Diagnostics: Page 17
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Courtesy of Labcorp
Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue
To help reboot earnings, a planned spinoff of the Clinical Development business has been accelerated and the company will continue to acquire testing facilities from hospital systems across the country.
By Peter Green • Oct. 27, 2022 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher raises full-year revenue forecast after posting extra $200M in COVID-19 test sales in Q3
With COVID test sales expected to fall to an “endemic run rate level” in the fourth quarter, the company expects growth to come from the pharma services and bioproduction units.
By Nick Paul Taylor • Oct. 27, 2022 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
GE HealthCare revenue rose 6% in Q3 as supply chain woes ease
The medtech company says global healthcare spending is solid, particularly in Europe and Asia.
By Elise Reuter • Oct. 25, 2022 -
Sarah Silbiger via Getty Images
Accelerate Diagnostics withdraws BD-partnered device after FDA demands 510(k) clearance
An analyst said they were “somewhat surprised” by the FDA’s decision as “Arc does not directly lead to a patient result.”
By Nick Paul Taylor • Oct. 25, 2022 -
Retrieved from Analytical Chemistry on October 21, 2022
Algorithm cuts disease biomarker analysis from hours to minutes in ‘leap forward’ for diagnosis
The new process could accelerate diagnosis, replacing existing tests that take hours or require multistep processes run on specialized equipment.
By Nick Paul Taylor • Oct. 21, 2022 -
adamkaz via Getty Images
FDA moves to make effect on health equity part of breakthrough device considerations
If it finalizes the proposal, the agency will expand its breakthrough program to devices that improve accessibility.
By Nick Paul Taylor • Oct. 21, 2022 -
Courtesy of Quest Diagnostics
Quest Diagnostics raises 2022 revenue forecast even as Q3 sales slump; shares climb
The diagnostics firm says a shift in emphasis away from COVID-19 testing is paying off.
By Peter Green • Oct. 20, 2022 -
Brendan Hoffman via Getty Images
Testing overhaul faces a ‘narrow pathway’ to pass before year end, industry groups say
Despite bipartisan support, a bill to allow the FDA to regulate lab-developed tests still faces hurdles to inclusion in an omnibus spending package.
By Elise Reuter • Oct. 20, 2022 -
Courtesy of Abbott
Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations
The company raised its earnings forecast for 2022 on the back of an expected $7.8 billion in annual sales related to COVID-19 testing.
By Elise Reuter • Oct. 19, 2022 -
Courtesy of Magnolia
BD forms co-promotion pact with Magnolia to reduce blood culture contamination
Magnolia’s blood collection device diverts the first 1.5 to 2 milliliters of blood samples that may be contaminated with flecks of skin, paving the way for more accurate diagnosis of sepsis.
By Nick Paul Taylor • Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.
By Nick Paul Taylor • Oct. 19, 2022 -
Joe Raedle / Staff via Getty Images
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
COVID-19 test manufacturers have amended their fact sheets to state that diagnostics cleared or approved by the agency should be used instead of their emergency-authorized kits.
By Nick Paul Taylor • Oct. 17, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Results from the three companies are expected to shed light on how the economic slowdown is affecting procedure trends in the industry.
By Nick Paul Taylor • Oct. 17, 2022 -
Permission granted by Becton Dickinson
Q&AFriday Q&A: BD’s Broache talks women’s health, at-home testing
Test adoption has increased as more customers have installed BD’s testing machines and the company hopes to offer more at-home assays in the U.S.
By Elise Reuter • Oct. 14, 2022 -
Vladimir Vladimirov/Getty Images via Getty Images
GE shores up contrast supply through deal with Chilean miner
A multiyear agreement with a Chilean mining company and the addition of a manufacturing line in Ireland will help GE insure against supply-chain disruptions.
By Elise Reuter • Oct. 13, 2022 -
GE advances healthcare spinoff plan, providing close look at workings of the unit
Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.
By Nick Paul Taylor • Oct. 13, 2022 -
Retrieved from Jiangsu Well Biotech Co. on October 12, 2022
Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says
The company is the latest firm to recall rapid antigen tests that had never received an emergency use authorization or clearance from the regulator.
By Elise Reuter • Oct. 12, 2022 -
Courtesy of Qiagen
Bio-Rad, Qiagen are in talks over $10B merger, WSJ reports
While the two companies have been in talks for some time, the deal may fall through, the report said, citing people familiar with the matter.
By Ricky Zipp • Updated Oct. 11, 2022 -
Courtesy of Abbot Molecular
Abbott lands FDA emergency authorization for first commercial monkeypox test
Abbott’s testing process is fully automated to increase throughput to help control the spread of monkeypox.
By Nick Paul Taylor • Oct. 10, 2022 -
Courtesy of Paige
Q&AFriday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game
Commercial laboratories and academic medical centers are starting to adopt digital tools to help pathologists detect cancer, opening a large market for AI-powered diagnostic tools.
By Elise Reuter • Updated Oct. 8, 2022 -
Courtesy of Summa Health
Quest agrees to buy Ohio-based health system’s lab-testing business
It’s the latest deal in a string of acquisitions by commercial laboratory companies as hospitals seek to cut costs and improve testing capacity.
By Elise Reuter • Oct. 6, 2022 -
iStock via Getty Images
Roche wins FDA approval for companion diagnostic to support breast cancer therapy
The approval positions Roche to support the rollout of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-low breast cancer.
By Nick Paul Taylor • Oct. 5, 2022 -
Stock via Getty Images
Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system
The researchers called the system a “promising prototype,” while cautioning that further validation is needed.
By Nick Paul Taylor • Oct. 5, 2022 -
Permission granted by Roche
Roche Diagnostics taps new CEO
Matt Sause, the head of Roche Diagnostics’ North America region, is being promoted to lead the business.
By Elise Reuter • Oct. 4, 2022 -
Courtesy of Grail
Illumina looks to resolve Grail acquisition ‘sooner rather than later’: analysts
With a divestiture order from the European Commission looming, Illumina is looking at strategic options for the maker of blood tests used to detect cancer.
By Elise Reuter • Oct. 4, 2022
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