Redefining the Boundaries of Companion Diagnostics
No single biomarker detection technology can cover the entire chain of CDx development needs — from rapid screening to deep molecular characterization. The optimal approach is to select the most appropriate technology platform or combination based on specific clinical scenarios and testing objectives.
Novobay's dual-platform architecture is purpose-built to address this reality, combining the speed and accessibility of PCR POCT with the depth and versatility of nanopore sequencing.
Rapid, automated molecular testing at the point of care. Same-day results with minimal sample requirements.
Long-read sequencing for comprehensive molecular profiling. Direct RNA sequencing, structural variation, and methylation detection in a single run.
Systematic solution to all five challenges in companion diagnostics development
Single-section sufficiency
3–4 hours vs. 2 weeks
Unified quality management
Screening to deep profiling
No specialized lab needed
NGS failure rate 20–40% on FFPE samples; micro-lesion DNA often <1ng. Our PCR POCT platform requires only a single FFPE section, dramatically reducing sample requirements.
Traditional NGS requires 2 weeks; multi-center trial wait times vary widely. Our PCR POCT delivers results in 3–4 hours, enabling same-day clinical decisions.
Different centers and platforms produce incomparable results; no unified reference standard. Our dual-platform enables unified quality management across all sites.
Single technology cannot cover the full spectrum from screening to deep profiling. Our dual-platform covers all scenarios — rapid screening to comprehensive molecular characterization.
Requires specialized labs and skilled personnel; weak infrastructure in developing regions. Our PCR POCT requires no specialized laboratory — deploy anywhere.
| Technology | Turnaround | Sample Req. | Lab Required | Hotspot | Fusion | Methylation | SV Detection |
|---|---|---|---|---|---|---|---|
| PCR POCT (Novobay) | 3–4 hrs | 1 FFPE section | ✗ | ✓ | ✓ | — | — |
| Nanopore (Novobay) | Same-day | Low input | Optional | ✓ | ✓ | ✓ | ✓ |
| Manual IHC | 2–5 days | Tissue | ✓ | ✓ | — | — | — |
| FISH | 3–7 days | Tissue | ✓ | ✓ | ✓ | — | — |
| Short-Read NGS | 7–14 days | High | ✓ | ✓ | Partial | Partial | — |
* SV = Structural Variation. Data from internal validation studies. Subject to regulatory approval status.
Dive deep into each platform's capabilities, validation data, and ideal use cases.