NEW YORK - UK molecular diagnostics company DNA Electronics (DNAe) provided new data last week to build out evidence for its diagnostic sequencing platform that the company says can return results on infectious diseases and cancer in hours.
The London-based company presented two posters at the Association for Molecular Pathology's annual meeting in Boston last week, one demonstrating its LiDia-SEQ platform can detect bloodstream infections and another on its use in cancer diagnosis and monitoring.
According to DNAe CEO Sam Reed, the platform is fully automated and requires a single instrument to get from sample to result. It uses semiconductor-based sequencing, first invented at Imperial College London and originally licensed to Thermo Fisher Scientific for its Ion Torrent sequencing platform. Reed noted that in DNAe's instrument, the sequencing portion is "very similar" to Ion Torrent, but the rest is different and intended to facilitate rapid, cartridge-based testing.
Users insert a blood tube into a cartridge that is then loaded onto the LiDia-SEQ instrument. The company uses a proprietary method for lysing the samples and proprietary beads to capture and isolate pathogen DNA or RNA.
It uses a patented method to control the amount of target DNA that is placed onto the chip. The chip surface contains microwells that allow for a patented clonal amplification process. After sequencing, base calling is performed locally on the instrument and the sequence data is compared to the firm's proprietary database of pathogen genomes and antibiotic resistance sequences to generate a report of the results, Reed said.
The first application will be for bloodstream infections and sepsis to detect pathogens and antibiotic resistance markers directly from whole blood. The study presented on the poster used a prototype of the instrument to show that it can identify pathogens and antibiotic resistance in a single day.
According to the poster, DNAe's instrument was able to detect spiked organisms at concentrations as low as 3 colony forming units per milliliter.
"It demonstrates [LiDia-SEQ's] ability to confront the challenge of sepsis detection," Reed said - detecting a small number of targets directly from blood without several days of culture.
Same-day detection would allow clinicians to put patients on the right antibiotic in hours, he added, rather than using broad-spectrum antibiotics that can be harmful or ineffective.
The company also plans to use its instrument for cancer monitoring and therapy selection, Reed said. For that application, the testing process is largely the same but the goal is to detect circulating tumor DNA in the blood. The firm has a proprietary process for plasma separation, he noted, which happens on the cartridge without the use of a centrifuge. The firm has also developed a method for enriching ctDNA from non-tumor cell-free DNA in plasma, which it calls Specific Variant Capture.
According to the firm's poster, the plasma isolation method is equivalent to the standard double-centrifugation manual method. The data also showed that using Specific Variant Capture allowed for 60-fold to 115-fold enrichment of ctDNA. The authors noted that enriching for ctDNA "changes the oncology NGS assay detection paradigm from a quantitative measurement (i.e. [variant allele frequency]) to a binary response and thus would only be applicable in certain clinical contexts where very high sensitivities are required to detect ultra-low frequency mutations," such as early cancer detection, minimal residual disease detection, or resistance monitoring.
The platform's sensitivity could allow clinicians to make therapeutic decisions and ensure patients don't get therapy they don't need, Reed said. It may also be able to detect recurrence early, similar to other liquid biopsy tests in the cancer space. However, the ability to perform recurrence monitoring on one instrument would encourage its placement in cancer clinics and integration into routine patient care, he said.
Currently, the company has alpha prototypes available and is building beta prototypes, with plans to commercialize the platform in 2027 for bloodstream infection research, Reed said. In parallel, DNAe will start clinical trials to seek clearance from the US Food and Drug Administration for the bloodstream infections application. The firm has already received breakthrough device designation from the agency and has a "great dialogue" with the FDA, Reed noted.
The cancer application is at an earlier stage of development, but the company plans to start with breast cancer and move to lung cancer, he said.
DNAe is working with contract manufacturing organizations to build the instrument and cartridge but is producing certain proprietary components in house.
It is also working on collaborations with hospitals to conduct additional research and build out its evidence base in the first half of 2026, and it is meeting with undisclosed large diagnostic companies to discuss opportunities for partnerships, he added.
DNAe is also developing tests using additional sample types such as cerebrospinal fluid, and is working on tests for respiratory diseases and other infectious diseases.
Rishi Joshi, the firm's VP of product management and business development, noted that the company is also investigating the the platform's use for companion diagnostic and pharmacogenetic applications.
The company plans to directly distribute the platform in certain markets but hopes to partner with for additional markets and applications, Reed said. The first launch is planned in the US, with the UK and Europe to follow shortly after.
The firm aims to target hospitals first, both large and small ones, he said, noting that "there is nothing out" that combines sequencing-based analysis with rapid turnaround
LiDia-Seq "can address diseases where time matters or diseases where integrating with the patient care pathway matters," he said.