Bifogade filer
Devyser strengthens U.S. market presence with CMS pricing for PrenatalDetect RHD test
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Devyser today announced that the Centers for Medicare & Medicaid Services (CMS) has issued its final pricing determination for the company’s PrenatalDetect RHD test (CPT 0536U) at $192. The non-invasive fetal RhD genotyping test is performed at Devyser Genomic Laboratories, the company’s CLIA-certified and CAP-accredited facility in the United States. The pricing will be reflected in the 2026 Medicare Clinical Laboratory Fee Schedule (CLFS) and will take effect on January 1, 2026.
“This achievement marks an important milestone for Devyser Genomic Laboratories. The CMS pricing determination facilitates reimbursement for our PrenatalDetect RHD test and supports our mission to provide innovative, high-quality prenatal diagnostics to expectant mothers” said Jan Wahlström, CEO, Devyser.
Medicare pricing often serves as a benchmark for private insurer reimbursement, paving the way for broader coverage and improved access. This decision also aligns with the 2024 clinical guidelines issued by the American College of Obstetricians and Gynecologists (ACOG), which recommend wider use of fetal RhD genotyping to optimize the limited supply of anti-D immunoglobulin.
“By establishing a competitive price for our PrenatalDetect RHD test, CMS has made this technology more accessible to patients, providers, and payors alike. This will help enable equitable access to high-quality prenatal testing across the healthcare system,” said Theis Kipling, CCO, Devyser.
About PrenatalDetect RHD
PrenatalDetect RHD service offers a highly sensitive and accurate test for non-invasive fetal RHD screening. By determining fetal RHD status from maternal plasma, it provides information on fetal RHD status that may support clinical decision making in Rh-negative pregnant women and help streamline patient testing workflows.
Disclaimer: PrenatalDetect RHD is a laboratory-developed test offered exclusively by Devyser Genomic Laboratories. It was developed and validated under CLIA for high-complexity testing. This test has not been cleared or approved by the FDA. Results should be interpreted with other clinical and laboratory findings.