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Devyser Fetal Abnormality Test Nabs China Approval; Firm, Thermo Fisher Collaborate on FDA Approval

NEW YORK – Devyser announced Monday that its Devyser Compact genetic test for fetal abnormalities has received Class III approval from China's National Medical Products Administration.

Separately, the company on Tuesday said it has entered into an agreement with Thermo Fisher Scientific to collaborate on obtaining US Food and Drug Administration approval for their co-branded kidney transplant monitoring assay.

The fetal abnormality test that received NMPA approval measures the most common chromosomal abnormalities, including Down syndrome, and includes technology for the safe detection of Turner syndrome. The assay uses a single-tube PCR process to analyze chromosomes 13, 18, 21, and XY with 26 genetic markers, Stockholm-based Devyser said in a statement. The NMPA approval allows Devyser to market Devyser Compact as an in vitro diagnostic in China.

Class III products are the highest-risk medical devices in China.

The test received certification under Europe's In Vitro Diagnostic Regulation in 2023.

"Based on this regulatory approval, we are optimistic about the potential of this product in China," Devyser CEO Fredrik Alpsten said in a statement. "This first product approval by the NMPA gives us confidence that several more products will be approved in the future in China."

Meanwhile, Devyser and Thermo Fisher will work together to get FDA approval on their co-branded next-generation sequencing-based One Lambda Devyser Accept cfDNA test that detects donor-derived cell-free DNA in blood samples from kidney transplant patients. Thermo Fisher is the exclusive distributor of Devyser's transplant products, including the One Lambda Devyser Accept cfDNA test and One Lambda Devyser Chimerism for screening and follow-up post-stem cell transplantation, Devyser said in a statement.

Both tests received certification under Europe's In Vitro Diagnostic Regulation last year.

The collaboration "is a great opportunity for us to combine the strengths of both companies to fast-track studies and complete the necessary regulatory activities to obtain FDA approval in the shortest time possible," Alpsten said in a statement. "With Thermo Fisher's expertise and experience working with regulators, we are confident that this collaboration will secure the most efficient pathway for FDA-approval of our post-transplant product in the US."

Alpsten added via email that the companies will collaborate on the total FDA program, including cost sharing. They will work together on preclinical and clinical activities leading up to the FDA submission, including interactions with the FDA.

Financial and other terms of the deal were not disclosed.