FirsTeckBio
Italy-based IVD company supporting selected diagnostic systems for laboratories, plus IVD-focused CRO, performance studies and IVDR services for manufacturers.
FirsTeckBio is an Italy-based IVD company. We support selected diagnostic systems for Italian hospitals, private laboratories and clinics, and provide IVD-focused CRO and IVDR services for manufacturers.
Our English diagnostic portfolio presents two systems: the RealMind MCL60 direct chemiluminescence immunoassay analyzer and the Rocgene iFIND S2 / S4 / S8 sample-to-result molecular platform. Commercial, application and technical support is coordinated locally in Italy.
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.
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.