A multiplex-PCR HPV self-collect test for genotypes 16, 18 and 45 — manufactured by eDNA Teknoloji (Türkiye) under the genoma brand — designed for women who can't or won't visit a clinic for a Pap smear.
CarciScan removes the two biggest barriers to cervical screening: a clinic visit and a speculum exam.
The self-collection kit ships directly, with plain-language instructions.
A private vaginal swab, done at home in under two minutes — no clinician required.
The sample is processed for high-risk HPV genotypes 16, 18 and 45 in a certified lab.
Positive results are paired with a clear referral pathway into the clinical system.
We link every claim to its source and state plainly what each study does and doesn't prove.
Dillner et al., medRxiv, 4 Feb 2026. A 10-country, 13-assay collaborative evaluation; a Turkish reference lab used CarciScan as its assay. Pooled sensitivity 90.08% / specificity 92% across all assays tested.
Taumberger et al., Cancer Control (SAGE), 2025. Published protocol for an n=1,000 CarciScan-based screening study.
Letter dated 6 Jul 2026 supporting a Philippines pilot / proof-of-concept deployment, from a co-author on the Karolinska/WHO evaluation.
Early analytical/target-detection testing showed 95% sensitivity / 100% specificity.
Turkey's national screening program has tested roughly 4.1 million women using HPV DNA methods generally. This demonstrates that population-scale HPV self/self-collect screening is operationally viable in a comparable health system.
Certified under the legacy EU IVDD (98/79/EC) framework, dated 2022.
Quality management certification on file, valid through 09 May 2024.
Registered as IVD-Other in Turkey's ÜTS device registry, with a stated future commitment to pursue IVDR Class C.
Per FDA/CDRRHR guidance (Circular 2020-001, letter dated 6 Jul 2026), HPV in-vitro diagnostic devices of this class are non-registrable with the Philippine FDA — no product approval is required. The operative requirement is a License to Operate (LTO) as a medical-device establishment, needed for import and public-sector bidding.
CarciScan is designed to sit upstream of clinical care: self-collected screening that triages who needs a clinic visit, backed by a documented referral pathway for positive results and aligned with the Philippines' positive HTA financing recommendation.
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