Diagnostics: Page 32
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Abbott
Abbott, Quest look to post-pandemic home testing beyond COVID-19
With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.
By Greg Slabodkin • April 27, 2021 -
GE Healthcare grows sales as routine screening, elective procedures return
The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.
By Nick Paul Taylor • April 27, 2021 -
Permission granted by Quidel Corporation
Quidel shakes Wall Street with bearish COVID-19 test forecast
The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.
By Greg Slabodkin • April 23, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Science groups urge caution against using certain COVID-19 test data
The Association for Molecular Pathology and the Infectious Diseases Society of America say relying on cycle threshold (Ct) values runs the risk of being misinterpreted due to a lack of standardization across test methods.
By Susan Kelly • April 23, 2021 -
Courtesy of Quest Diagnostics
Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes
CEO Steve Rusckowski told investors Thursday the lab giant's routine business continued its recovery to near pre-pandemic levels, helping offset coronavirus diagnostics coming in below estimates.
By Greg Slabodkin • April 22, 2021 -
Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty
The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.
April 22, 2021 -
Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics
Roche Diagnostics CEO Thomas Schinecker predicted second-quarter coronavirus sales would also be healthy, continuing into the third quarter.
By Greg Slabodkin • April 21, 2021 -
Courtesy of Abbott
Abbott misses Wall Street as COVID-19 test sales softer than expected
CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now."
By Greg Slabodkin • April 20, 2021 -
Photography by Gage Skidmore / Photo Illustration by Kendall Davis/MedTech Dive
FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan
The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.
By Nick Paul Taylor • April 16, 2021 -
Thermo Fisher to buy research contractor PPD for $17.4B
The deal comes months after a failed attempt by the company to acquire molecular diagnostics company Qiagen.
By Kristin Jensen • April 15, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
6 medtechs to watch when earnings kick off next week
First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines.
By Nick Paul Taylor • April 15, 2021 -
Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll
The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.
By Nick Paul Taylor • April 14, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lucira gets FDA nod for OTC molecular COVID-19 test
The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.
By Nick Paul Taylor • April 13, 2021 -
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions.
By Greg Slabodkin • April 12, 2021 -
Italy's DiaSorin buys Luminex in $1.8B deal for multiplex molecular testing assets
The takeover comes weeks after Roche agreed to pay $1.8 billion to buy GenMark Diagnostics for its multiplex testing capabilities. The two targets compete with BioFire and Quidel.
By Nick Paul Taylor • April 12, 2021 -
Hologic pens $795M Mobidiag buyout to expand in acute care testing
Wall Street analysts cheered the move, with Evercore ISI writing "it fills a major hole in the company's armament." The deal marks Hologic's fourth pick-up of 2021, including the $230 million takeover of Biotheranostics in January.
By Nick Paul Taylor • April 9, 2021 -
LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price
The COVID-19 test maker hopes to generate enough capital to pursue a point-of-care testing opportunity it values at $76 billion. It has a ways to go to deliver.
By Nick Paul Taylor • April 8, 2021 -
Permission granted by IQVIA
FDA-medtech consortium offers strategy to boost patient engagement in clinical trials
The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design.
By Nick Paul Taylor • April 7, 2021 -
Fewer heart tests ordered for telehealth patients in pandemic
Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.
By Susan Kelly • April 6, 2021 -
Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing
The medical genetics company expects Genosity's capabilities to increase access to its cancer test and reduce turnaround time, while a sizable investment led by SoftBank will support growth initiatives.
By Nick Paul Taylor • April 6, 2021 -
UCLA engineer calls for mitigation of biases of medical devices
The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.
By Nick Paul Taylor • April 5, 2021 -
Liquid biopsies dominate FDA's latest breakthrough device nods
Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.
By Nick Paul Taylor • April 5, 2021 -
Abbott, BD, Quidel tests get EUAs for asymptomatic COVID-19 serial screening
While the Abbott and Quidel authorizations are for over-the-counter use, BD's test requires a prescription, which "along with the fact an instrument is needed, limits the use-cases for the company significantly," William Blair analysts wrote.
By Greg Slabodkin • April 1, 2021 -
Courtesy of Quest Diagnostics
Quest sells minority share of Q2 Solutions for $760M
IQVIA, which previously owned 60% of Q2 Solutions, will now become the sole owner of the clinical trials laboratory company. Quest and IQVIA established Q2 Solutions as a joint venture in 2015.
By Ricky Zipp • April 1, 2021 -
Adeline Kon/MedTech Dive
A year into the pandemic, advanced cancer diagnoses are rising
Research from radiation oncologists and molecular pathologists add to evidence showing that many people skipped getting cancer screenings in 2020 as they avoided going to the doctor to minimize the risk of COVID-19 infection.
By Susan Kelly • March 31, 2021
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