Diagnostic errors compounded by EHRs No. 1 safety fear: ECRI

"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," the medical device watchdog's William Marcella said.

By Meg Bryant • March 12, 2019

NCI Director Ned Sharpless to be named FDA acting commissioner

Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.

By David Lim , Maria Rachal • Updated March 12, 2019

NCI Director Ned Sharpless to be FDA acting commissioner

Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.

By Maria Rachal • March 12, 2019

23andMe to gauge Type 2 diabetes risk

The genetic testing company sees a big market opportunity in the chronic disease and argues risk is currently underscreened.

By Maria Rachal • March 11, 2019

Roche wins first immunotherapy approval for triple-negative breast cancer

On Monday Roche announced its Ventana PD-L1 Assay was approved as the first companion diagnostic to identify triple-negative breast cancer patients for the Tecentriq-Abraxane combination. 

By Ned Pagliarulo • Updated March 11, 2019

AI tool for cancer diagnosis wins FDA breakthrough status

Startup Paige.AI, through a licensing agreement with Memorial Sloan Kettering Cancer Center, is developing a portfolio of artificial intelligence-based products for use in the diagnosis of a range of cancers, starting with prostate cancer.

By Susan Kelly • March 8, 2019

Oral arguments in ACLA v. Azar appeal set for April 23

In a brief, HHS argued the American Clinical Laboratory Association does not have standing to bring a lawsuit over implementation of the Protecting Access to Medicare Act.

By David Lim • March 7, 2019

FDA advisers weigh in on HPV screens

The non-voting advisory committee's recommendations aimed to broaden clinical study participation and predicate evaluation of new tests on relative performance against a clinical endpoint comparator.

By Maria Rachal • Updated March 19, 2019

Ascension hospital network taps Abbott diagnostics for lab work

The deal will put Abbott's Alinity diagnostic systems to work for an additional 2.4 million patients.

By Susan Kelly • March 6, 2019

Machine learning model aims to match pathologists in IDing lung cancer

In an early test, a recently developed neural network proved to be "statistically on par" with the expertise of three pathologists in classifying lung cancer slides.

By Nick Paul Taylor • March 5, 2019

Blood test identifies proteins to predict preterm birth

Researchers found that five circulating microparticle proteins in first trimester blood samples could help predict risk, including among first-time mothers.

By Susan Kelly • March 4, 2019

Liquid biopsy as effective as tissue biopsy in lung cancer, study finds

A clinical trial found Guardant Health's test detected advanced non-small cell lung cancer at a similar rate to traditional tissue-based biopsies.

By Emily Mullin • March 1, 2019

Gene test for antibiotic resistance gets FDA breakthrough nod

The World Health Organization has identified antibiotic resistance as one of the biggest threats to global health.

By Susan Kelly • March 1, 2019

Thermo Fisher lung cancer test wins expanded approval in Japan

Japan's regulatory agency approved the Oncomine DX Target test to include three additional biomarkers for non-small cell lung cancer.  

By Susan Kelly • Feb. 27, 2019

Feds team up to speed diagnostic testing access in emergencies

Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.  

By David Lim • Feb. 27, 2019

Myriad plans companion diagnostic filing as PARP drug clears clinical test

The company said Thursday its BRACAnalysis CDx diagnostic will be used to find germline BRCA mutations in men with certain prostate cancers in a Phase 3 study.

By Nick Paul Taylor • Updated April 4, 2019

Verily launches eye disease screening algorithm in India

The company also said the algorithm won CE mark approval, but did not reveal its plans for the technology in Europe.

By Susan Kelly • Feb. 26, 2019

FDA warns breast infrared imaging tool should not replace mammography

Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to support its use in breast cancer screening, the agency said.

By Susan Kelly • Feb. 26, 2019

Philips' camera-guided digital imaging system gets FDA OK

The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.

By Meg Bryant • Feb. 21, 2019

Intuitive gains FDA clearance for Ion lung catheter

The robot-assisted surgery pioneer said it plans a measured U.S. rollout of the system with customer shipments beginning in the second quarter.

By Susan Kelly • Feb. 20, 2019

ACLA, AdvaMedDx clash on lab test overhaul bill

The latest version of draft legislation incorporated suggestions from FDA, including a precertification program. The Pew Charitable Trusts cautioned that may open up patients to risk from unreviewed products.

By David Lim • Feb. 20, 2019

FDA grants breakthrough status to concussion-detecting VR headset

The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.

By Nick Paul Taylor • Feb. 20, 2019

FDA grants breakthrough status to amyloid beta Alzheimer's test

The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.

By Nick Paul Taylor • Feb. 15, 2019

Headwinds stiffen as Quest revenues, earnings miss Q4 estimates

Elements of the fourth quarter financial results align with performance of chief rival LabCorp. Both companies are contending with Medicare rate reductions as a result of PAMA.

By Nick Paul Taylor • Feb. 14, 2019

Software products face high-risk upclassing in Australia

The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.

By Nick Paul Taylor • Feb. 14, 2019