Policy and regulatory
EU expert panel starts accepting applications to review high-risk IVDs
A panel of experts convened by the European Union to evaluate the performance of high-risk in vitro diagnostics has begun accepting applications from notified bodies.
TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark
Germany: Economists recommend a new form of hospital funding
Among ideas being discussed is a quality premium, which rewards hospitals based on the quality of services provided
Germany: Growing popularity of digital health applications
AOK Plus has enabled more than 1,900 people to use reimbursed digital health applications since Oct 2020.
Companies, new products, joint ventures
Illumina and Merck team up to ID cancer mutations
The companion diagnostic will identify genetic mutations used in the assessment of homologous recombination deficiency as such tumours may be treated with PARP inhibitors
Medial EarlySign signs deal with Roche to develop AI-enabled cancer detection tool
The new initiative will begin with a focus on gastric cancer.
Science 37 teams up with Roche’s Foundation Medicine to boost home-based oncology trials
Being able to do some of the trial work such as follow-ups and checks from a subject's home could boost recruitment and retention.
Hong Kong-based Prenetics to go public in US as part of $1.25B SPAC merger
The company is looking to expand in consumer genetics, colorectal cancer screening and COVID 19.
Abbott, Quest, Quidel scramble to add test capacity as delta variant surges
The diagnostics industry is racing to add capacity as the delta-driven surge in COVID-19 cases increases demand for PCR tests and at-home rapid antigen kits.
FDA warns of false positive risk of Abbott Covid 19 test
The advice applies to the Abbott Alinity lab test. FDA is asking users to consider "retesting positive patient specimens performed in the last two weeks with an alternate authorized test."
Apple looks to digital biomarkers for depression, cognitive decline
The goal is to create a new Apple feature that would tell users if there was a potential mental illness.
Novo Nordisk Foundation teams up with Broad Institute, Harvard for diabetes, obesity research hub
The new hub aims to explore the genetics and gene regulation of common yet complex diseases, with an early focus on Type 2 diabetes and obesity
Invitae to buy health records startup Citizen for $325 million
Combining the two companies would allow patients to access genetic testing and their health records in one place
Beckman Coulter launches new device reducing time for PCR cleanup
PCR cleanup can also be achieved in 16 minutes, down from 30 minutes expediting and improving bead mixing and separation.