Exciting (NON-Covid19) news flash from the world of (digital) diagnostics from market access, policy, product launches, start-ups and industry trends perspectives.
Policy and Regulatory
1. FDA establishes Digital Health Centre of Excellence
Regulators worldwide may take cue from this new FDA initiative. The centre is intended regulate digital health, advance industry best practices whilst providing technological advice.
2. Medical devices sold in Great Britain to require a new UK product safety marking
Post-Brexit guidance published by the Medicines and Healthcare Products Regulatory Agency states the UK Conformity Assessed mark will be required from July 2023.
3. MedTech AI and Software Regulation in China: 5 Things to Know
Regulators are adapting to a new digital era worldwide, including giant of the East, China
Mergers and Acquisitions
1. Illumina inks $8B Grail buyout for liquid biopsy market. Investors are not sold
Illumina has agreed to acquire Grail for $8 billion in a deal that could establish the sequencing giant as a leading player in the liquid biopsy market. Its shares fell reflecting market sentiment.
2. Qiagen completes takeover of PCR automation player NeuMoDx for $248M
NeuMoDx is now working to apply the platform to flu, respiratory syncytial virus and the novel coronavirus, three pathogens that will be circulating soon with similar symptoms.
New Products, Partnerships, Discoveries
1. Roche adds remote monitoring to its diabetes care platform
Doctors and care team members can enroll patients on remote monitoring programs and personalize it according to the length of program, data frequency required etc.
2. Harmonisation of the Essentials: Matching Diagnostics to Treatments for Global Oncology
This recently published paper presents the harmonization of the WHO’s Essential Diagnostics List (EDL) to the Essential Medicines Lists (EML) for cancer diagnostics, ensuring that countries have the right tools to diagnose and thus prescribe medicines.
3. Singapore partners with Apple on new health app to promote lifestyle changes
A digitally advanced country partners a tech giant to introduce a health app rewarding citizens for healthy behavior. Data collected can be used to further tailor national health interventions.
4. Apple launches asthma study with Anthem
The 2-year randomized controlled trial will involve 900 patients from customers of health insurance Anthem or affiliated plans.
5. Siemens Healthineers to Develop Assays for Novartis’ Therapeutics
First off the blocks is a collaboration to develop a serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis and other neurological diseases.
6. Personalised Therapy for Prostate Cancer is Approaching (In German)
Patients with the gBRCA2 deletion fared worse than those without. The prognosis was even worse if patients had the RB1 deletion or MYK amplification in addition.
7. Baxter and BioMerieux in Exclusive Distribution Pact for Acute Kidney Injury Test
Both companies will share in-country commercialization in US and Europe, while BioMérieux will retain control over the regulatory approval process.
The company’s new nine-month start-up accelerator is focused on the Europe, Middle East and Africa (EMEA) region.