDC to change COVID-19 antibody test guidelines

The trade group for Quest Diagnostics and LabCorp criticized the federal agency's advice against use of serology test results to make decisions about who can return to work.

By Nick Paul Taylor • June 16, 2020

COVID-19 diagnostic testing costs may hit $25B per year, AHIP study finds

And on the antibody testing front, costs could range between $5.2 billion and $19.1 billion, according to a report commissioned by the payer trade group.

By Shannon Muchmore • June 11, 2020

Cue Health raises $100M to scale up rapid, portable coronavirus test

The startup, which counts J&J among its backers, said on Friday it received FDA emergency use authorization for its test, allowing use anywhere under the supervision of qualified medical personnel. 

By Nick Paul Taylor • UPDATED: June 12, 2020 at 11:37 a.m.

MedTech Europe pitches virtual audits to clear MDR coronavirus logjam

The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.

By Nick Paul Taylor • June 11, 2020

Cepheid developing test to distinguish COVID-19 from flu

The company, which plans to pursue the FDA's emergency use authorization pathway for the four-in-one combination test, is aiming to have it ready for next flu season, when a potential spike in coronavirus cases could occur.

By Susan Kelly • June 10, 2020

DOJ charges medtech exec with $69M in COVID-19 test fraud, notes Theranos parallel

The Department of Justice said the case against an Arrayit Corporation exec is the first criminal securities fraud prosecution in relation to the pandemic.

By Nick Paul Taylor • June 10, 2020

Ex-FDA chief scientist slams 'chaos' caused by agency approach to antibody tests

Jesse Goodman said the agency’s decision to allow developers of COVID-19 serology tests to self-validate their products led unqualified entities to flood the market.

By Nick Paul Taylor • June 10, 2020

Siemens Healthineers, Geisinger ink 10-year digital health partnership

It's one of the medtech's largest partnerships of its kind in North America, as it plans to provide diagnostic imaging and artificial intelligence-enabled applications to the health system over the next decade.

By Greg Slabodkin • June 09, 2020

FDA expands at-home, saliva-based coronavirus testing with nod to Phosphorus

Individuals can obtain a test kit from the genomics startup without using an outside telemedicine platform.

By Nick Paul Taylor • June 09, 2020

Lawmakers push HHS to funnel funds to clinical labs amid routine testing decline

Members of Congress on both sides of the aisle argue the investments laboratories are making to scale up COVID-19 testing mean they need more targeted financial support, which should come out of a $25 billion relief fund.

By Nick Paul Taylor • June 09, 2020

COVID-19 false negatives fuel call for urgent focus on asymptomatic patients

Harvard and Yale physicians writing in the New England Journal of Medicine called for development of a reference standard for measuring sensitivity of coronavirus tests in those without symptoms who may infect others.

By Nick Paul Taylor • June 08, 2020

Healthcare sector adds 312K jobs in May, but hospitals left out

A collective uptick of roughly 124,000 jobs in health professional and physician offices suggests patients who have been delaying non-urgent medical care are back and seeking treatment outside hospitals. 

By Hailey Mensik • UPDATED: June 8, 2020 at 10:23 a.m.

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 05, 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 04, 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 04, 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 04, 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 03, 2020