The immunofluorescence assays support the detection of anti-double-stranded DNA, which is a marker for systemic lupus erythematosus.
In an initial study, they tested an algorithm based on measurements of IgG and IgM antibodies and levels of C1q, to identify the risk of a patient developing lupus.
PredictImmune's test relies on a 16-marker panel run using quantitative PCR to stratify Crohn's disease and ulcerative colitis patients according to the severity of their illnesses.
The assay is for diagnosing lupus and is the second immunofluorescence assay cleared by the FDA for the Helios platform.
The firm's CEO said that the test must undergo additional clinical studies, but it could be available from a CLIA-certified lab in about a year and a half.
The researchers won a $386,599 NIH grant to evaluate the usefulness of measuring known markers of the disease in saliva and to identify potential new markers.
The partners will use Immunovia's antibody array platform for the discovery of diagnostic biomarkers associated with four autoimmune diseases.
Bio-Rad said that the Visia platform offers a standardized and automated workflow needed by laboratories to handle ever-increasing immunofluorescence workloads.
Kindstar has been granted exclusive rights to market the SLE-Key Rule-Out test in China, which will be the initial product offering stemming from the partnership.
Quanterix's Simoa single-molecule detection method combined with high-affinity antibodies detected minute levels of problematic interferon alpha proteins, a study said.