PathoScan hrHPV qPCR Kit

Nusantics (PT Riset Nusantara Genetika) is an Indonesian precision molecular diagnostics company based at the i3L campus in Pulomas, East Jakarta, working with PCR and next-generation sequencing. It develops locally made test kits to make screening more affordable, including for cervical cancer, the second most common cancer among Indonesian women.

PathoScan hrHPV is a real-time PCR kit that detects 14 high-risk HPV types, genotyping HPV16, HPV18 and HPV52, using the proprietary Fenrir Mastermix with probes targeting the E6 and E7 genes and beta-globin as internal control. It accepts DNA from cervical swabs or first-void urine, runs in under 35 minutes and is an open system compatible with QuantStudio 5, Bio-Rad CFX, Rotor-Gene Q and Gentier 96E instruments. A Lite version genotypes HPV16 and HPV18. Users are clinical laboratories and hospitals.

• 14 high-risk types: detects HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
• Partial genotyping: separate reporting of HPV16, HPV18 and HPV52.
• Dual sample types: validated for cervical swabs and first-void urine.
• Fast run: PCR completes in under 35 minutes.
• Open system: works on common qPCR instruments with FAM, HEX, Texas Red, Cy5 and Cy5.5 channels.
• Internal control: beta-globin control to verify sample quality.

Private laboratory chains in Vietnam could add urine-based HPV testing to women's health packages. Obstetrics and gynaecology hospitals could run the kit on existing qPCR machines for screening programmes. Diagnostic distributors could partner to register and supply the kit for provincial screening campaigns.

Urine sampling offers a painless alternative to cervical swabs, which can raise screening participation. Published figures on the product page show 96.55% sensitivity and 99.87% specificity on cervical swabs, and 98.48% accuracy on urine. The open-system, ready-mix format lets laboratories use their existing qPCR machines with a short run time. The kit is registered with Indonesia's Ministry of Health and is available through the government e-catalogue.

WHO's cervical cancer elimination strategy is pushing countries to switch from cytology to HPV DNA testing, and Indonesia has a national action plan for 2023 to 2030. Self-collected and urine-based sampling, plus lower-cost regional kits, are seen as ways to reach women who avoid clinic-based screening.

Legal entity PT Riset Nusantara Genetika, also operating PT Nusantara Butuh Diagnostik, based at i3L Campus, Pulomas, East Jakarta. Registered with Indonesia's Ministry of Health (AKD 20306320321). Distributed by PT Biogen Scientific Indonesia, with Diagnos Laboratorium as urine HPV testing partner. Partner logos include East Ventures, Illumina, Bio Farma and RSCM.