Diagnostics Business, Policy & Funding

Breaking news on life science and diagnostics business, policy, and funding

Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework

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Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.

Abbott HbA1c Test FDA Cleared to Diagnose Diabetes

The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.

Cigna to Cover GenomeDx's Decipher Prostate Cancer Tests

Cigna is the first national private payor to provider coverage for the Decipher tests, which provide a genomic assessment of tumor aggressiveness.

Beckman Coulter Dx, UCI Collaborate on Clinical Applications

The collaboration will give the company access to UCI research in diagnostic platforms, life science applications, devices, and data analytics.

FDA Clears DiaSorin HSV Assay for Extended Swab Sample Claims

With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.

Jun 20, 2018

Health Canada Licenses Beckman Reproductive Health Assay

Jun 19, 2018

Genetic Technologies, Swisstec Reach Deal on JV

Jun 19, 2018

Grifols Gets FDA Clearance for Two Blood Screening Assays on Procleix Panther System

Jun 19, 2018

FDA Will Not Require LOINC Codes in Diagnostic Device Documentation

Jun 19, 2018

Natera, Institut Jules Bordet Ink Breast Cancer Research Collaboration

Jun 19, 2018

Roche to Acquire Outstanding Shares of Foundation Medicine for $2.4B

Jun 18, 2018

Health Canada Approves Hologic Panther Fusion System; Flu, Respiratory Assays

Jun 18, 2018

PerkinElmer Receives FDA Clearance for Lupus Dx Tests

Jun 18, 2018

Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx

Jun 15, 2018

Theranos' Holmes and Balwani Indicted For Alleged Wire Fraud Schemes

Jun 14, 2018

Janssen Plans Year-End Erdafitinib Filing Based on Phase II Data in FGFR-Mutated Bladder Cancer

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Jun 14, 2018

Bühlmann Labs Gets FDA Clearance for Calprotectin Inflammatory IBD Assay

Jun 14, 2018

UK Seeks to Advance Digital Pathology, Medical Imaging With £50M in Funding

Jun 14, 2018

Clinical Genomics Licensed in California

Jun 13, 2018

Inspirata Buys Caradigm From GE Healthcare

Jun 13, 2018

FibroTx, Leo Pharma Collaborate on Use of Biomarker Skin Test

Jun 13, 2018

FDA Clears Gold Standard Diagnostic Lyme Disease Assay

Jun 12, 2018

Akcea, Ambry Genetics to Launch Genetic Testing Program for ATTR Amyloidosis

Jun 12, 2018

Enzo Biochem Q3 Revenues Drop 5 Percent

Jun 12, 2018

FDA Clears Fujirebio Diagnostics G BRAHMS Procalcitonin Assay