Diagnostics: Page 40
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Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets
The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.
By Nick Paul Taylor • Oct. 2, 2020 -
Adeline Kon/MedTech Dive
Deep Dive5 ways COVID-19 is reshaping the medtech industry
Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.
By Maria Rachal , Greg Slabodkin • Oct. 1, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 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 -
COVID-19 spurred a medtech M&A boom this summer. Will it last?
Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear.
By Nick Paul Taylor • Sept. 30, 2020 -
Data, supply chain constraints still dog COVID-19 testing, NIH officials say
Former heads of BARDA and NESTcc highlighted a need for comparing test types and protocols as the U.S. seeks to boost point-of-care options for asymptomatic and pre-symptomatic people.
By Maria Rachal • Sept. 29, 2020 -
6.5M Abbott COVID-19 antigen tests to reach states this week
Initial distribution of the rapid point-of-care diagnostics is meant to help reopen economies and schools, President Donald Trump said. It's still far short of the 200 million some experts say are needed each month.
By Greg Slabodkin • Sept. 29, 2020 -
CMS lowers barriers for labs seeking COVID-19 test certification
Administrator Seema Verma said the new tools are designed to improve the "obscure process and outdated modes of payment" for labs to obtain CLIA certification to test for COVID-19 during the pandemic.
By Susan Kelly • Sept. 28, 2020 -
Hologic receives FDA emergency use for asymptomatic COVID-19 test
The nod for the test, which must be sent to a lab for results, comes as point-of-care tests that provide on-site results take off and are embraced by health officials and experts.
By Greg Slabodkin • Sept. 28, 2020 -
Courtesy of Exact Sciences
Exact Sciences wows investors with preliminary multi-cancer liquid biopsy data
Cowen analysts acknowledged "a lot of work still needs to be done" but are "very enthused by the early data" on the Cologuard maker's blood test, which helped shares close up 27% on Thursday.
By Nick Paul Taylor • Sept. 25, 2020 -
FDA grants EUA to first point-of-care COVID-19 antibody test
The lateral flow assay from Assure Tech achieved positive and negative percent agreements of 100% for IgG and IgM antibodies combined.
By Nick Paul Taylor • Sept. 24, 2020 -
Courtesy of https://corporate.walmart.com/photos/walmart-store-exterior-at-night
Quest, Walmart pilot drone delivery of COVID-19 tests
The same-day service currently being tested in Las Vegas will use drones to drop at-home collection testing kits on driveways, front sidewalks and backyards.
By Nick Paul Taylor • Sept. 23, 2020 -
ACLA pushes back ahead of MedPAC's 2021 report to Congress on lab fee rates
The trade group for LabCorp and Quest is wary that the Commission's rate recommendations due in June could end up being overly burdensome and not reflective of the market for all lab services.
By Greg Slabodkin • Sept. 22, 2020 -
Kendall Davis/MedTech Dive
Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook
The analysts would "like to see the number of procedures stabilize, if not improve" before reconsidering predictions for the medical devices industry.
By Ron Shinkman • Sept. 21, 2020 -
Illumina inks $8B Grail buyout for liquid biopsy market. Investors are not sold.
Shares in Illumina, which formed cancer detection startup Grail in 2016, fell as analysts questioned whether the cash-and-stock deal plays to its strengths.
By Nick Paul Taylor , Greg Slabodkin • Sept. 21, 2020 -
Courtesy of Qiagen
Qiagen completes takeover of PCR automation player NeuMoDx for $248M
The still-independent Dutch molecular diagnostics company said NeuMoDx devices process test results three times as fast as some rival systems.
By Nick Paul Taylor • Sept. 18, 2020 -
PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower
PerkinElmer’s coronavirus nucleic acid kit achieved the lowest limit of detection, indicating greater sensitivity or ability to accurately detect the virus, in an agency comparison of 58 tests.
By Nick Paul Taylor • Sept. 18, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Cellex, Gauss ally to develop fully at-home, app-enabled COVID-19 antigen test
The first company to receive an FDA nod for a coronavirus antibody test is pairing its 15-minute antigen test with a smartphone app to automate interpretation of results. There might be a higher likelihood of false negatives.
By Nick Paul Taylor • Sept. 17, 2020 -
Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher
But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.
By Nick Paul Taylor • Sept. 17, 2020 -
Roche gets FDA nod for faster combo coronavirus-flu test
The diagnostic, designed to detect and differentiate SARS-CoV-2 and influenzas A and B, gives results within 20 minutes, compared to a prior authorized version for a Roche system with an hours-long turnaround.
By Greg Slabodkin • Sept. 16, 2020 -
BD probes COVID-19 false positives with point-of-care systems
The medtech's antigen tests have spurred demand from the federal government and states, but may be turning up incorrect results in nursing homes, The Wall Street Journal reported and the company confirmed Tuesday morning.
By Maria Rachal • Sept. 15, 2020 -
After uneven start to 2020, Hologic becomes Wall Street darling
An update Friday from the medtech that organic year-over-year revenue growth may reach 60% this quarter impressed some analysts, many of whom see capitalization in the COVID-19 environment being sustainable.
By Maria Rachal • Sept. 14, 2020 -
Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020
The company forecasts significantly higher growth this year than it's posted in the past, despite suffering a slow first quarter due to early disruption from the pandemic.
By Nick Paul Taylor • Sept. 11, 2020 -
Courtesy of Quest Diagnostics
Quest raises 2020 revenue outlook to beat pre-coronavirus goal by 10%
Despite worries that summer coronavirus hotspots could reverse the recovery for routine testing, the lab network said base volumes grew faster than expected through August.
By Maria Rachal • Sept. 10, 2020 -
Courtesy of BD/PRNewswire
BD says its antigen test on par with Quidel's in head-to-head preprint study
The state of Maryland announced Thursday it bought 250,000 of the BD tests, which the company contends have shown equivalent performance to Quidel's despite a difference in earlier published sensitivity claims.
By Greg Slabodkin • Sept. 10, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
LabCorp, DiaSorin tests differentiate COVID-19, flu, RSV
The companies join test developers including Roche, Qiagen, BioFire Diagnostics and Novacyt in preparing combination tests to tackle the challenges of the upcoming influenza season.
By Susan Kelly • Sept. 9, 2020 -
Grail files for $100M IPO ahead of 2021 launch of multi-cancer liquid biopsy
The Illumina spinout contends its Galleri test could avert 39% of deaths from cancers that would otherwise kill within five years, but acknowledges the challenge of getting payer support for asymptomatic screening.
By Nick Paul Taylor • Sept. 9, 2020
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