Diagnostics: Page 39
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Roche diagnostics Q3 sales spiked 18% as COVID-19 offset routine test drop
Execs contend the momentum is sustainable even with arrival of a vaccine, citing government demand for high-throughput machinery and a shift in importance to antibody testing.
By Maria Rachal • Oct. 15, 2020 -
Courtesy of Qiagen
Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics
Non-coronavirus revenue saw a mid-single-digit drop and sales of a key TB test fell 20%. While those metrics improved from earlier in the year, Cowen analysts said the slump gives ammunition to doubters.
By Nick Paul Taylor • Oct. 14, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
J&J-backed Cue gets $481M to onshore production of rapid COVID-19 test kit
The startup will use the government funding to scale production to 100,000 COVID-19 test kits a day at its San Diego facilities.
By Nick Paul Taylor • Oct. 14, 2020 -
Cancer testing drives 2020 medtech IPO surge after slow start
A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.
By Nick Paul Taylor • Oct. 12, 2020 -
Courtesy of AdvaMed
5 key exec insights from 2020's MedTech Conference
Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.
By Maria Rachal • Oct. 9, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify
Shortages of test kits and other supplies persist, according to the labs polled by the Association for Molecular Pathology.
By Nick Paul Taylor • Oct. 9, 2020 -
FDA takes hands off EUA review for COVID-19 lab developed tests
The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."
By Greg Slabodkin • Oct. 8, 2020 -
Courtesy of Abbott
Abbott, on defense, details embattled rapid COVID-19 test results
New data on the ID Now product comes amid criticism that the White House leaned too heavily on the quick-turnaround diagnostic, in light of President Donald Trump's illness and widespread West Wing infection.
By Nick Paul Taylor • Oct. 7, 2020 -
'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says
Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.
By Greg Slabodkin • Oct. 7, 2020 -
M&A on horizon as deep-pocketed medtechs eye distressed assets: EY
The combination of smaller companies questioning their pandemic survival and larger companies with considerable capital may spark a buying surge, the consultancy said in its annual medtech report.
By Nick Paul Taylor • Oct. 6, 2020 -
Ex-FDA chief Gottlieb questions White House reliance on Abbott COVID-19 test amid Trump diagnosis
"The Cepheid GeneXpert probably would be more fit to purpose. But, frankly, you'd need double layers of testing," President Donald Trump's former agency head said in a television appearance Sunday.
By Greg Slabodkin • Oct. 5, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Quidel antigen test to detect COVID-19 and flu gets FDA nod
While Roche, Cepheid and LabCorp are among the companies offering combination tests, Quidel is the first to sell a fast-turnaround antigen-based option.
By Nick Paul Taylor • Oct. 5, 2020 -
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 -
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
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