Diagnostics: Page 2
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Lab group urges lawmakers to rescind FDA final rule on LDTs
A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.
By Nick Paul Taylor • Sept. 9, 2024 -
Samuel Corum via Getty Images
Illumina court ruling limits EU regulators’ merger review power
The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.
By Justin Bachman • Sept. 9, 2024 -
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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 -
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Diagnostic errors are common. Here are 4 ways to prevent them.
A new, more holistic approach to testing is needed to avoid mistakes that can cause harm, said Marcus Schabacker, CEO of the patient safety group ECRI.
By Susan Kelly • Updated Sept. 11, 2024 -
Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
By Susan Kelly • Sept. 3, 2024 -
andresr via Getty Images
Pathology group sues to block FDA lab test rule
The Association for Molecular Pathology is the second lab trade group urging the courts to void an FDA policy expanding oversight of diagnostic tests.
By Susan Kelly • Aug. 30, 2024 -
Courtesy of Qiagen
Qiagen, AstraZeneca expand companion diagnostic pact beyond cancer
The goal is to enable specialty care providers to perform genotyping while patients are undergoing routine clinical examination.
By Nick Paul Taylor • Aug. 29, 2024 -
Courtesy of Illumina
Illumina wins FDA approval for companion diagnostic cancer test
Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo, which target cancers that have specific genetic features.
By Nick Paul Taylor • Aug. 28, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on predetermined change control plans
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
By Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Roche
Roche to increase global laboratory capacity for mpox testing
The World Health Organization has declared an mpox outbreak to be a public health emergency of international concern.
By Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Quest Diagnostics
Quest inks deal for University Hospitals’ outreach lab services
The deal continues Quest’s expansion in Ohio and extends a string of acquisitions that began in May.
By Nick Paul Taylor • Aug. 23, 2024 -
Courtesy of NowDiagnostics
FDA OKs first at-home syphilis test
NowDiagnostics’ over-the-counter test can return results in 15 minutes with a single drop of blood.
By Ricky Zipp • Aug. 19, 2024 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Routine lab tests fail to detect long COVID in 10,000-person study
Even people with highly symptomatic long COVID may have “no clinically observable objective findings on routine laboratory testing,” according to a study published by the Annals of Internal Medicine.
By Nick Paul Taylor • Aug. 16, 2024 -
Courtesy of Grail
Grail to shed 350 workers in restructuring
Less than two months after splitting from Illumina, the liquid biopsy maker is refocusing resources as it pursues an FDA submission for the Galleri multi-cancer early detection test.
By Susan Kelly • Aug. 14, 2024 -
Permission granted by C2N Diagnostics
Unilabs inks deal to sell C2N Alzheimer’s blood tests in Europe
C2N Diagnostics announced the partnership after recently receiving an investment from the Japanese drugmaker Eisai, which developed the Alzheimer’s drug Leqembi with Biogen.
By Nick Paul Taylor • Aug. 12, 2024 -
The image by Coolcaesar is licensed under CC BY-SA 4.0
Cepheid to cut more than 600 employees in California
A spokesperson said the diagnostics firm is consolidating its U.S.-based cartridge manufacturing activities in California.
By Ricky Zipp • Aug. 8, 2024 -
Courtesy of Labcorp
Labcorp wins FDA OK for pan-solid tumor liquid biopsy
Shakti Ramkissoon, Labcorp’s medical lead for oncology, said the test could allow laboratories and oncologists to profile solid tumors when tissue samples are limited or unavailable.
By Nick Paul Taylor • Aug. 6, 2024 -
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
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