Coverage, Policy, Regulatory
1. European Parliament extends transition periods for in-vitro diagnostics
The European Parliament decided on extended transition periods for certain IVDs. Goal to avoid bottlenecks and ensure that patients, hospitals and research institutions continue to receive necessary tests in sufficient numbers.
2. Maximum amount regulation for DiGA framework agreement
The DiGA pricing was further clarified: The determination of max. reimbursement amounts will account for the different indication groups (ICD-10). Quantity-specific discounts will also apply. The calculations should be made every six months by a specialist committee.
3. Digital Supply and Care Modernization Act (DVPMG) - final draft
The Digital Supply and Care Modernization Act (DVPMG) further boosts telematics infrastructure (TI), expands the functions of the electronic patient record (ePA), expands remote treatment, and carries out digital care applications (DiPAs).
Initiatives, companies, products
Enterprise software giant Oracle buys electronic medical records company Cerner in an approximately $28.3 billion in equity value, one of the largest takeovers of 2021.
5. Labcorp to Acquire Personal Genome Diagnostics for up to $575M in Cash
Laboratory Corporation of America has agreed to acquire cancer genomics firm Personal Genome Diagnostics. (PGDx)
6. Foundation Medicine Test Nabs FDA Approval as CDx for BRAF Inhibitor Therapeutics for Melanoma
Roche's Foundation Medicine announced that the FoundationOneCDx test has been approved by the FDA as a companion diagnostic for two groups of BRAF inhibitor therapies for melanoma.
7. Boehringer invests again in AI diagnosis specialist Brainomix
UK digital health company Brainomix has raised £16 M ($21.5 M) that will be used to extend the use of its AI-based medical imaging software for stroke to new therapeutic areas.
8. Freenome Raises $300M in Series D Financing
The new funds will help support the advancement of its blood-based colorectal cancer screening test, currently being validated in a prospective registrational study.
9. BD to invest over €70m in Limerick research centre
The investment will further position the facility as a hub for the development of smart connected health and infection monitoring solutions in clinical and non-clinical settings.
10. AstraZeneca and G42 Healthcare partner to boost research and diagnostics in the UAE
AZ announced a partnership with G42 Healthcare – a subsidiary of Abu Dhabi’s AI and cloud computing business, G42 – to explore real-world evidence and conduct clinical trials through Insights Research Organization & Solutions (IROS).