IVD Companion Diagnostics
One of two flagship reference programs. Built on the Apollo Hospitals biobank, orchestrated through LabOS, and packaged for CDSCO + FDA bridging via ClinicalBridge. For the full pharma R&D lifecycle, see Pharma R&D.
The customer scenario
A pharma partner has a Phase 2 oncology drug — say, a targeted therapy in NSCLC or HER2-low breast cancer. To enter Phase 3 with a stratified label, they need a regulator-grade companion diagnostic (CDx) that predicts responders. Traditional path: outsource to Roche Dx or Thermo Fisher — 4–6 years, $30–50M, parallel to clinical development, and almost always FDA-optimized with CDSCO as an afterthought.
Program timeline
| Phase | Months | LabOS execution | Cost |
|---|---|---|---|
| Biomarker discovery | 0–3 | OmicsOS Hypothesis Agent over Apollo NSCLC cohort (scRNA + WGS + IHC) + literature. Ranked candidate biomarkers with uncertainty. | $0.4M |
| Analytical validation | 3–9 | Design Agent emits typed DAGs; Execution Broker routes to Syngene (assay dev), MedGenome (NGS validation). Precision, accuracy, LoD/LoQ per CLSI EP05/EP17. | $1.6M |
| Clinical validation | 9–15 | Retrospective Apollo cohort (consented, IRB-approved) + prospective sub-study. QC Agent enforces sample-quality gates. Provenance-signed graph for every datapoint. | $2.5M |
| Regulatory submission | 15–18 | ClinicalBridge packages CDSCO IVD dossier + FDA pre-submission Q-Sub. Cross-agency bridging strategy. | $0.5M |
| Total | 18 months | vs. 4–6 years traditional | $5.0M vs. $30–50M |
Regulatory pathway
CDSCO-first (India launch)
IVD dossier under New Medical Devices Rules 2017. Apollo investigator-initiated extension for clinical validation. Typical review 6–9 months post-submission.
FDA bridging (global label)
Q-Sub pre-submission leveraging Apollo retrospective cohort + analytical validation data. MiRXES/BioHelix path for APAC manufacturing if kit production scales. See Singapore BioHelix.
Revenue to us
- $1.5M upfront sprint fee (LabOS + sample analysis + analytical validation)
- $500K × 3 milestones (analytical lock, clinical lock, regulatory acceptance) = $1.5M
- $5–10/test royalty on Dx kit sales (at peak 50K–200K tests/yr → $0.25–2M/yr recurring)
- 5–10% royalty on the drug’s CDx-stratified clinical revenue (long-tail, decade+)
- Apollo revenue share: 25–35% of kit royalty + Atlas licensing uplift
Why this works for the pharma buyer
- 6× faster, 6–10× cheaper than the Roche Dx route
- India-first regulatory path de-risks domestic launch; FDA bridging via Q-Sub strategy
- Auditable provenance — every datapoint signed to its DAG; reviewer can replay
- Apollo clinical credibility on the submission — investigator-initiated extension built in
- Companion Dx ready for Phase 3 enrollment stratification, accelerating clinical timeline
Engagement terms
$5M total over 18 months, milestone-gated. Exit at analytical lock, clinical lock, or regulatory acceptance. Co-development option for kit commercialization. Contact skannan@oncophenomics.com for program scoping.