Finding reliable biomarkers is the key to shortening the screening window for new drugs and improving the success rate of clinical trials. HST GENOMICS integrates genome resequencing, epigenetic status and mass spectrometry highly sensitive proteomics technology to help pharmaceutical companies capture specific response-related genes in complex clinical cohorts.
1. Full spectrum candidate screening: Based on unbiased DIA mass spectrometry proteome or WGS chip, the molecular background characteristics of different pharmacodynamic response groups are systematically established.
2. Feature algorithm identification: Introducing machine learning multiple co-expression networks to filter gene background redundancy and accurately target highly specific candidate markers.
3. Targeted reagent development: For the selected Marker, perform rapid conversion and customization of KASP primers or targeting chips.
Biomarker screening delivers marker heatmaps, PCA models, differential abundances, and ROC prediction curves based on multidimensional omics algorithms.
| analysis stage | Deliver data and charts | core value |
|---|---|---|
| Early unbiased screening | Differential protein/mutation site heat map, principal component analysis (PCA) scatter plot | Identification of significant molecular differences between the control group and the drug-responsive group |
| Machine learning dimensionality reduction screening | LASSO feature regression curve, random forest importance ranking chart | Refine minimal marker signature panels from thousands of candidate molecules |
| Marker performance assessment | ROC prediction performance curve (AUC value calculation) | Evaluate the accuracy of markers in predicting drug efficacy/toxicity and side effects |
Biomarker screening requires high-quality and high-purity samples as input for algorithm analysis. The recommended sample delivery standards are as follows:
| Sample type | Minimum sample size | Quality control standards | Shipping/storage recommendations |
|---|---|---|---|
| Clinical fresh frozen tissue | > 50 mg | Necrosis rate < 10%, tumor cell purity > 50% | Quick-frozen in liquid nitrogen, stored at -80°C, and transported on dry ice |
| EDTA anticoagulated whole blood | 5 - 10 mL | Extraction using dedicated cfDNA/RNA antiseptic tubes | Cold chain transportation at room temperature or 4℃ to avoid freezing |
| plasma/serum | > 1 mL | Hemolysis is strictly prohibited and high-speed centrifugation is required to remove cell debris. | Store frozen in sterile centrifuge tubes and ship on dry ice |
Data compliance in Phase II and Phase III clinical development directly determines the possibility of approval of a New Drug Application (NDA). HST GENOMICS has established a medical reference laboratory in the Shenzhen Medical Center that is fully compliant with CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments) certification to ensure that the entire trial follows the highest level of quality control system.
1. Incoming component sieving (Stratification): Identify patient genotypes through rapid PCR or sequencing to assist in precise enrollment screening of targeted markers.
2. Toxicology and Safety Monitoring (PGx): Monitor polymorphisms of multiple cytochrome P450 enzymes (e.g., CYP2D6, CYP2C19) to prevent drug accumulation and toxicity.
3. Minimal Residue Monitoring (MRD) and Efficacy Tracking: For oncology drugs, ultra-sensitive ctDNA deep-read sequencing is provided to evaluate molecular-level drug efficacy.
Provide test reports and drug efficacy index evaluation data that meet CAP/CLIA dual certification standards and are clinically mutually recognized by FDA/NMPA.
| Certification and testing specifications | Statement of Conformity and Service Indicators |
|---|---|
| CAP Accredited | Fully CAP accredited Molecular Pathology, NGS Proficiency Test (PT) |
| CLIA Certified | High-standard clinical sequencing, the original test report is mutually recognized by the FDA and international multi-drug regulatory systems |
| Pharmacogenomics (PGx) | Based on PharmGKB standards, covering 30+ core drug metabolism genes |
| Ultra-sensitive ctDNA detection | LOB/LOD verification limit of 0.01%, equipped with molecular tag (UMI) dual background denoising |
In order to ensure timeliness and compliance, please refer to the following standards when submitting samples for clinical trials:
| Inspection items | Sample specifications | Sampling tube specifications | Time in Transportation and Turnaround (TAT) |
|---|---|---|---|
| Enrollment genotyping (blood) | 5 mL peripheral blood | Streck / Streck-like cfDNA anti-corrosion tubes | Shipping at 4℃, delivery within 48 hours, delivery within 3-5 working days |
| MRD dynamic monitoring (blood) | 10 mL peripheral blood | Special ctDNA storage tube (anti-rupture, anti-lysis) | Room temperature shipping, delivery within 4 working days |
| Histomolecular Pathology (FFPE) | 8-10 paraffin sections | Slide damage-proof box, light-proof packaging | Shipping at room temperature or cold pack, delivered within 7 working days |
Companion diagnostics (CDx) are a dual-track pillar for the successful commercialization of new precision oncology drugs. As an upstream company with chip and liquid processing hardware development capabilities, HST GENOMICS can provide pharmaceutical companies with full-process CDMO services from biomarker to registration-level in vitro diagnostic (IVD) kit development.
1. joint verification: Simultaneous entry into the design and process verification of companion diagnostic molecular probes during the first and second phases of new drugs.
2. Reagent transformation and production: Pilot and mass production of customized multiplex PCR or hybridization capture sequencing kits in a 100,000-level dust-free workshop that complies with GMP standards.
3. Joint declaration: Assist pharmaceutical companies in organizing design history files (DHF) to support National Food and Drug Administration (FDA/NMPA) approval applications for simultaneous companion diagnostics.
Provide CDMO customized kit design, pilot and mass production delivery packages that are fully compliant with GMP specifications.
| Development and production categories | Main technical routes | Compliance with the quality specification system |
|---|---|---|
| Companion Diagnostics (CDx) Kits | Multiplex real-time PCR/NGS hybridization capture enrichment | GMP 100,000 level purification workshop, ISO 13485 quality management system certification |
| Liquid biopsy testing reagents | Magnetic bead nucleic acid extraction and micro-homogeneous amplification system | High-precision automated liquid packaging and stock solution freeze-drying process |
| Declaration Compliance File (DHF) | Detection precision, sensitivity, specificity and stability data documentation | Assist pharmaceutical companies to simultaneously apply for FDA (PMA) or NMPA (Class III medical devices) |
Since CDMO and companion diagnostic development involve highly customized commercial compliance services, ordinary scientific research samples are not accepted. The cooperation and material docking process is as follows:
1. The first technical exchange: Please provide the mechanism of action, target sequence and expected analytical performance limit requirements (LOD) of the new drug.
2. Verification reference materials provided: When verifying the performance of the kit, both parties need to jointly provide plasmids, cell lines or clinical pathology samples containing the target mutation (desensitization is required, and gold standard Sanger sequencing or qPCR verification results are required).
3. Transportation specifications: Standard control cell lines or frozen DNA/RNA need to be transported sealed with dry ice and strictly transferred at 4℃ or -20℃.