Diagnostics: Page 55
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FDA authorizes Zika test, mulls revoking emergency clearances
The agency granted the first non-emergency marketing authorization for a Zika virus diagnostic to InBios.
By Nick Paul Taylor • May 24, 2019 -
Faulty platelet counts trigger Class I recall of Beckman Coulter devices
FDA is aware of more than 2,000 U.S. laboratories that may be affected by the inaccurate platelet counting but, so far, the agency hasn't received any reports of serious adverse events.
By Nick Paul Taylor • May 24, 2019 -
Medical equipment hit by escalation of US-China trade war
Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.
By Nick Paul Taylor • May 15, 2019 -
Deep Dive
Will a big needle burst the NASH bubble?
With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market.
By Jacob Bell • May 14, 2019 -
Grail's multi-cancer blood test nabs breakthrough device status
The Bezos and Gates-backed cancer diagnostic developer said the FDA designation will expedite the early detection methylation technology it is testing. Exact Sciences, Guardant Health and others share goals in the space.
By Maria Rachal • Updated May 14, 2019 -
Same-day upper and lower endoscopies improve care, costs: JAMA
Johns Hopkins researchers used Medicare claims data to identify patterns suggesting overuse of different-day scheduling, especially when physician offices and freestanding ambulatory surgery centers did the scheduling.
By Susan Kelly • May 14, 2019 -
LabCorp to sell Qiagen companion diagnostic for bladder cancer
The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved therascreen fibroblast growth factor receptor kinase inhibitor Balversa.
By Susan Kelly • May 13, 2019 -
Eye scan to detect Alzheimer's biomarker gets breakthrough status
Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy as a non-invasive, low-cost tool.
By Susan Kelly • May 10, 2019 -
Myriad guidance disappoints investors as pricing pressures dampen expectations
The molecular diagnostic company expects full year EPS to fall well short of the previously forecast range and warned pricing pressures will affect performance in 2020.
By Nick Paul Taylor • May 9, 2019 -
FDA updates imaging rules in final guidance
The agency aims to align U.S. performance standards for X-ray imaging equipment with international policy, efforts supported by industry groups, and clarify aspects of U.S. requirements for fluoroscopic equipment.
By Susan Kelly • May 8, 2019 -
Verily's nanoparticle diagnostic program evolves into Verve partnership
Alphabet's life sciences research arm was initially interested in nanoparticle diagnostics but thinks the program has therapeutic potential.
By Nick Paul Taylor • May 8, 2019 -
ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end
Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year.
By David Lim • May 7, 2019 -
Test for circulating tumor DNA wins FDA breakthrough designation
Genetic testing company Natera is developing the product to detect and quantify post-surgery ctDNA in the blood of patients already diagnosed with some types of cancer.
By Susan Kelly • May 7, 2019 -
Test for gene fusions in tumors gains breakthrough status
The assay from Caris Life Sciences is intended to detect fibroblast growth factor receptor biomarkers, including gene fusions, in solid tumors.
By Susan Kelly • May 6, 2019 -
EU issues device, diagnostics database requirements
The documents detail what data manufacturers will need to include in the European Database on Medical Devices for devices and in vitro diagnostics under its new regulations.
By Susan Kelly • May 6, 2019 -
AI diagnostic tool for kidney disease earns breakthrough status
The technology uses electronic health record information and machine learning algorithms to assess blood-based biomarkers and identify patients at risk for kidney disease progression.
By Susan Kelly • May 3, 2019 -
Abbott gets WHO prequalification for point-of-care HIV test
The diagnostic can expand access to viral load testing in resource-limited settings and improve management of HIV, Abbott said.
By Nick Paul Taylor • May 3, 2019 -
CMS reopens coverage determination on next generation sequencing for cancer patients
Healthcare organizations argued the agency's original decision would prevent Medicare beneficiaries with early-stage cancer from accessing NGS tests.
By Susan Kelly • April 30, 2019 -
LabCorp weathers PAMA, Quest competition to beat expectations
Pricing pressure and competition for UnitedHealth work dragged on performance, but LabCorp still grew diagnostic sales organically.
By Nick Paul Taylor • April 30, 2019 -
Labs make their case against PAMA cuts to 3-judge panel
If the U.S. Court of Appeals for the District of Columbia rules in favor of the American Clinical Laboratory Association, ​Quest Diagnostics and LabCorp stand to gain on Wall Street.
By David Lim • April 25, 2019 -
FDA hits Abaxis with warning letter over changes to assay
The warning letter comes nine months after Zoetis paid $2 billion to acquire Abaxis and its portfolio of veterinary point-of-care diagnostics.
By Nick Paul Taylor • April 25, 2019 -
Study supports genetic testing for sudden cardiac arrest
The research, published in the Journal of Cardiology, found the tests to be useful regardless of whether patients showed previous clinical evidence of heart disease.
By Susan Kelly • April 23, 2019 -
Quest beats analyst Q1 expectations as UnitedHealth drives volume growth
Expanded network access triggered volume growth, but PAMA-related reimbursement pressures sent operating income down 9%.
By Nick Paul Taylor • April 23, 2019 -
Best Buy, Target jump into at-home device market
The partnership is an example of companies reaching customers through mass retailers, tightening the relationship between healthcare and retail.
By Daphne Howland • April 18, 2019 -
Abbott beats guidance in Q1, ramps up full-year earnings forecast
The medical device unit led the way once again with 5.5% growth, largely fueled by fast-rising demand for the company's FreeStyle Libre continuous glucose monitor.
By Nick Paul Taylor • April 17, 2019
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