Onclarity™ HPV Assay — Extended Genotyping

Onclarity™ is the only HPV assay that provides extended genotyping for all 14 high-risk types in a single test run. Primers and probes are designed to target the HPV E6/E7 oncogene region — the most clinically significant region for cancer risk assessment — significantly improving viral detection sensitivity and reducing the risk of missed detection due to nucleic acid deletions or mutations.

The assay uses 15 different probes, each labelled with one of four fluorescent dyes, preventing suppression of low-concentration targets by high-concentration targets in mixed infections. Cross-reactivity testing has confirmed no interference with multiple bacteria, fungi, viruses or low-risk HPV types. Common vaginal interfering substances (medications, lubricants, hormones, blood) do not affect results.

Viper LT™ — Fully Automated Molecular Platform

• Automated sample tube piercing — no manual uncapping or transfer
• Ready-to-use reagent cartridges — minimal hands-on time
• Continuous loading — no batch scheduling required
• Integrated DNA extraction, RT-PCR amplification and result reporting
• Compact benchtop footprint — suitable for labs of all sizes

FDA Clinical Evidence (PMA Study)

• Prospective screening study including healthy (non-referral) populations
• Standardised disease confirmation protocol with colposcopy at final year
• 3-year longitudinal follow-up of ~8,900 subjects
• >500 million data points submitted — largest IVD clinical trial in FDA history
• Meets all criteria of international HPV IVD clinical performance guidelines