FirsTeckBio
Italy-based IVD company selling selected diagnostic systems with local support, plus IVD-focused CRO, IVDR services and RT Clinica EDC for manufacturers.
FirsTeckBio is an Italy-based IVD company. We distribute selected diagnostic systems into Italian hospitals, private laboratories and clinics, provide IVD-focused CRO and IVDR services, and offer RT Clinica EDC for performance-study data.
On the distribution side, we bring selected IVD instruments and reagents — chemiluminescence immunoassay (CLIA), droplet digital PCR, immunofluorescence and POCT — into Italian laboratories with local Italian-language demo, installation, training, consumables supply and after-sales.
For manufacturers, we design and run performance studies under Annex XIII and ISO 20916:2019, draft technical documentation and assemble evidence packages structured for notified-body review. RT Clinica adds versioned eCRFs, review, signatures, lock and traceable exports as a dedicated software product or separately scoped CRO data layer.
The difficult studies — run in Italy, and published.
Two things separate a CRO that assembles paperwork from one that generates evidence: whether it can run the demanding studies, and whether the results stand up outside the technical file. Ours are presented at peer-reviewed congresses and published in journals.
- Four markers, four matrices, four comparators — one study: The cardiac panel (hs-cTnI, hs-cTnT, NT-proBNP, D-Dimer) combined 99th-percentile cutoff establishment with CLSI EP05 precision while method-comparing against four independent platforms in parallel, across serum, plasma and whole blood. Aligned to IFCC Cardiac Troponins.
- Plasma Alzheimer biomarkers, multicentric cutoffs: Aβ 1-42, Aβ 1-40, pTau-181 and pTau-217 in plasma — multicentric cutoff establishment with ROC analysis. Among the most demanding low-concentration immunoassay designs in routine diagnostics.
- Class D against EU reference panels: HIV, HBV, HCV and syphilis — performance studies validated against EU reference panels and documented to Common Specifications 2022/1107, where LoB/LoD/LoQ per CLSI EP17 and low-positive specificity decide whether the file holds.
- Peer-reviewed, not only filed: Four posters at Euromedlab 2025 (Brussels), multiple posters at Elas National Congress 2025 (Italy), and a peer-reviewed publication in Natural Aging (2025) on six cytokine markers for clinical outcome prediction.
- An academic partner, not only a lab: Ongoing collaboration with the University of Perugia, Department of Medicine and Surgery — performance evaluation studies together with a funded microbiology scholarship.