NEW YORK – Fast MDx announced Wednesday that it has obtained the CE-IVDR mark for a fully automated, high-throughput open molecular diagnostic test system called NGX 124.
The system is slated for official launch later this year, the London-based firm said in a statement.
The NGX 124 was designed in collaboration with Festo, a Germany-based automation specialist, and uses Fast MDx's four-channel qPCR thermal cycler and reverse transcription block technology. The system allows laboratories to automate lab-developed tests and research-use-only assays along with CE-IVDR-marked tests from independent manufacturers.
Fast MDx is considered a social enterprise, CEO Richard Lewis said in the statement, and as such, it intends to provide low-cost molecular testing worldwide. Specifically, the NGX 124 platform is offered free of charge, with a subscription service for tests. The firm estimates that the system will reduce cost of testing, as one Fast MDx platform and one technician provide the same testing capability as five scientists in a traditional, centralized bio-secure lab.
"Providing clinicians quickly with accurate test results will enable them to treat their patients faster and more appropriately than ever before, resulting in better patient outcomes and a large reduction in the use and expense of critical care facilities," Lewis also said.
Fast MDx recently described a business plan involving collaboration with assay developers for menu build-out and comarketing.
Other fully automated medium- and high-throughput PCR systems with open functionalities include Becton Dickinson's BD Max, Bruker's EliTech EliVerse, Hologic's Panther Fusion, Seegene's STARlet-AIOS, the Abbott Alinity M with You-Create feature, and the Roche Cobas Omni Utility Channel. Lower-throughput MDx systems from Cepheid and Biomeme also have programs for incorporating assays created by other developers.