Package-Ref™ MRD Cocktail Reference Standard

Description

MRD refers to tumor cells or markers that remain in the body after treatment. There are three common translations: Minimal Residual Disease, Measurable Residual Disease, and Molecular Residual Disease.

After radical treatment, tumor patients still have residual tumor cells in their bodies, which is an important cause of recurrence and metastasis. Molecular abnormalities that cannot be found by traditional imaging or experimental methods but can be found by liquid biopsy can provide important reference for clinical treatment decisions.

General Information

MRD Detection Technology

There are two main technical routes for MRD detection of ctDNA: tumor-agnostic assays and tumor-informed assays. Tumor-agnostic assays only detect plasma and use fixed panels (generally driver genes and targeted drug genes, and multi-omics methods) and analytical methods to detect and analyze ctDNA.

Tumor-informed assays require sequencing of primary tumor tissue (usually WES) to identify the patient's specific genomic variation profile, and then customize a personalized panel to test ctDNA, which means that both tissue and plasma need to be tested.

One of the most difficult aspects of MRD technology is the ability and stability to detect ultra-low frequency mutations. Taking non-small cell lung cancer as an example, the median cfDNA concentration in the plasma of early NSCLC patients is 7.69 ng/mL, which is equivalent to about 20,000 haploid genomes (3.3pg) in 10 mL of plasma (20ml of whole blood). Considering the loss of cfDNA during library construction and the presence of at least two identical variant gene sequences, the limit molecular signal detected by ctDNA in 10 mL of plasma is 0.02%. In addition, according to the TRACERx research data, in the case of a tumor volume of 1 cm3, 10 mL of plasma contains about 2 tumor-derived DNA molecules. Therefore, when performing MRD detection in NSCLC, the detection method must be able to stably detect ctDNA with an abundance of ≥ 0.02%. There is an important technical strategy here, which is the Sample Level strategy. For Site level of 0.02% or even lower, the sensitivity can be improved through Samples Level.

Detailed Data

The development of MRD diagnostic IVD for ctDNA detection requires performance evaluation, and naturally the development of standard products. Kebai Gene is a research and development and production company focusing on diagnostic positive reference products, detection limit reference products, and precision reference products in IVD research and development. For the development of ultra-low frequency standards for ctDNA, we launched our MRD standard: Package-RefTM MRD Cocktail Reference Standard.

Dilution Multiple Verification Data

This is a multi-gene, multi-site panel standard with a wide range of gene and site coverage and rich mutation types. It is very suitable as a reference and quality control product for LDT and IVD testing.

Product application

1.Performance verification for pan-tumor MRD ctDNA detection

2.For routine quality control of pan-tumor MRD ctDNA detection