Diagnostics
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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. 07, 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. 07, 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. 02, 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. 02, 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. 01, 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 -
Abbott teases FreeStyle Libre potential beyond glucose monitoring
The company is expanding manufacturing of its blockbuster diabetes device, a technology CEO Miles White said could be expanded to track other analytes.
By Maria Rachal • July 17, 2019 -
Hospitals may boost outsourcing of lab services: UBS poll
LabCorp may benefit most from the increasing use of service providers, with nearly 10% more respondents expressing interest in working with the company over rival Quest Diagnostics.
By Nick Paul Taylor • July 17, 2019 -
Screenings fail to explain rise in colorectal cancer in younger adults, study finds
The American Cancer Society called for further study of the trend, saying factors beyond expanded use of colonoscopy testing may play a role in driving the increased incidence of colorectal cancer.
By Susan Kelly • July 15, 2019 -
WHO expands lists of essential in vitro diagnostics
New additions include 12 tests for detection of solid tumors like colorectal, liver, cervical, prostate, breast, germ cell and blood cancers, as well as lymphomas.
By Susan Kelly • July 10, 2019 -
Fitch Solutions tips Roche to challenge Philips for digital pathology market
After enjoying a brief monopoly, Philips faces a clutch of competitors planning regulatory filings.
By Nick Paul Taylor • July 10, 2019 -
Investment firm downgrades Myriad Genetics as growth thesis weakens
Cowen analysts made the decision in light of back-to-back quarters in which sales of key products fell short of expectations.
By Nick Paul Taylor • July 10, 2019
