DIACARTA

Company Overview

DiaCarta Inc. is focused on developing and commercializing molecular diagnostics, offering various services, such as testing through its CLIA-certified lab, next-generation sequencing (NGS), companion diagnostics, and CAR-T immunotherapy. The company’s diagnostic assays are primarily designed to work with formalin-fixed, paraffin-embedded (FFPE) tissue, but it is increasingly shifting toward liquid biopsy tests. One of its key offerings, the ColoScape test, utilizes QClamp XNA-based clamping technology and real-time PCR analysis to screen for 20 colorectal cancer mutations. Introduced in 2018, the test is now available in a liquid biopsy format, using samples from FFPE, stool, or blood, offering a faster turnaround time of under three days compared to competitors like Cologuard, which requires human stool and has a two-week turnaround.

ColoScape is primarily used for triage purposes, helping identify patients with positive fecal hemoglobin tests who need a colonoscopy and for recurrence monitoring. In addition to ColoScape, DiaCarta is developing other liquid biopsy tests to detect mutations in genes like EGFR, BRAF, and PIK3CA. The company also operates a CLIA laboratory offering OptiSeq, a pan-cancer liquid biopsy test that uses NGS to analyze 2,900 hotspots across 65 oncogenes and tumor suppressor genes.

Company's Business Segments

• Products : Diacarta generates revenue from products in Oncology, Infectious Diseases, OTC/POC Tests and Accessories, Research Use Products, Consumables.
• Clinical Services : Cancer Progression and Therapy Response Monitoring, Colorectal Cancer, Bladder Cancer, Urinary Tract Infection (UTI), In Vitro Fertilization (IVF), Infectious Diseases.