2023-09-14 14:00:00
The ANSM warns regarding the supply of screening tests for Down syndrome
L’ANSM has communicated regarding a risk regarding the supply of Down syndrome screening tests, distributed by PerkinElmer. The supplier informed the agency of a supply shortage on free beta HCG assay reagents, one of the devices used in France for this prenatal test.
PerkinElmer France implemented a delivery quota and informed its users that its reagent kits only had one vial of tracer instead of two, a quantity however sufficient to carry out the tests. The company thus indicates that it will be able to cover needs until the end of 2023, and hopes for a return to normal by 2024. For its part, the ANSM affirms “closely monitor the evolution of the situation in order to reduce its potential impact” and be at “search for alternatives to alleviate the tension and guarantee access to this screening for all pregnant women in France. »
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Combined with an ultrasound, the analysis of serum markers by blood test makes it possible to provide an initial assessment of the risk of Down syndrome, during the third month of pregnancy.
France Biotech supports digital medical devices
L’association France Biotech announces the launch of a task force dedicated to digital medical devices for therapeutic purposes. This might be, for example, a mobile application or a connected device for patient monitoring. This type of device is used for many illnesses, for mental disorders or sleep disorders as well as for chronic illnesses.
However, these innovations raise many questions that the France Biotech working group wishes to address. “Today, we must co-construct with the public authorities the regulatory framework for this sector to allow entrepreneurs to quickly and clearly access the market, with the definition of reimbursement terms”estimates Alexandre Prihnenko, general director of Oviva and in charge of task force for France Biotech. « Notre task force aims to play a catalytic role in the facilitation and structuring of this sector”he aims.
Unicancer partners with Quinten Health to develop a digital patient twin
The network of cancer centers Unicancer associates with Quinten Health, French specialist in data and AI applied to health. This public-private partnership will be intended to develop a patient simulator. The design of this digital twin aims to both reduce risks and accelerate clinical trials on lung cancer, a pathology in which success remains rare.
“Industrialists will have the opportunity to optimize the design and implementation of clinical trials in a more precise manner, by more effectively anticipating the integration of new treatments into the patient’s care pathway”explique Billy Amzal, p-dg de Quinten Health. “Thanks to data and experts from the Unicancer network, we will train our algorithms to model and simulate this complexity in order to reduce uncertainties and development costs”underlines Alexandre Templier, president of Quinten Health.
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