Diagnostics: Page 40
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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 -
Roche COVID-19, flu combo test gets FDA emergency authorization
It is the fourth EUA for a diagnostic that detects and differentiates the viruses. However, the company claims to be the first commercial test that runs on fully automated high-throughput systems using a single sample.
By Greg Slabodkin • Sept. 4, 2020 -
NIH awards $129M to scale up US COVID-19 testing capacity
Illumina, Sonic Healthcare and PathGroup are among recipients of the funds with a goal to handle 454,000 tests a day. However, the country needs millions more daily tests above current levels.
By Nick Paul Taylor • Sept. 3, 2020 -
Final inpatient payment rule confirms price transparency push
The American Hospital Association quickly criticized the CMS decision to move forward with collecting data on hospital median payer-specific negotiated charges to guide relative Medicare payment rates.
By Hailey Mensik • Updated Sept. 3, 2020 -
Courtesy of Quest Diagnostics
Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results
Gov. Ron DeSantis ordered all Florida agencies to sever testing relationships with the lab giant, which apologized for the delay in getting data to state health authorities in the timely manner required by law.
By Susan Kelly • Sept. 2, 2020 -
Roche set to launch rival to Abbott's rapid COVID-19 antigen test
The diagnostics giant expects to make 40 million of the instrument-free tests a month when it launches in late September and more than double that by the end of 2020, but doesn't yet have emergency authorization from FDA.
By Nick Paul Taylor • Sept. 2, 2020 -
UK outlines post-Brexit medical device regime starting January
Regulators unveiled a future U.K. Conformity Assessed (UKCA) mark, but will continue recognizing CE marks until mid-2023 and give companies four to 12 months to register their devices and in vitro diagnostics.
By Nick Paul Taylor • Sept. 2, 2020 -
HHS backs COVID-19 antigen testing for nursing homes, preempting regional restrictions
Although some state and local authorities are concerned about the accuracy of such rapid diagnostics, sold by Abbott, BD and others, the move comes amid rising calls for their use to test large numbers of people.
By Nick Paul Taylor • Sept. 1, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Comparisons of COVID-19 saliva, swab tests paint mixed picture
Study findings published the same day in the New England Journal of Medicine and Annals of Internal Medicine have conflicting messages on saliva tests, which FDA has greenlit from developers including Fluidigm and Phosphorus.
By Nick Paul Taylor • Aug. 31, 2020 -
"White House Press Briefing". Retrieved from The White House.
Abbott gets $760M contract from HHS to deliver 150M antigen tests
The deal comes just one day after the company's antigen test received FDA emergency use authorization. BD, Quidel and LumiraDx previously got the agency's nod for their diagnostics.
By Greg Slabodkin • Aug. 28, 2020 -
Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up
The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.
By Greg Slabodkin • Aug. 27, 2020 -
Abbott gets EUA for rapid $5 COVID-19 antigen test
As the fourth company to get the FDA emergency nod, the medtech giant's scale makes it a "significant entry [that] could help democratize testing," said former agency head Scott Gottlieb.
By Nick Paul Taylor • Aug. 27, 2020
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