NEW YORK – Dutch life sciences startup Predica Diagnostics is developing an assay for cervical cancer screening and early detection based on a proprietary targeted RNA sequencing technology.
The Radboud University Medical Center spinoff is hoping to launch a research-use-only (RUO) product early next year followed by a clinical assay as it obtains regulatory approval.
Predica has developed a platform technology that enables gene expression measurement, said Marco de Boer, Predica cofounder and CEO. "Our unique selling point is that we can measure both RNA [quantity] and sequence information that will be important for future screening procedures," he said.
Founded in 2019, Predica obtained its foundational technology, dubbed targeted circular probe-based RNA next-generation sequencing (ciRNAseq), from research conducted by company cofounder and CSO William Leenders while he was a professor at Radboud UMC, de Boer said.
Predica has secured an exclusive license from Radboud UMC for the development and commercialization of ciRNAseq, which deploys single-molecule molecular inversion probes to help quantify and analyze target RNA molecules using next-generation sequencing.
According to de Boer, one potential advantage of ciRNAseq is its ability to measure the expression of hundreds of gene targets at once. Additionally, unlike multiplex PCR, it allows mutational analysis of the target from the sequencing data. Meanwhile, compared with whole-transcriptome sequencing, ciRNAseq demands less bioinformatic resources, he added.
"We position our technology between multiplex PCR because we can target [many] more molecules and whole-RNA sequencing, where you need lots of bioinformatic [resources]," de Boer noted.
Predica's first product will be an assay for cervical cancer early detection called CervicaDx. According to de Boer, the assay analyzes 200 to 300 biomarkers including RNA from high-risk human papillomaviruses (HPV) as well as host oncogenes and other malignancy markers linked to cervical cancer development.
As part of the CervicaDx workflow, RNA molecules are first isolated from cervical scrapes or vaginal swab samples and then undergo reverse transcription to generate cDNAs. After that, proprietary probes are deployed to capture target cDNAs, generating libraries for sequencing. De Boer said the company's technology is agnostic to sequencing platforms, including those, for instance, from Illumina, Oxford Nanopore Technologies, and MGI Tech, which the company inked a partnership with earlier this month.
After sequencing, data are analyzed by a bioinformatic analysis pipeline developed by Predica to help interpret the results and generate a risk profile for cervical cancer. De Boer said the company has so far trained the algorithm with roughly 3,000 clinical samples through its collaboration with several hospitals in the Netherlands and Germany, such as Amsterdam UMC, Radboud UMC, and Charité in Berlin.
Currently, Predica is developing CervicaDx into a kitted product and working to obtain certification under the European Union’s In Vitro Diagnostic Regulation. According to de Boer, the anticipated product will include all necessary reagents, such as enzymes and probes, as well as the analysis pipeline to allow customers to carry out the entire ciRNAseq workflow.
To that end, the company has applied for an International Organization for Standardization (ISO) 13485 certification, de Boer said, and signed on a notified body with a goal of obtaining IVDR certification by the end of 2026.
De Boer said CervicaDx target customers will be clinical labs and healthcare providers to help diagnose cervical cancer, adding that the company also hopes to break into the cervical cancer screening market.
While Predica works to clear regulatory hurdles, de Boer said the company also plans to release a research-use-only product for HPV analysis in the first quarter of 2025.
Predica is one of many companies vying for a piece of the cervical cancer diagnostics market, and de Boer acknowledged that the field can be "very competitive." While Predica’s test promises to measure both high-risk HPV and host response, it remains to be seen how it will stack up against the existing competitors.
IP wise, de Boer said the company has secured one patent and have two pending applications pertaining to the ciRNAseq technology covering "key geographic areas." Besides cervical cancer, the company hopes to harness its technology for other women's health applications, he noted, including an ongoing research effort to identify potential biomarkers in the vaginal microbiome for endometriosis.
Based at Radboud UMC's campus in Nijmegen, Predica currently has five full-time employees, according to de Boer. The firm has so far primarily been funded by roughly €1.2 million (about $1.3 million) in loans and grants, and it has generated some revenues from the collaboration with research institutes in the Netherlands.
The company is also hoping to raise around €4 million in a current financing round to help it further develop and validate CervicaDx as it goes through the IVDR certification process and roughly double the company's workforce.
Predica is also interested in the US market, where it is forging collaborations and seeking additional funding. The company hopes to garner approximately $10 million from both US and European investors to seek regulatory approval in both markets, de Boer said.