Diagnostics: Page 50
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CMS widens NGS test coverage for inherited breast, ovarian cancers
The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.
By Maria Rachal • Jan. 28, 2020 -
Natera takes ArcherDX to court over cancer testing patent
Genetic testing company Natera claims it has exclusive rights to use multiplex PCR in certain cancer settings.
By Nick Paul Taylor • Jan. 28, 2020 -
CDC urgently working to make coronavirus lab diagnostic available
A Centers for Disease Control and Prevention official told reporters the agency is in the process of growing the virus for further study and working to get laboratory diagnostics to state and local health departments.
By Shannon Muchmore • Jan. 27, 2020 -
3 more notified bodies coming soon, EC says as MDR clock ticks down
New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.
By Nick Paul Taylor • Jan. 23, 2020 -
Abbott ups 2020 growth targets, downplays Libre 2 delay
After exceeding the high end of its 2019 sales forecast on success in electrophysiology, heart failure, structural heart and diabetes, the company forecasts up to an 8% rise in organic growth this year.
By Maria Rachal • Jan. 22, 2020 -
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 -
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. 9, 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. 3, 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. 3, 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, 2019 -
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, 2019 -
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 -
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. 6, 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. 5, 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. 4, 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. 2, 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. 2, 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. 2, 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
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