Fully Automated Molecular Diagnostics for Precision Medicine
Redefining molecular diagnostics with fully automated, rapid, and accessible solutions for clinical settings worldwide.
Technical Specifications
| Parameter | Specification |
|---|---|
| Detection Time | 30 min – 4 hours (FFPE as fast as 3 hours) |
| Sample Requirement | Single 5μm FFPE section (<1ng DNA still detectable) |
| Operation Mode | Fully automated "Sample In – Result Out" |
| Throughput | 6 independent channels, random access |
| Regulatory Status | NMPA Class III Medical Device (Registered July 2023) |
| Detection Coverage | EGFR, ALK, ROS1, BRAF, KRAS, RET, MET and other key oncology drivers |
| Automation Level | No biosafety cabinet, no pipetting, no specialized lab required |
| Sample Types | FFPE, Fresh tissue, Pleural/pericardial effusion, Frozen tissue, Swabs |
Clinical Validation
Ability to correctly identify positive samples
Ability to correctly identify negative samples
Validated vs. NGS and RT-PCR reference
Overall agreement with reference methods
Concordance rate vs. NGS/RT-PCR
Positive predictive value of test results
Concordance with confirmed diagnoses
Clinical Validation Protocol: All clinical validation data were generated through multi-center studies with institutional IRB approval. Sensitivity and specificity were calculated against parallel testing using approved NGS panels and RT-PCR as reference methods.
Core Advantages
Complete "Sample In – Result Out" workflow. No biosafety cabinet, no pipetting, no specialized laboratory required. Eliminates human error and operator variance entirely.
Results in 30 minutes to 4 hours depending on sample type. FFPE samples processed in as little as 3 hours. Enables same-day enrollment decisions for clinical trials.
Single 5μm FFPE section is sufficient. DNA content as low as <1ng still delivers reliable results. Maximizes utilization of scarce biopsy samples.
Optimized for formalin-fixed paraffin-embedded (FFPE) tissue samples — the gold standard for clinical pathology. Perfectly handles archived samples that fail NGS in 20–40% of cases.
Registered as a Class III Medical Device with NMPA (July 2023), enabling broad clinical deployment. Ideal for POCT scenarios, emergency departments, community hospitals, and resource-limited settings.
Workflow
FFPE / Tissue / Pleural fluid
~5 min
Fully automated nucleic acid purification
~30 min
Real-time fluorescent PCR detection
~1–2 hours
Intelligent result interpretation
Automatic
Actionable clinical report generated
Immediate
Note: Total turnaround time varies by sample type (30 min – 4 hours). FFPE samples typically complete within 3 hours. 6 independent channels allow random-access testing of multiple samples or gene panels simultaneously.
Applications
Rapidly screen patients for trial eligibility. Supports "fast-fail" strategy to reduce sunk costs. Get enrollment decisions in hours, not weeks.
Supports companion diagnostics registration with NMPA/FDA regulatory pathways. Aligns with global CDx development standards for targeted therapy.
Comprehensive driver gene detection across lung cancer and other solid tumors. Guide precise medication selection for targeted therapies.
No specialized laboratory needed. Ideal for community hospitals, primary care clinics, and resource-limited settings where molecular testing was previously impossible.
Standardized automated workflow ensures data comparability across sites. Eliminate inter-site variability in clinical studies.
Supports diverse sample types: FFPE tissue, fresh tissue, pleural/pericardial effusion, frozen sections, and clinical swabs — maximizing patient enrollment.
Gene Coverage
Corresponding drugs: Osimertinib, Alectinib, Brigatinib, Pralsetinib, etc.
Corresponding drugs: Cetuximab, Sotorasib, Encorafenib, etc.
Corresponding drugs: Selpercatinib, Pralsetinib, Dabrafenib+Trametinib, etc.
Corresponding drugs: Olaparib, Erlotinib, etc.
Corresponding drugs: Trastuzumab, Olaparib, Alpelisib, etc.
Corresponding drugs: Imatinib, Midostaurin, Ivosidenib, etc.
Dual-Platform Synergy
Fast, automated screening for known mutations and fusion genes. 3–4 hour turnaround enables same-day decisions.
Long-read sequencing for structural variants, RNA quantification, methylation analysis, and comprehensive molecular profiling.
The dual-platform approach transforms companion diagnostics from sequential single-gene testing into a comprehensive molecular profiling workflow. Use PCR POCT for rapid enrollment screening and Nanopore for deep molecular characterization — covering the full spectrum from known biomarker detection to novel biomarker discovery.
Learn About Nanopore Platform →Contact us to discuss collaboration opportunities, technical profiles, or clinical partnership.
Email: inquiry@novobaybio.com