Diagnostics
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ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
By Nick Paul Taylor • Jan. 15, 2020 -
LabCorp, Quest push for M&A-driven growth despite difficulties closing deals
“It’s still a very fragmented marketplace,” said Quest CEO Steve Rusckowski at JPM. "Trying to get people to move fast has been harder than I would have anticipated,” LabCorp's new CEO Adam Schechter told investors.
By Nick Paul Taylor • Jan. 15, 2020 -
Nevro, NuVasive, Integra, others preview earnings at JPM
Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.
By Maria Rachal • UPDATED: Jan. 15, 2020 at 9:20 a.m. -
Adaptive gets CMS coverage for chronic lymphocytic leukemia test
The expanded Medicare policy covers use of the assay in the monitoring of minimal residual disease.
By Nick Paul Taylor • Jan. 09, 2020 -
CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021
The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.
By David Lim • Jan. 03, 2020 -
Illumina scraps $1.2B PacBio takeover amid regulatory pushback
Cowen analysts listed Agilent, Danaher and Thermo Fisher as potential buyers of Pacific Biosciences.
By Nick Paul Taylor • Jan. 03, 2020 -
Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.
By Nick Paul Taylor • Dec. 31, 2020 -
Myriad wins FDA nod for Lynparza companion diagnostic
The test is meant to identify metastatic pancreatic cancer patients with a germline BRCA mutation who are candidates for AstraZeneca and Merck's pill, the second targeted treatment approved for pancreatic cancer.
By Jonathan Gardner • Dec. 30, 2020 -
FTC seeks to block Illumina's $1.2B PacBio acquisition over monopoly concerns
Illumina announced Wednesday it will extend the end time of its merger plan with PacBio to March 31, 2020.
By David Lim • UPDATED: Dec. 19, 2019 at 9:24 a.m. -
FDA greenlights first newborn screening test aid for Duchenne muscular dystrophy
Labs now have the option to add the PerkinElmer kit to newborn screening panels, coinciding with a controversial FDA turnaround in approving a new treatment for the rare genetic disorder.
By Maria Rachal • Dec. 12, 2019 -
EC medical device group sheds new light on MDR, IVDR sampling codes
The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.
By Nick Paul Taylor • Dec. 12, 2019 -
BioMarin taps Invitae to expand genetic testing for skeletal dysplasia
As it develops drug treatment for a form of skeletal dysplasia, BioMarin is bankrolling a program in which medical genetic testing company Invitae will screen for 109 genes linked to rare bone and joint disorders.
By Nick Paul Taylor • Dec. 11, 2019 -
Roche MRSA test wins FDA De Novo OK
The agency said the novel diagnostic technology can deliver results in as few as five hours, versus the one to two day wait with conventional methods.
By Nick Paul Taylor • Dec. 06, 2019 -
Philips to offer Paige.AI's prostate cancer detection tech
Weeks after Memorial Sloan Kettering Cancer Center spinout Paige.AI won a CE mark for its diagnostic tools, Philips announced it will combine its own digital pathology capabilities with the startup's prostate cancer product.
By Dana Elfin • Dec. 05, 2019 -
FDA grants breakthrough status to eye-tracking Parkinson's test
The diagnostic test is designed to detect persistent ocular tremors, a symptom research suggests appears early and is pervasive in Parkinson's patients.
By Nick Paul Taylor • Dec. 04, 2019 -
MRI screening linked to improved detection of breast cancer
The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.
By Nick Paul Taylor • Dec. 02, 2019 -
Feds charge lab owner in latest genetic testing kickback scheme
The charges come just two months after the Department of Justice shone the light on an alleged scam involving 35 people and multiple genetic testing and telemedicine companies costing Medicare $2.1 billion.
By Susan Kelly • Dec. 02, 2019 -
FDA approves TB test from Qiagen and DiaSorin
The approval could be a win-win for both companies, bringing Qiagen's TB blood test to DiaSorin's Liaison immunoassay analyzers while expanding the testing menu for Liaison.
By Nick Paul Taylor • Dec. 02, 2019 -
Boston Heart to pay $26.7M to settle alleged doctor kickback scheme
Allegations against the clinical diagnostics company included that it made payments to doctors disguised as investment returns in exchange for referrals.
By Susan Kelly • Nov. 27, 2019 -
Roche facing $137M in damages over diagnostic patent dispute after jury verdict
The ruling relates to technology used in Roche's cobas line of immunoassay analyzers.
By Nick Paul Taylor • Nov. 27, 2019 -
Carolina Liquid gets FDA warning over sale of unauthorized reagents
FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval.
By Nick Paul Taylor • Nov. 20, 2019 -
Qiagen in talks with potential buyers amid weak results, restructuring
The molecular test maker confirmed Friday it has received several non-binding indications of interest, days after Bloomberg reported Thermo Fisher was eyeing a takeout of Qiagen.
By Susan Kelly • Nov. 18, 2019 -
BARDA backs Inflammatix test to improve antibiotic use
The $6 million contract will fund efforts to distinguish between bacterial and viral infections in a bid to limit overprescribing of antibiotics and the emergence of superbugs.
By Nick Paul Taylor • Nov. 15, 2019 -
Paige gets CE mark for prostate cancer detection technology
The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.
By Nick Paul Taylor • Nov. 13, 2019 -
FDA grants breakthrough status to AI-based gastric cancer diagnostic
The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.
By Nick Paul Taylor • Nov. 12, 2019
