Diagnostics: Page 4
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Karen Ducey/Getty Images via Getty Images
Experts fear patient harm from FDA’s lab developed test rule
Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.
By Susan Kelly • Aug. 5, 2024 -
Courtesy of 23andMe
23andMe board rejects CEO Wojcicki’s take-private proposal
A special committee of the board said the proposal offers no premium to 23andMe’s stock price, and with a lack of committed financing, is “insufficient.”
By Elise Reuter • Aug. 2, 2024 -
Brad Barket via Getty Images
23andMe CEO proposes to take company private
Anne Wojcicki, who co-founded 23andMe, would pay 40 cents per share to buy the DNA testing company, which has been trading under $1 for nearly a year.
By Elise Reuter • Aug. 1, 2024 -
Courtesy of GE Healthcare
GE Healthcare faces pressure in China as hospitals delay orders
Johnson & Johnson’s medtech business and Philips also cited China’s order slowdown for sluggish revenue growth in the second quarter.
By Susan Kelly • Aug. 1, 2024 -
Justin Sullivan via Getty Images
Labcorp expands Ultima pact to boost genomic diagnostics
Labcorp will use Ultima Genomics’ UG 100, a machine designed to sequence the genome for $100, to assess molecular residual disease.
By Nick Paul Taylor • July 31, 2024 -
Courtesy of Guardant Health
Guardant wins FDA approval for colon cancer blood test
Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.
By Susan Kelly • July 29, 2024 -
Spencer Platt via Getty Images
AI’s expert-level image analysis can be built on flawed rationales: study
Researchers at the National Institutes of Health found that a version of ChatGPT analyzed images at an expert level but frequently reached the right answer with incorrect reasoning.
By Nick Paul Taylor • July 25, 2024 -
Courtesy of Business Wire
Guardant settles allegations it violated the False Claims Act
The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.
By Nick Paul Taylor • July 23, 2024 -
Courtesy of Truvian
Truvian raises $74M to bring blood test instrument to market
The device is designed to perform the most commonly ordered blood tests, avoiding the need to send the samples to central labs.
By Nick Paul Taylor • July 22, 2024 -
Permission granted by Medtronic
Q&A‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
By Susan Kelly • July 22, 2024 -
deliormanli via Getty Images
Danaher setting up labs to support companion diagnostic development
Danaher plans to open a U.K. laboratory this month, followed by a second facility in the U.S. later this year.
By Nick Paul Taylor • July 18, 2024 -
Ryan David Brown/Getty Images via Getty Images
Deep DiveMedtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
By Jasmine Ye Han , Ricky Zipp , Elise Reuter • Updated July 25, 2024 -
Courtesy of Qiagen
Qiagen to cut 175 employees, close Michigan PCR test plant
The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.
By Elise Reuter • July 17, 2024 -
Courtesy of Quest Diagnostics
Quest closing Pennsylvania lab, laying off 121 people
Quest is consolidating drug testing at a facility in Kansas, but will keep rapid response, pathology and IT staff at the Norristown site.
By Nick Paul Taylor • July 17, 2024 -
Courtesy of Intuitive Surgical
J&J, Abbott and Intuitive start medtech earnings season
The companies’ financial results will offer a glimpse at the current health of medtech markets.
By Nick Paul Taylor • July 16, 2024 -
Jemal Countess via Getty Images
House committee tells FDA to suspend lab developed test rule
Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”
By Nick Paul Taylor • July 15, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
By Susan Kelly , Elise Reuter • July 11, 2024 -
Courtesy of BD
FDA warns BD blood culture bottle shortage could impact diagnosis
BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.
By Nick Paul Taylor • July 11, 2024 -
Courtesy of Quest Diagnostics
Quest to buy Lifelabs for $985M
Buying the Canadian laboratory company opens a new front in Quest’s rivalry with Labcorp and marks its third takeover in as many months.
By Nick Paul Taylor • July 8, 2024 -
Courtesy of Roche
Roche sues Foresight and Stanford, alleging use of trade secrets
Roche said Stanford applied for patents relating to cancer detection and monitoring technology using its confidential information.
By Nick Paul Taylor • July 3, 2024 -
Courtesy of U.S. Food and Drug Administration
Cepheid wins FDA nod for fingerstick hepatitis C test
Patients could be diagnosed and potentially receive treatment at the same healthcare visit.
By Nick Paul Taylor • June 28, 2024 -
David Ryder via Getty Images
FDA partners with Gates Foundation to support breath-based diagnostic development
Through a $1.9 million Gates Foundation grant, the collaborators will create methods to help developers make tests that can easily be deployed to rural and remote areas.
By Nick Paul Taylor • June 27, 2024 -
Courtesy of Grail
Illumina completes Grail spinoff
Nearly four years after Illumina announced a deal to buy Grail, the liquid biopsy maker will debut on Nasdaq Tuesday as a standalone company.
By Nick Paul Taylor • June 25, 2024 -
Retrieved from Dermtech on June 20, 2024
Dermtech files for Chapter 11, lays off 20% of staff
The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.
By Nick Paul Taylor • June 20, 2024 -
Permission granted by Agilent
Agilent to cut 3% of employees as sluggish lab equipment market persists
An Agilent spokesperson said the layoffs follow job cuts announced late last year amid a slower-than-expected market recovery.
By Susan Kelly • June 14, 2024
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