LabGenomics Enters US Cancer Diagnosis Market... "100% Subsidiary Clia Lab Introduces 3 Types of NGS Cancer Diagnostics"
LabGenomics announced on the 24th that it has completed the development of cancer diagnostic NGS (Next-Generation Sequencing) services and will introduce them to its 100% US subsidiary, CliaLab QDx (QDx Pathology Services). The services being introduced include three types: the ‘BRCA1/BRCA2 panel test,’ the ‘Comprehensive Hereditary Cancer Panel test,’ and the ‘OTD-Solid (OmniTumorDetect-Solid) solid tumor panel test.’
These three cancer diagnostic services can be directly introduced to QDx as LDTs (Laboratory Developed Tests) without going through the FDA (Food and Drug Administration) track. First, the ‘BRCA1/BRCA2 panel analysis’ service evaluates the genetic risk of breast and ovarian cancers. The ‘Comprehensive Hereditary Cancer Panel analysis’ service assesses genetic risks for various types of hereditary cancers all at once. The ‘OTD-Solid panel analysis’ service is used for the diagnosis and treatment selection of various solid tumors such as colorectal cancer, lung cancer, liver cancer, and breast cancer.
The performance of all panel analysis services has been significantly improved, and profitability is expected to increase due to successful cost reduction. In particular, the BRCA1/BRCA2 analysis boasts a high accuracy with a 0% retest rate. Additionally, the average turnaround time (TAT) for the solid tumor analysis service has been shortened from 3 weeks to 2 weeks, providing faster results to medical staff and enabling prompt treatment for patients. The company explained that the technology collaboration with EnGenBio played a major role in building this portfolio.
Mi-jin Oh, Executive Director of LabGenomics and head of the research institute, said, “We have been able to provide an upgraded NGS diagnostic service to QDx,” adding, “We will continue to develop NGS tests in line with the US cancer conquest policy.”
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She continued, “During a recent business trip to the US, executives including Dr. Qureshi, the founder of QDx, were very positive about Korea’s advanced diagnostic technology,” emphasizing, “This will accelerate our R&D activities and increase interest in our NGS services linked to the US cancer conquest project, ‘Cancer Moonshot.’”
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