Diagnostics: Page 56
-
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
EU device group clarifies incoming database requirements
The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.
By Nick Paul Taylor • April 16, 2019 -
J&J wins FDA OK for first targeted therapy in bladder cancer
The agency also approved a companion diagnostic from Qiagen designed to test alterations in FGFR, which are targeted by first-of-its-kind drug Balversa.
By Ned Pagliarulo • April 12, 2019 -
LabCorp partners with Qiagen to speed launch of companion diagnostics
The collaboration leverages Qiagen's lab program for newly approved cancer drugs and targeted IVDs.
By Meg Bryant • April 5, 2019 -
FDA serves warning letter to Virginia lab over pharmacogenetic claims
The reprimand to Inova Genomics Laboratory comes as Congress considers granting the agency more authority to regulate laboratory developed tests.
By David Lim • April 5, 2019 -
CMS to tackle lab payments codes in pair of public meetings
The agency will meet on June 24 to hear comments on setting payment amounts for codes being considered under the Clinical Laboratory Fee Schedule for 2020.
By Susan Kelly • April 1, 2019 -
FDA finalizes rules for anthrax bacteria tests, spine devices
Both devices have been classified as Class II, with special controls, and will continue to require a 510(k) premarket notification.
By Susan Kelly • April 1, 2019 -
FDA seeks to step up mammography oversight, info sharing
A new rule would standardize how facilities are required to inform patients of their breast tissue density, which can impact imaging efficacy and overall breast cancer risk.
By Maria Rachal • March 28, 2019 -
Grassley slams Verma over lab overpayment answers
CMS Administrator Seema Verma acknowledged the agency relied on maximum payment rates as a baseline for the clinical laboratory fee schedule rather than average rates.
By David Lim • March 27, 2019 -
CMS set to reopen controversial cancer test policy
The potential reassessment follows accusations of "significant policy overreach" by CMS amid concerns the policy could stop early-stage cancer patients from accessing next generation sequencing tests.
By Nick Paul Taylor • March 27, 2019 -
LifeScan dominates Medicare diabetes test strip market, OIG finds
The analysis found LifeScan's OneTouch Ultra held 29% of the non-mail order market, more than twice as much as its nearest rival.
By Nick Paul Taylor • March 26, 2019 -
Biomagnetic imaging for chest pain wins FDA clearance
The rapid, noninvasive imaging test from Genetesis, a Mason, Ohio-based startup, measures the magnetic fields produced by the heart’s electrical activity.
By Susan Kelly • March 25, 2019 -
Not even money prods patients to mail-in colon tests, study suggests
The fecal immunochemical test is used to find small amounts of blood in the stool that could be a sign of cancer or polyps.
By Susan Kelly • March 25, 2019
Previous
