Industrial Technology Research Institute

Technology Overview

Clinicians often encounter tumors that do not respond well to standard treatments. To address this, they use liquid biopsies to detect biomarkers in a patient's blood and urine for cancer diagnosis and monitoring. This method helps determine better medications and tracks disease recurrence in later stages, offering a more effective approach to treatment.

ITRI has developed the Multiple Circulating Molecule Preparation and Detection Technology, providing a one-stop solution for liquid biopsy testing. This includes three key steps: stable preservation, extraction and purification, and molecular detection. The team has created a special formula that can preserve whole blood at room temperature for 14 days while maintaining molecular stability. Through an extraction and purification reagent kit, it can simultaneously obtain nucleic acid targets such as circulating free nucleic acids and exosomes. Compared to leading international products, this technology reduces operation time by half and increases detection sensitivity by more than tenfold.

In the future, this technology can be applied to colorectal cancer, lung cancer, breast cancer, and other diseases for dynamic monitoring such as disease risk assessment and adjunctive therapy. It helps physicians evaluate targeted drug options, potentially reducing patient pain and extending life.

Features & Specifications

• The blood collection formula developed in this technology stabilizes multiple circulating nucleic acids in the blood, ensuring their stability when stored at room temperature.
• Multiple circulating nucleic acid isolation and purification reagents: Affinity materials have been developed targeting the negatively charged properties of circulating cell-free nucleic acids and extracellular vesicle nucleic acids in plasma. These materials enable simultaneous separation and purification of both types of nucleic acids in a single step, simplifying the detection process and reducing time. Subsequently, multiple circulating nucleic acid molecular testing can be conducted, aiming to enhance the sensitivity and specificity of gene mutation detection, providing more precise drug treatment judgments.
• The colorectal cancer KRAS and BRAF detection assay is a molecular qualitative assay kit based on qPCR technology. It detects whether colorectal cancer patients have KRAS or BRAF mutations, serving as a basis for pre-targeted drug diagnosis. Compared to currently available products, it offers higher detection sensitivity (0.1-0.5% VAF) and specificity, capable of detecting trace variants in high-background samples, and applicable to tissue sections (FFPE) and liquid biopsy testing. Currently available qPCR-based assays do not simultaneously detect KRAS and BRAF genes. This detection technology reduces clinical sample usage, reagent, and labor costs, while obtaining more sample information. Additionally, this molecular detection technology can be integrated into LDT services. This assay kit can effectively detect somatic mutations in KRAS gene Exon 2-3: G12C, G12D, G12V, G12A, G12S, G12R, G13D, Q61H, Q61R, Q61K, Q61E, Q61P, Q61L, as well as BRAF gene variants: V600E, V600D, V600G, V600A, V600M, V600R, V600K, and V600_K601delinsE.

Applications & Benefits

1. Targeted vendors eligible for independent licensing: channels with existing sales or relevant products.
2. Service-oriented detection model, linking with medical institutions for service contracts and simultaneous product supply chain.
3. A comprehensive suite of internally developed liquid biopsy technologies: blood preservation formula, cell-free nucleic acid extraction and purification kit. These aid in translating laboratory research (RUO) into LDT services, integrating precision medicine molecular testing LDT service operations, accelerating the commercialization process and benefits.

One-Stop Biomedical Services

• Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
• Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, and targeted drug and delivery technology.
• Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
• Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, and clinical trial analysis and reports.
• Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical document preparation, business ecosystem linkage, and more.