Exciting news flash from the world of (digital) diagnostics from market access, policy, product launches, start-ups and industry trends perspectives.
Policy and Regulatory
1.German hospitals get €3 billion funding boost for digitalisation (in German)
The Hospital Future Act aims to modernise the country’s hospital system
2. First contours for the third digitisation law in Germany (in German)
First discussions about the law to expand the use of telemedicine and include (nursing) care apps, DiPAs (Digitale Pflegeanwendungen).
3. UK NHSX launches assessment criteria for digital health tools
NHSX has launched in beta, a Digital Technology Assessment Criteria (DTAC) to set out how digital health and social care technologies will be assessed.
4. France publishes rapid review of Covid antigen tests (in French)
The document also contains an organizational impact model that allows assessment of relevance of replacing RT-PCR tests with antigen tests.
5. France sets up platform to help start-ups in e-health landscape and financing (French)
The GNius platform helps innovators learn about applicable regulations, understand the healthcare ecosystem and identify sources of funding in a one-stop shop.
6. EU notified body designation pipeline points to IVDR bottleneck
Few notified bodies (institutions in charge of issuing IVDR regulatory certification) are likely to join the four already designated. Is there enough manpower to implement IVDR approvals by May 2022?
7. AdvaMed Pushes For US Medicare Coverage of Digital Health Tech
The medtech trade group is calling the US Centre for Medicare and Medicaid (CMS) to test new payment and delivery models that integrate digital health technologies, amongst other requests in a new white paper.
New Reimbursements
1.3 more biomarker tests in breast cancer to aid decision-making in Germany (German)
Breast cancer diagnostics Endopredict, MammaPrint and ProSigna should be added to the German list of reimbursed tests soon to help support the patient's decision for or against chemotherapy after an operation. Oncotype Dx, a similar diagnostic, is already reimbursed.
2. 5 apps awarded temporary or permanent reimbursement in Germany (German)
The DiGA registry is now published and as of Nov 3, five applications were listed.
3. US CMS expands list of telehealth services that can get Medicare reimbursement
The Centers for Medicare & Medicaid Services (CMS) has added 11 new telehealth services that Medicare will reimburse, including cardiac rehabilitation services.
New Products, Partnerships, Discoveries
1.Big Data Dashboard Could Optimize Cancer Clinical Decision Support
The Navify Tumour Board, developed with Roche Diagnostics, reduced 30 percent preparation time across three cancer categories with full integration compared to pre-implementation.
2. Fitbit ECG app now cleared for AFib Detection
Fitbit recently announced that the Fitbit ECG App now has both FDA 510(k) clearance and CE marking to analyze user heart rhythm for atrial fibrillation (AFib)
The trial utilises NGS and was designed to evaluate targeted therapy antitumor activity in underexplored cancer types.
4. FoundationOne CDx Wins Approval as Companion Diagnostic to Vitrakvi
FoundationOne CDx will be used as a companion diagnostic for Eli Lilly’s Vitrakvi (Bayer took full control of Vitrakvi, in a deal with Eli Lilly’s Loxo Oncology) which treats patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion and other special conditions.
Roche diagnostics and start-up Babyscripts team up on remote patient monitoring allowing doctors to detect pregnancy risks more quickly and automate elements of care.
Mergers and Acquisitions, Financial Results
1.Exact Sciences buys cancer detection company Thrive for $2.15 billion
The company is positioning itself as a leader in the cancer screening market.
2. Thermo Scientific Sees Significant Growth Due to COVID-19 Test Demand
The company brought in about $8.5 billion in revenue for the quarter, which was a 36% increase year-over-year.