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A new study aims to compare the detection performance of Helio Health's circulating tumor DNA assay with that of other screening modalities.
Created by BloodPAC members, the resource may serve as a set of generic analytical protocols to help define industry standards for developing liquid biopsy tests.
The gene expression test retrospectively identified rheumatoid arthritis patients significantly less likely to respond to TNF inhibitor therapy.
The company began offering testing to clinicians in the first quarter of this year and expects volume to grow significantly over the next several months.
The study will recruit up to 200 patients with active Crohn's disease or ulcerative colitis and sort them into high- and low-risk cohorts using the PredictSure IBD test.
The validation of its current CLIA testing comes as Biocept is in the early stages of expanding to provide kit versions of its liquid biopsy tests.
Called the "Ccheck Prostate Cancer Confirmation" test, Anixa's assay integrates flow cytometry and machine learning to identify evidence of cancer in a person's bloodstream.
Investigators concluded that the spiked samples from SeraCare were a robust tool for inter-lab comparisons and discussed some areas of discordance seen in the study.
The company is seeking NY State approval for its lab, which would allow it to offer both tests as LDTs, hopefully by the end of this year or early next.
Based on the results, the UAE-based lab would become Biocept's first customer to use the kits clinically, accepting samples from the Middle East, Africa, and Asia.