Policy and Regulatory
1. World Economic Forum releases report on diagnostics in LMICs
The new report highlights key issues low and middle income countries (LMICs) face in bringing diagnostics from the laboratory to the patient. It proposes a coordinated global alliance for affordable diagnostics that would learn from other successful global health initiatives, to expand the availability of essential diagnostics in LMICs.
2. NHSX unveils new assessment criteria for digital health technologies
The new criteria builds on a beta version released last year but provides more details. Apps that pass the assessment process will be included in the NHS digital library, a repository of digital health technologies certified safe for NHS use.
3. HAS France publishes classification of digital tools
French health authorities have classified digital tools into 4 risk levels with concrete examples. Practical implications of the framework are yet unclear but may impact regulatory technical and economic assessments in future.
4. France builds digital health acceleration strategy
This will start with a public consultation addressing issues like market access and financing.
The strategy also proposes 5 areas of focus including market access, building trust in e-health through medical practitioner training and drawing insights from big data.
New Products, Partnerships, Discoveries
1. Patients to be offered AI technology which helps detect kidney disease
Patients with diabetes and high blood pressure are benefiting from AI that turns a smartphone camera into a tool which can detect early kidney disease. NHSX is supporting Healthy.io to offer 500,000 patients technology-supported home-testing kits over the next 3 years. More than 3,500 patients have already received their kits.
2. AliveCor, AstraZeneca Partner to Screen for Blood Potassium Levels Via Electrocardiograms
The collaboration will focus on the development of AliveCor’s potassium detection technology through their Kardia-K AI platform, to screen for elevated levels of blood potassium via electrocardiograms.
3. AliveCor Defines its Position in ECG Monitoring Space
Its technology is expanded to include Sinus Rhythm with Supraventricular Ectopy (SVE), Sinus Rhythm with Premature Ventricular Contractions (PVCs), and Sinus Rhythm with Wide QRS.
4. Roche inks deal with Diabeloop to integrate automated insulin delivery
This integration will result in a hybrid closed-loop system – a system designed to take the pressure off the patient to dose glucose, instead of relying on an algorithm for support.
5. Agilent to Acquire Resolution Bioscience, Strengthening Leadership Position in Cancer Diagnostics
The acquisition brings together Resolution Bioscience’s liquid biopsy platform with Agilent’s expertise in tissue-based companion diagnostics.
6. Study: New prostate cancer test can avoid unnecessary biopsies
The urine-based MyProstateScore test provided 97% sensitivity and 98% negative predictive value for grade group ≥2 cancer.
7. Report reveals that adoption of digital pathology is accelerating
Most lab and hospital leaders see the value of digital pathology, but a significant number of pathology professionals are not yet leveraging whole slide scanning, and the large majority rely on sending physical glass slides for secondary consults.
8. Diagnostic Titans Team Up to Enhance Early Cancer Detection
The collaboration calls for Quest Diagnostics to provide phlebotomy services to support Galleri.
The liquid biopsy-based precision test guides patient selection and offers potential for cost-effective, non-invasive alternative to surgical removal of cervical lesions.
10. Novel ddPCR Assay Precisely Measures CAR T-cells After Infusion
A novel quantitative assay used with flow cytometry precisely measures CAR T-cell engraftment and in vivo expansion to predict patient outcomes after CAR T-cell infusion, according to researchers.
11. PGDx to Expand Liquid and Tissue Biopsy Portfolio with Help of New Financing
One of PGDx’s most significant products is the PGDx elio tissue complete. Elio is a clinical next-generation sequencing (NGS) diagnostic kit for comprehensive tumor profiling.
12. Blood biomarker predicts kidney rejection and how to best to manage post-transplant patients
Researchers at the University of Pittsburgh School of Medicine have discovered a blood biomarker that predicts kidney transplant rejection with a lead time of about 8 months, which could give doctors an opportunity to intervene and prevent permanent damage.
13. New wearable patch can monitor blood pressure, caffeine levels
University of California San Diego engineers have developed a skin patch that can be worn on the neck to track blood pressure and heart rate while monitoring the user's glucose, lactate, alcohol or caffeine levels.