Diagnostics
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FDA tracks uptick in masks, other protective gear in coronavirus update
Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”
By Nick Paul Taylor • Feb. 18, 2020 -
LabCorp weathers rising personnel costs to beat expectations in Q4
Quest Diagnostics said the trend is an emerging source of pressure, while LabCorp had a more tempered reaction.
By Nick Paul Taylor • Feb. 13, 2020 -
Exact Sciences beefs up sales force as it seeks big Cologuard growth in 2020
The cancer diagnostics company said fresh TV ads and physicians' increasing ability to place orders through an updated version of Epic will spur sales of its colorectal cancer test.
By Nick Paul Taylor • Feb. 12, 2020 -
Snapshot: How medtech earnings season is shaping up
Medtech giant Medtronic failed to meet revenue targets, whereas orthopaedic device makers outperformed Wall Street expectations.
By Maria Rachal • UPDATED: Feb. 21, 2020 at 11:30 a.m. -
Longtime Myriad CEO resigns amid another steep earnings miss, guidance cut
Sales in the prenatal and hereditary cancer divisions, plus the seemingly promising GeneSight line, all declined during the quarter.
By Nick Paul Taylor • Feb. 07, 2020 -
Qiagen, still independent, limps back from 2019
The Dutch maker of infectious disease instruments and consumables is seeking a rebound, with an early boost from coronavirus-driven demand. Cowen analysts noted the firm beat expectations but added: "The bar was quite low."
By Nick Paul Taylor • Feb. 05, 2020 -
Emergency use coronavirus tests shows glitches at state level, CDC says
CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.
By Maria Rachal • UPDATED: Feb. 13, 2020 at 11:20 a.m. -
Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe
The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.
By Nick Paul Taylor • Feb. 04, 2020 -
Medtech in limbo as Brexit arrives
Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”
By Nick Paul Taylor • Feb. 03, 2020 -
Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics
Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.
By Maria Rachal • UPDATED: Jan. 31, 2020 at 4 p.m. -
UK moves to mitigate impact of notified body withdrawals
Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.
By Nick Paul Taylor • Jan. 30, 2020 -
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 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.
