What are molecular diagnostic standards?

1. IVD product development

· Performance verification: verify the sensitivity and specificity of the test kit;

· Registration application: submit cross-reaction data of standards.

2. Clinical laboratory quality control

· Daily quality control: monitor PCR amplification efficiency and NGS sequencing depth uniformity;

· Inter-laboratory comparison: transfer the value through standards to achieve mutual recognition of multi-laboratory results.

3. Companion diagnostic development

· Companion diagnostic reagent matching: provide specific mutation standards to ensure the accuracy of drug efficacy prediction;

· Drug resistance mechanism research: build a drug resistance gene mutation standard library.

Ⅰ. Upstream of IVD industry chain: "ruler" of instrument and raw material manufacturing

1. Customer group: instrument equipment manufacturers (NGS/qPCR/ddPCR platform)

Demand scenario:

· New equipment performance verification (sensitivity/specificity/repeatability test);

· Multi-platform test result consistency calibration.

Standard selection:

· Cross-platform compatible standards (such as universal DNA quantitative standards);

· Extreme sample simulation products (high GC content, fragmented DNA).

2. Customer group: core raw material supplier (enzyme, primer, probe)

Demand scenario:

· Raw material batch quality control (such as Taq enzyme activity verification);

· Competitive product performance benchmarking (testing raw material sensitivity differences through standard products).

Standard selection:

· Simulated samples containing inhibitors (verification of anti-interference ability);

· Low-concentration target standards (detection of raw material extreme sensitivity).

Ⅱ. IVD midstream industry chain: "navigator" for kit development

1. Customer group: IVD kit R&D companies

Demand scenarios:

· R&D stage: target screening and verification (such as new mutation site coverage test);

· Performance optimization: sensitivity/specificity verification (LoD/LoQ determination);

· Registration application: provide third-party traceable data, such as standard product sets with supporting certificates of analysis (COA);

· Production quality inspection: batch release testing, such as internal reference gene standards.

Standard product selection:

· Multiplex PCR/NGS Panel verification standards;

· Complex matrix standards (such as ctDNA simulations in plasma).

2. Reference panel (Panel) developer

Demand scenarios:

· Cross-reaction verification of multi-target joint detection kits;

· Development of clinical sample substitutes (such as FFPE simulation samples).

Standard product selection:

· Multiplex PCR/NGS Panel verification standards;

· Complex matrix standards (such as ctDNA simulations in plasma).

Ⅲ. Downstream of IVD Industry Chain: "Guardian" of Clinical Application and Quality Control

1. Customer Group: Pharmaceutical Companies (Development of Companion Diagnostics)

Demand Scenarios:

· Drug-biomarker matching verification;

· Dynamic monitoring of drug-resistant mutations.

Core Demands:

· Standard products developed simultaneously with CDx kits;

· Companion diagnostic clinical trial sample equivalents.

2. Third-party testing agencies (LDT/medical testing institutes)

Demand Scenarios:

· Daily quality control: intra-batch/inter-batch precision monitoring;

· Inter-laboratory quality assessment (EQA): comparison of consistency of results between laboratories;

· Detection limit verification: LoD confirmation.

3. Hospital Laboratory/Pathology Department

Demand Scenarios:

· Verification of new testing projects (such as in-hospital verification of tumor NGS Panel);

· Traceability and interpretation of report results.

Pain Point Solutions:

· Ready-to-use pre-packaged standard products (reduce operational complexity);

· Quick interpretation guide (such as Ct value/mutation frequency interpretation threshold).