solutions to grow your business

Like the ReceptIVFty assay this is also an assay developed, CE-IVD certified and produced in house. This assay is to exclude your risk of developing gluten intolerance based on a genetic profile screen of your HLA region in your genome. The disease is called Celiac Disease (CD).

For more information click the link below

CeliaSCAN

The ReceptIVFity marketed by ARTPred is an assay based on the analyses of the vaginal microbiome by the ISpro technology (inBiome) providing insight on the chances to get pregnant. With an unfavourable profile the chance of getting pregnant is only 5%.

COVID-19 is the disease caused by the SARS-CoV-2 virus which is most commonly detected by either PCR, antigen, antibody, or Volatile Organic Compound (VOC) analyses. In March 2020 we founded CoronaLab.eu the first company in NL helping travellers to get a travel certificate.

Microbe&Lab is involved in developing new diagnostic assays based on specific requests for our own company and for clients. The development can range from basic (primer and probe definition and evaluation) to making a complete CE-IVD certified diagnostic assay.

Microbe&Lab is an ISO certified lab and is validated by the RIVM for performing for instance SARS-CoV-2 RT-PCR. We can perform regulatory support and give advice (including CE-IVD//IVD-R registration) to enhance process quality and fulfill regulatory requirements.

Microbe&Lab is collaborating with a VC to explore implementation of POC technologies in Africa in the field of Female Reproductive and Maternal Health, including sexually transmitted infections (STI).

Within this collaboration the focus is on the adaptation, optimisation, analytical validation, and operational implementation of molecular point-of-care (PoC) diagnostic systems for use in low- and middle-income country (LMIC) health systems. In a currently running demonstration project in Kenia, our collaboration is co-developing technology layers that enable the FlashDx platform to function reliably under real-world LMIC conditions.

The FlashDx multiplex POC system is a CE-IVD-R certified, chip-based real-time PCR platform designed for rapid, accurate, and affordable detection of multiple pathogens at the point of care. Its 1000E and its modular 4T/8T/12T instruments provide fully integrated sample extraction, amplification, and detection within a single disposable cartridge, enabling true sample-to-answer diagnostics in under one hour. Compared to systems such as GeneXpert, which require costly service contracts and provide only one to two STI targets per cartridge, FlashDx offers greater multiplexity (15–25 targets), faster turnaround times, and significantly lower operational costs.

The FlashDx platform already includes multiple CE-IVD assays—such as the arbovirus panel, respiratory panel, and Group B Streptococcus (GBS) assay—, confirming that the underlying system is fully mature. The FlashDx STI panel is currently research-use-only; however, it has undergone extensive analytical validation. The ongoing pilot with the Kenya Medical Research Institute (KEMRI) further demonstrates strong performance under controlled laboratory conditions. Assay development in molecular diagnostics is a continuous process, particularly as new antimicrobial-resistance markers emerge.

Kenya faces a high burden of undiagnosed sexually transmitted infections. The FlashDx STI panel simultaneously detects six high-priority pathogens (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma spp.) from minimal sample volumes, enabling same-day diagnosis and targeted therapy in outpatient, PrEP, and maternal-health settings.

In collaboration with KEMRI, the STI panel has already been used in a pilot study among more than 400 adults receiving PrEP and HIV care in Kisumu. This pilot assessed analytical accuracy only, comparing FlashDx with the Mikrogen PCR platform in a controlled laboratory environment staffed by trained laboratory technologists. The study was not a demonstration to clients, nor did it address workflow integration, cartridge handling in clinical environments, connectivity, power-supply resilience, or the device’s operational performance in decentralized clinics. Diagnostic accuracy is only one component of technology adoption; as emphasized by stakeholders at the Task Force Health Care meeting, pilot studies are not considered sufficient evidence for procurement decisions. A formal demonstration is required to assess the technology’s functionality under real-world conditions.

The final discrepancy analysis for the pilot study is still ongoing, with results expected for publication mid 2026. While these findings are scientifically important for national STI strategies, they do not evaluate the operational performance metrics required by Kenyan buyers and implementers.

Our core activities in this collaboration focus on the development of software, quality-control protocols, verification workflows, and implementation frameworks for molecular point-of-care diagnostics, rather than wet-lab assay or hardware development. Microbe&Lab B.V. serves as a laboratory showroom and applied testing environment where these frameworks are demonstrated on FlashDx PoC systems in real-world clinical and near-clinical settings.

Coronalab.eu is an online platform which helps individuals and companies to test for COVID-19. We do this with a fast COVID test service (PCR test, the Rapid test and the Serological test) with which we can guarantee same day results. Tests include a free travel certificate.