By Fineline Cube 
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its cobas liat system-based point‑of‑care test for whooping cough (pertussis) and other Bordetella infections has received FDA 510(k) clearance, CLIA waiver, and CE IVDR certification.
Regulatory & Commercial Milestones
| Approval/Certification | Significance |
|---|---|
| FDA 510(k) Clearance | Market authorization for US commercialization |
| CLIA Waiver | Enables use in non‑laboratory settings (GP practices, Emergency Rooms) |
| CE IVDR Certification | Compliance for European market entry |
| Total Time to Market | From development to full regulatory approval in 15 months |
Technology & Performance Specifications
- Platform: cobas liat system (point‑of‑care PCR)
- Turnaround Time: 15 minutes from sample to result
- Pathogen Coverage: Detects and differentiates three Bordetella species causing cough symptoms
- Clinical Setting: Designed for GP practices and Emergency Rooms
- Actionability: Enables physicians to prescribe appropriate antibiotics during initial consultation
Clinical & Strategic Impact
| Clinical Benefit | Mechanism |
|---|---|
| Immediate Diagnosis | Results available during patient consultation |
| Rapid Treatment | Antibiotics administered within the diagnostic window |
| Complication Prevention | Early intervention reduces risk of severe pertussis outcomes |
| Transmission Control | Prompt identification limits community spread |
| Differential Diagnosis | Distinguishes Bordetella species for targeted therapy |
Market Context & Commercial Opportunity
- Whooping Cough Burden: US sees 10,000‑50,000 cases annually; resurgence due to vaccine waning immunity
- Point‑of‑Care Gap: No existing 15‑minute PCR test for pertussis in primary care settings
- Revenue Potential: Roche projects $150‑200 million peak US sales from cobas liat respiratory portfolio
- Competitive Moat: First‑mover advantage in rapid pertussis diagnostics; strengthens cobas liat platform ecosystem
- Global Rollout: CE mark enables EU launch in Q1 2026; Asia‑Pacific regulatory filings planned for 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for the whooping cough test. Actual results may differ due to regulatory, competitive, and adoption uncertainties.-Fineline Info & Tech