Diagnostics

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
GenomeDx pays $2M to settle genetic test false claims allegations

The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.

By Nick Paul Taylor • Feb. 13, 2019
Industry strikes back at GAO's 'flawed and dangerous' PAMA report

AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.

By Nick Paul Taylor • Feb. 13, 2019
Rapid test for brain injury gets FDA breakthrough status

The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.

By Susan Kelly • Feb. 12, 2019
LabCorp diagnostics' operating income tumbles as PAMA hits home

Reimbursement changes wiped $18 million off LabCorp's adjusted operating income, contributing to a 22% drop at the diagnostics unit.

By Nick Paul Taylor • Feb. 07, 2019
FDA categorizes Edwards' cardiac diagnostic recall as Class I event

Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.

By Nick Paul Taylor • Feb. 07, 2019
Cognoa's autism devices win breakthrough status

The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.

By Nick Paul Taylor • Feb. 06, 2019
Healthcare groups urge CMS to keep coverage of NGS cancer tests

Sixty-three healthcare companies and organizations argued the agency's approach to covering next generation sequencing will restrict cancer patients' access to essential tests.

By Susan Kelly • Feb. 05, 2019
Oxipit AI-based tool for chest X-ray analysis gets CE mark

The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.

By Susan Kelly • Feb. 04, 2019
Deep Dive
Clinical lab lobbying spikes as PAMA cuts kick into effect

Paralleling CMS payment cuts that took effect at the start of last year, lobbying by Quest Diagnostics, LabCorp and the American Clinical Laboratory Association jumped to $4.4 million, up from $2.5 million in 2017.

By David Lim • Feb. 01, 2019
FDA approves OPKO's point-of-care PSA test

The immunoassay provides quantitative prostate-specific antigen results within 15 minutes, eliminating the need to send samples to laboratories.

By Nick Paul Taylor • Feb. 01, 2019
FDA sets neurology, microbiology device panel meetings for March

Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.

By Maria Rachal • Jan. 31, 2019
Breast health and diagnostics drive Hologic to beat-and-raise quarter

Double-digit growth by Hologic's core businesses offset ongoing underperformance by its Cynosure medical aesthetics unit.

By Nick Paul Taylor • Jan. 31, 2019
Thermo Fisher posts 16% yearly sales growth, 7% specialty diagnostics bump

Some analysts sought more bullish 2019 goals. But company executives are waiting to see how Brexit, the U.S. trade war with China and other tariffs play out.

By Maria Rachal • Jan. 30, 2019
FDA awards breakthrough status to blood test for Alzheimer's risk

Developers at St. Louis-based C2N Diagnostics think the IVD will make broad screening of patients with early memory problems practical and affordable.

By Nick Paul Taylor • Jan. 30, 2019
Philips hits sales targets despite headwinds and patchy performance

The trade war between the United States and China is taking a toll on the multinational conglomerate.

By Nick Paul Taylor • Jan. 29, 2019
Deep Dive
Why home health tech is capturing investment in 2019

Startups and established providers alike are looking at the potential for devices and technology to help patients manage and receive their treatments from the comfort of home.

By Meg Bryant • Jan. 28, 2019
Top Senate Republican seeks HHS answers on lab payments

The Government Accountability Office stands by its report finding that CMS could end up paying billions more than intended for lab services.

By David Lim • Jan. 28, 2019
Thermo Fisher expands peanut allergy test menu

The company hopes the assay will lead to more tailored, effective allergy management strategies.

By Nick Paul Taylor • Jan. 24, 2019
Illumina TruSight assay gets FDA breakthrough designation

The DNA sequencing company is seeking clearance of the assay as a companion diagnostic.

By Susan Kelly • Jan. 23, 2019
Hereditary colorectal cancer screen is 23andMe's latest FDA nod

The test will look at the two most common genetic variants influencing MUTYH-associated polyposis, which can indicate heightened risk for cancers of the colon, rectum and thyroid.

By Maria Rachal • Jan. 23, 2019
Abbott misses sales expectations despite device, diagnostic unit growth

The medical device unit had the strongest quarter of four divisions, with double-digit growth in sales of diabetes, electrophysiology and structural heart products fueling its performance.

By Nick Paul Taylor • Jan. 23, 2019
J&J to study Apple Watch with heart health app

That medtech giant said it would investigate how the product can be used by seniors to flag atrial fibrillation and prevent stroke in conjunction with a J&J heart health app.

By Maria Rachal • Jan. 18, 2019