Founded last year, the company plans to develop mass spec-based tests to protein isoforms using a workflow that eliminates both LC and protein digestion.
The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.
The study found that for some patients the standard practice of performing a second confirmatory blood test is not necessary, which could streamline care.
The researchers have launched a firm to commercialize the approach, which detects disease using protein networks encased in phospholipid bilayer membranes.
The companies will comarket an offering that includes Siemens Healthineers' DCA Vantage Analyzer for HbA1c testing and Clinitek Status + Urine Chemistry Urine Analyzer.
The researchers improved diagnostic sensitivity one hundredfold by moving the source of terahertz waves close to a biological sample in a microchannel.
