NEW YORK – After having cut its teeth on the cannabis, food, and COVID-19 testing markets, PathogenDx is poised to launch a microarray-based test for urinary tract infections later this year.
The new UTI assay will enable the identification of 26 pathogens and 20 associated antimicrobial resistance genes in one multiplexed test and will support the selection of targeted therapies for patients, according to CEO Milan Patel.
The Scottsdale, Arizona-based firm plans to begin selling its UTI assay for research use only in the third quarter and intends to obtain US Food and Drug Administration clearance for the test, Patel said.
According to Sue Evans, who advises PathogenDx on clinical and human diagnostics, the firm has clinical partnerships in place to validate the test.
The company's first diagnostic assay, a test for SARS-CoV-2 called DetectX-Rv, gained Emergency Use Authorization from the FDA in 2021, and a SARS-CoV-2 subtyping test obtained a CE-IVD mark in Europe in 2022.
The UTI assay will cement the firm's move into the molecular diagnostics market, where it believes its Dynamic Dimensional Detection (D3) arrays have advantages over other technologies such as quantitative PCR and next-generation sequencing.
The D3 Array technology features a three-dimensional, lattice-like architecture deposited on a substrate. This allows targets to move through the structure and bind to probes at room temperature with high sensitivity and specificity, according to the company. The arrays can multiplex up to 100 targets and can be run in a 96-well plate format using standard laboratory equipment, making it easier to integrate the technology into existing setups.
The technology "gives you the best of qPCR in terms of cost and throughput but can provide the single-gene and SNP-level resolution and multiplexing of sequencing," said Patel, who was previously CFO and chief commercial officer of array-based blood screening company GMSbiotech, formerly Genomics USA. PathogenDx CSO Michael Hogan was CSO and a cofounder of GMSbiotech. GMS's arrays relied on probes on a surface and were protected by patents licensed from Baylor College of Medicine, where Hogan, the principal inventor, was on faculty.
PathogenDx's D3 Array technology, in comparison, was invented within the company, which owns the IP. Probes are held in a three-dimensional assembly at a distance from the array surface, improving their affinity. The technology can also support multiple amplification methods, including PCR, real-time PCR, and nucleic acid sequence-based amplification (NASBA).
The company initially focused on the cannabis microbial testing market, where it has more than a hundred laboratory partners. Medical marijuana is legal in 38 US states and the District of Columbia, all of which mandate quality control testing of cannabis products. The firm's Detectx Combined test kit, which assays for both bacterial and fungal pathogens, has been widely adopted in the market since 2017, according to the company, which allowed it to generate income and showcase its technology in preparation for developing clinical diagnostic tests.
In the food safety testing market, PathogenDx launched the EnviroX-F Assay in 2020, which tests for Salmonella, Listeria, and Listeria monocytogenes, and it is preparing to launch a new assay, SeroX, to test for 13 Salmonella serotypes.
According to Patel, the array tests have advantages over qPCR and next-gen sequencing assays in terms of cost and turnaround time. He noted that PathogenDx's tests cost $50 per sample or less. "Food is sitting in crates waiting to be released, and when you charge $150 to sequence a food product, there is an economic disconnect," he said. "That's why sequencing isn't being embraced by the food world."
PathogenDx's forthcoming UTI assay will give the company the opportunity to showcase its technology in a new market where at least one test, OpGen's multiplex PCR-based Unyvero assay, was just submitted to the FDA for de novo classification weeks ago.
Also, Llusern, a Welsh company, is preparing a point-of-care test for UTIs that relies on loop-mediated isothermal amplification. Llusern said last month that the test should launch next year. Vela Diagnostics of Hamburg, Germany, last year rolled out a research-use-only multiplex PCR test for UTI diagnosis and AMR resistance that runs on the Thermo Fisher Scientific QuantStudio 5 real-time PCR system.
According to Patel, PathogenDx has high hopes for its continued foray into the clinical market and at some point in the future might even decouple its cannabis and food testing businesses from its diagnostics business. "That's the plan going forward," he said, "to focus on medical microbiology."