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Diagnostics Business, Policy & Funding

Breaking news on Diagnostics business, policy & funding.

Takeda, MiTest Health Partner to Expand Use of Crohn's Disease Risk Prediction Tool

Takeda said that the tool evaluates risk for developing complications associated with Crohn's disease and helps support personalized clinical decision-making.

NIH Awards $102.5M for Antibacterial Resistance Research, Dx Development

The seven-year grant renews funding for the Antibacterial Resistance Leadership Group, led by Duke University and UCSF, with $15 million in 2020.

Tempus Acquires Commercial Lab, Precision Medicine Services Provider Akesogen

Tempus said that Akesogen's lab provides a range of testing services, including for inherited risk of cancer, microbiome profiling, whole-genome genotyping, and more.

EU Group Issues New IVD Guidelines

The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.

Luminostics' Luminescent Particle Lifts Sensitivity in OTC Test Prototypes

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The firm said it is turbocharging the lateral flow format with sensitivity and cost suitable for over-the-counter STI testing.

Dec 12, 2019

Pass-Through Lab Billing Arrangements Draw Payor Scrutiny, Ire

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Dec 12, 2019

PerkinElmer's Muscular Dystrophy Screening Kit Receives FDA Marketing Authorization

Dec 12, 2019

SQI Diagnostics Q4 Revenues Rise 14 Percent

Dec 11, 2019

GenMark Diagnostics Downgraded by JP Morgan to Neutral

Dec 11, 2019

Parkinson's Foundation Selects Five Sites for Genetic Testing, Counseling

Dec 11, 2019

Proscia, Johns Hopkins Collaborate on AI for Pathology

Dec 10, 2019

Nanomix Readying Multimarker Sepsis Test for Use at Point of Care

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Dec 10, 2019

Enzo Biochem Fiscal Q1 Revenues Down 5 Percent

Dec 10, 2019

Seventh Sense Biosystems Gets FDA Clearance for At-Home Blood Collection Device

Dec 10, 2019

Invitae, BioMarin Partner on Access to Genetic Testing for Skeletal Dysplasias

Dec 10, 2019

Biotia Raises $2.4M in Seed Financing

Dec 10, 2019

Roche Blood Glucose Monitor App Receives CE Mark

Dec 09, 2019

Quest Diagnostics Prices $800M Offering of Senior Notes

Dec 09, 2019

StageZero, Oncore Pharma Expand Test Deal

Dec 09, 2019

Former Diagnostics Executive Ordered to Pay $443K for Defrauding Investors

Dec 09, 2019

Biocept Prices $10M Public Offering of Stocks, Warrants

Dec 06, 2019

Local Coverage Determinations Roundup: Transplant Genomics, Opko Health

Dec 06, 2019

Inspirata, DeePathology Partner on AI-Based H. Pylori Pathology Testing

Dec 06, 2019

BioMérieux, Beckman Coulter, Siemens Healthineers, Others Get 510(k) Clearances in November

Dec 06, 2019

Sienna Cancer Diagnostics Raises $1.1M in Private Placement