What’s hot in (digital) diagnostics? – News in bullets, June - 2020

Exciting (NON-Covid19) news flash from the world of (digital) diagnostics from market access, policy, product launches, start-ups and industry trends perspectives.

Europe’s Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR)

• European Commission lays out timeline for next steps toward MDR, IVDR

• TÜV SÜD becomes 4th notified body designated under IVDR

Reimbursement Developments

• Myriad prostate cancer test wins coverage from Aetna

• CMS establishes preliminary reimbursement for PAVmed esophageal cancer test

M&A/Partnerships

• Illumina Acquires BlueBee to Accelerate Processing, Analysis and Sharing of Next Generation Sequencing Data at Scale

• Invitae and ArcherDX to create a global leader in comprehensive cancer genetics and precision oncology

• Siemens Healthineers, Geisinger Partner to Boost Digital Healthcare

New Evidence

• Myriad Genetics Announces Publication of a Prospective Clinical Study of the EndoPredict® Test in Women with Early-Stage Breast Cancer

• Exact Sciences Showcases Continued Progress in Cancer Diagnostics at ASCO 2020

New Products

• Thermo Fisher, MedRhythms gain breakthrough device designations

• A novel approach to detecting Alzheimer’s early: Oxford Brain Diagnostics

• Thermo Fisher Scientific, Daiichi Sankyo Partner to Develop Non-Small Cell Lung Cancer CDx