APIS Assay Technologies
Pushing the Envelope of Innovative IVD Assays and Tools

There’s no denying that the COVID-19 pandemic is stressing the global healthcare sector at an unprecedented level. But, at the same time, the pandemic is also creating a perfect scope for healthcare executives to identify and improve the weak links within conventional healthcare infrastructures, thereby strengthening their overall crisis management capabilities.

Take the in-vitro diagnostics (IVD), for example. If the COVID-19 outbreak and the subsequent pandemic is teaching us anything, it is a greater need for accurate diagnosis. Only then can healthcare providers offer appropriate treatments to patients and stop the coronavirus from spreading further. Besides, improving the IVD technologies and assays can also help the healthcare professionals be better prepared to handle any similar situation in the future.

That being said, innovating their existing IVD portfolio is nothing short of a heavy lifting for the IVD companies, and they are certainly not ready for this on their own. This is majorly due to the recent FDA and European Union (EU) mandate that called for recertification of existing IVD devices and assays. For many IVD companies, the recertification process would require them to deploy all the available monetary and human resources to properly collate and submit their products’ revised clinical evidence and monitoring data. As a result, with the ongoing recertification processes and the current critical healthcare landscape in the mix, IVD product innovation is a territory that only a few handful of companies hold the calibre to venture into. What these IVD companies now need is an exceptional development partner who can help them tackle all these challenges and reinvigorate their solution decks.

Enter APIS Assay Technologies.

Based out of U.K., APIS goes above and beyond in its innovative CRO services to combine highly compliant and cost-effective molecular diagnostic development services. APIS can thus aid its clients in reinvigorating their IVD devices and molecular assays at scale, and at the same time, help them comply with the recent FDA and EU mandates. “In that sense, we are a CRO-plus company, whose capabilities connect contractual development of both molecular diagnostic tools and assays, and these attributes are strongly underlined by our bioinformatics and robust support services,” states Joachim Schorr, CEO of APIS.

To make the development of new molecular diagnostic devices an easy sailing feat for its clients, APIS offers on-demand diagnostic models for biomarker-based diagnostic assays, targeting oncology, autoimmune diseases, and more. These on-demand models are developed drawing from APIS’s experience in the respective fields, and therefore, can help the clients speed up their projects.

Meeting the Unmet Needs of In-Vitro Diagnostics

Schorr explains that, at present, many market-available disease biomarkers show a broad grey (equivocal) zone, where it becomes hard to define whether a disease is present in an individual or not. This has been a persistent problem in cancer diagnosis, and according to Schorr, the same applies to COVID-19 diagnostic tests as well; “The available biomarkers often fail to properly judge the severity of COVID-19 infection,” he says. Consequently, many early-stage patients can go unnoticed.

We help our clients enhance their diagnostic capabilities with new biomarkers that can narrow the existing grey zones even further and offer more accurate diagnostic results

“This is why we help our clients enhance their diagnostic capabilities with new biomarkers that can narrow the existing grey zones even further and offer more accurate diagnostic results,” Schorr adds further.

APIS works on diagnostic assets that have already been discovered by academic partners. APIS’s technology- and molecular content-agnostic nature perfectly positions them to develop tests for DNA, RNA, or other protein-based molecular contents on various detection platforms. “Besides, we can support the development of both single target and multiplex IVD assays by combining our expertise in bioinformatics and different automation platforms,” avers Schorr. “And not for once we compromise on quality. We keep the focus strictly on the intended use of the biomarker and regulatory requirements of the end-product,” the CEO mentions. The company also manages these development projects with milestone-based tracking to ensure that its clients are always compliant with the required regulatory protocols.

Schorr, at this juncture, shares a success story to better explain the difference APIS creates through its innovative approach in IVD. In one instance, a certain client required a large bacterial detection panel for their highly multiplexed testing system. The client wanted the panel to have twice the number of targets compared to the previously launched ones.

APIS utilised its strong expertise, particularly in infectious disease assay development, to design and develop the required panel. The panel is now going through different clinical validation studies, with the expectation of handing it back to the client for launch in 2022.

Creating a Safer Tomorrow

Driven by its success as IVD ‘CRO-plus’ company, APIS is now poised to enhance its capabilities even further by playing a catalytic role in the current IVD landscape. In consultation with an independent scientific advisory board, APIS has already selected new projects in the areas of different types of cancer, liver, and respiratory diseases. In terms of COVID-19 particularly, APIS is developing a new assay to measure immunity in patients as a consequence of either prior infection or vaccination with improved specificity to the novel coronavirus infection. These quantitative assays of the adaptive immune response are being designed by keeping in mind the reduced cold chain logistics and increased need for minimal cross-reactivity at pre-treatment stages. Notably, this project is now on a developmental fast-track with regulatory approval anticipated in the second half of 2021 and co-funded by the U.K.’s innovation agency, Innovate U.K.

It is also important to note that these efforts are now bringing APIS closer to its vision of establishing Manchester as a major Genomic Hub within North West England. And APIS is achieving just that within less than three years of operations in the IVD sector. Alongside this, APIS is also focused on expanding its footprints beyond Manchester. To this end, the company has recently acquired Beogenomics—a Serbian bioinformatics company. The acquisition is giving APIS an added advantage to take its end-to-end CRO-plus services to the U.S. as well. APIS is also looking to leverage Beogenomics’ expertise in genomic data handling to strengthen its offering even further.

Through these forward-looking efforts, APIS is now perfectly positioned to revolutionise and innovate the global IVD space through a professional development path for new biomarkers.