The CE mark advances the firm's strategy to develop and commercialize two- to five-minute tests that use fingerprick blood or stool samples, ProciseDx said.
The Mycartis spinoff is developing a point-of-care device and its first diagnostic test, which will be a urine-based self-test to check for chlamydia and gonorrhea.
The startup is exploring options with potential partners and plans to bring a urinary tract infection test through regulatory channels in the next two years.
Clinical investigators have used Longhorn Vaccines and Diagnostics' qPCR approach in a study to detect M. tuberculosis DNA in the mouths of people at high risk for subclinical TB.
The firm said that after its device is placed on the upper arm, blood collection usually takes between two and three minutes following the press of a button.
The firms noted that QuantuMDx’s Capture-XT technology will enable downstream drug-susceptibility analysis, PCR, NGS, and, with this collaboration, nanopore detection.
The method detects dengue virus from blood serum or plasma using DNA nanostructures and aptamers and can potentially be read with a portable fluoroscope.
Initiatives to develop commercial breath diagnostic systems reveal that developers are trying out lab-based mass spec systems and portable electronic noses.
