The saliva test developed by the start-up Ziwig, which was narrowly missed for long-term reimbursement at the start of the year, finally obtained access to the innovation package.
By Sophie HOGUIN, published on October 19, 2024
Biologiste infos has been following the Ziwig company for a long time now and in particular its flagship test for endometriosis, the request for coverage of which was refused by the HAS in January 2024 – despite a clear interest from the HAS (see this article).
Perseverance is the mother of success
However, Ziwig did not give up and this time his request for support was successfully accepted as part of the innovation package. A press release dated October 18, 2024 confirms that “The High Authority for Health (HAS) issues a favorable opinion on the coverage of the Endotest saliva test as part of the innovation package. The clinical study carried out in this regard will make it possible to provide early and secure access to the test and to collect missing data for future evaluation for common law treatment..”
Support from HAS
In a context of reviewing access to the RIHN and making innovations available to patients more quickly, HAS has underlined in recent weeks that it is structuring more intensively the support of innovative companies in construction and construction. submission of their file.
The institution thus explains in its press release that despite a marked innovative character: “The clinical data available during its first evaluation by the HAS last January were insufficient to conclude in particular that it had a favorable impact on patient care. HAS therefore invited the manufacturer to submit an application for an innovation package for Endotest and thus allow a population of patients to access it as quickly as possible. She supported the manufacturer in developing a sufficiently robust clinical study protocol to meet the requirements for entry into the device..” The conditions having now been met, the favorable opinion could be delivered.
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