Diagnostics Business, Policy & Funding

Breaking news on Diagnostics business, policy & funding.

Avellino Labs Gets CLIA Certification

With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.

Exact Sciences, Mayo Clinic Launch Real-World Impact Study for Cologuard

The Voyage study is designed to enroll more than 150,000 people and will follow participants for at least seven years.

William Blair, Cowen Initiate Coverage of Exagen

The investment banks cited the company's access to proprietary technology and the potential $5 billion market for Exagen's testing options as reasons for its Outperform rating.

Novigenix, RadioMedix to Develop Neuroendocrine Cancer MDx

The companies will develop an assay to guide treatment with a type of radiopharmaceutical therapy in patients with these rare tumors.

Yourgene Health H1 2019 Revenues Double

The company said the revenue growth was driven by growing international demand for its noninvasive prenatal testing products and services.

Oct 14, 2019

Germany's Dekra Becomes First Notified Body Designated Under New IVDR

Oct 11, 2019

OraSure Technologies Rapid Ebola Test Granted Marketing Authorization by FDA

Oct 11, 2019

New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests

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Oct 11, 2019

Dialysis Firm Fresenius to Pay $5.2M to Settle Improper Medicare Billing Allegations

Oct 11, 2019

Transplant Genomics Kidney Transplant Test Gets Final Medicare Coverage Decision

Oct 10, 2019

Bio-Techne Receives Medicare Coverage for Prostate Cancer Test

Oct 10, 2019

Oncore Pharma Signs European Marketing Deal for Colorectal Cancer Test

Oct 10, 2019

FDA Issues Final Guidance on IVD Reviews for Investigational Cancer Drug Trials

Oct 10, 2019

Biofidelity Awarded £500K Innovate UK Grant to Develop Noninvasive MDx Tools

Oct 10, 2019

UTC Labs, Principals Agree to Pay $42.6M in PGx Testing Fraud Case

Oct 10, 2019

FYR Diagnostics Wins $618K NIH Grant to Develop Acquired Epilepsy Assay

Oct 09, 2019

BioMérieux, Philips Electronics, Beckman Coulter, Others Get 510(k) Clearances in September

Oct 09, 2019

Beckman Coulter's DxA 5000 Lab Automation Solution Receives FDA Clearance

Oct 09, 2019

Mobidiag Gets CE Mark for Intestinal Parasites Test

Oct 09, 2019

Sekisui Diagnostics Receives FDA Clearance, CLIA Waiver for Influenza Test

Oct 08, 2019

Brain Cancer Triage Tool May Reduce Unnecessary Scans, Study Says

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Oct 08, 2019

New Diagnostic Platform Being Developed to ID Antimicrobial Susceptibility in Five Hours

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Oct 08, 2019

ProciseDx, Lumiphore Ink Partnership for Rapid Point-of-Care Tests

Oct 08, 2019

Novogene, Chipscreen Ink CDx Development Deal

Oct 08, 2019

Serosep, Quidel Ink US Distribution Deal for GI Panel