Prescient gets FDA breakthrough status for colorectal cancer test

If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.

By Nick Paul Taylor • Sept. 5, 2019

Laboratory for Advanced Medicine's liver cancer test gets FDA breakthrough tag

The company secured the status after showing the test detects hepatocellular carcinoma with a specificity and sensitivity in excess of 95%.

By Nick Paul Taylor • Sept. 4, 2019

Explore the Trendline➔

Top 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

Abbott touts potential of 15-minute concussion detection

Highlighting research from the TRACK-TBI study, the company said its in-development point-of-care test could help diagnose concussion in patients whose CT scans miss signs of mild traumatic brain injury.

By Maria Rachal • Aug. 27, 2019

Pharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.

"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.

By Graison Dangor • Aug. 27, 2019

Lawmakers to update VALID this fall, but industry still clashing over details

With Republican Sen. Richard Burr as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development Act in the coming months, multiple sources familiar with the issue told MedTech Dive.

By David Lim • Aug. 26, 2019

Medicare draft decisions may boost Natera, Myriad tests

Cowen analysts called proposed local coverage for Natera's colorectal cancer test as "materially broader and quicker than expected," while documents on pharmacogenomic tests gave a mixed outlook for Myriad Genetics' products.

By Nick Paul Taylor • Aug. 23, 2019

FDA scolds diagnostic manufacturer over production practices

An early 2019 inspection of Polymer Technology Systems' operations prompted regulators to conclude the company had failed to inform FDA of certain reportable events, among other production process shortcomings.

By Nick Paul Taylor • Aug. 22, 2019

US task force expands recommended BRCA test population

The Preventive Services Task Force's update potentially boosts business for Myriad Genetics and other BRCA test makers.

By Nick Paul Taylor • Aug. 21, 2019

Senators push HHS for details of response to DNA test scam

Lawmakers propose pre-claim review of genetic test orders to root out fraud.

By Nick Paul Taylor • Aug. 15, 2019

'Unprecedented' pricing pressures on Myriad send shares plunging

The challenges for GeneSight, the company's genetic depression test, were only the beginning of its woes during the quarter.

By Nick Paul Taylor • Aug. 14, 2019

Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study

Researchers hope the liquid biopsy test, which demonstrated high accuracy in detecting residual disease in a small study, can help breast cancer patients avoid unnecessary surgeries.

By Susan Kelly • Aug. 12, 2019

Guardant Q2 sales soar on liquid biopsy adoption

The company touted results this week from a study showing its blood-based Guardant360 assay compared favorably to standard-of-care tissue testing of solid tumors for a biomarker used to predict response to immunotherapy.

By Susan Kelly • Aug. 7, 2019

iCubate lung infection test secures FDA breakthrough status

The in vitro diagnostics maker said it can accelerate diagnosis and treatment of a disease that affects more than 80,000 people in the U.S.

By Nick Paul Taylor • Aug. 7, 2019

Data breaches in 2019 already double all of last year

The single largest data breach stemmed from a hack of a major medical collections agency working for companies including Quest and LabCorp, the report from Protenus found. Twenty million patient records were affected.

By Rebecca Pifer • Aug. 2, 2019

UnitedHealthcare's depression test decision boosts Myriad's prospects

While Medicare only permits psychiatrists to order the test, the private payer will reimburse requests from all providers.

By Nick Paul Taylor • Aug. 2, 2019

DeepMind AI shows potential to accelerate kidney injury diagnosis

The Google sister company trained artificial intelligence to predict when patients are likely to develop acute kidney injury within the next 48 hours.

By Nick Paul Taylor • Aug. 1, 2019

Appeals court kicks ACLA lawsuit back to lower court

The ruling is a blow to the government, which argued collection of market data was inextricably intertwined with the establishment of payment rates and therefore wasn't reviewable by the courts.

By David Lim • July 31, 2019

FDA clears Lyme disease tests, ending reliance on immunoblots

Zeus Scientific won the clearances after convincing the agency using enzyme immunoassays alone is as accurate as the current two-tiered approach.

By Nick Paul Taylor • July 30, 2019

Exact Sciences to gain breast, prostate cancer tests in $2.8B deal

The Cologuard maker is adding Genomic Health's Oncotype DX tests to its ranks, which together target a market worth an estimated $20 billion.

By Maria Rachal • July 29, 2019

Consumer genetics dip drives LabCorp Q2 test volumes down

The 1.2% decline in organic diagnostic volume contrasts growth achieved by rival Quest. PAMA and managed care contracts also weighed on results.

By Nick Paul Taylor • July 25, 2019

PCORI, MD Anderson team up on lung cancer screening aid

Funded by the Patient-Centered Outcomes Research Institute, the project targets high-risk smokers for lung cancer screening. A second program looks to expand care for adolescents with behavior problems after traumatic brain injury.

By Susan Kelly • July 24, 2019

Quest reports volume growth despite loss of contracts

Executives at the lab testing giant disclosed it lost a few capitated contracts open for renewal during the second quarter due to a competitor offering lower rates than were profitable.

By David Lim • July 23, 2019

Medtronic to distribute AI stroke detection and triage software

The technology comes from Google Ventures-backed artificial intelligence startup Viz.ai, which won a De Novo clearance last year for its clinical decision support software aimed at speeding identification of large vessel occlusions.

By Maria Rachal • July 22, 2019

HER2 breast cancer imaging tech gets breakthrough nod

Imagion Biosystems is developing an alternative imaging system it hopes will speed cancer detection with the use of magnetic nanoparticles injected into the body to hunt for tumors.

By Susan Kelly • July 22, 2019

Random plasma glucose testing helps predict diabetes in large VA study

Department of Veterans Affairs researchers combing data from nearly 1 million patients found routine blood tests to be an overlooked but effective means of identifying patients at risk of developing the disease within five years.

By Susan Kelly • July 22, 2019