PathogenDx, a provider in next-generation microarray technology for better health and safety, has expanded the reach of its patented multiplexed molecular testing technology–Dynamic Dimensional Detection (D3 Array)–beyond the cannabis and hemp sectors. 

The company is bringing its D3 Array—which addresses the challenges microarray technology has suffered in prior generations as well as the gap that qPCR and next-generation sequencing (NGS) has created in multiplexing, performance, throughput, and cost—to the clinical, food and agriculture sectors.

The company’s proprietary D3 Array features a flexible, open, lattice-like architecture that is rich with highly accessible target-probe binding sites, the company says. The benefit of this is the ability of amplicon targets to: move easily through the 3D structure; locate target:probe binding sites; and bind more easily with significantly reduced steric hindrance. Consequently, the duplex pairing hybridization reaction is rapid at room temperature and delivers high sensitivity and specificity results to labs and their clients. 

“Today, even with two well-established diagnostic technologies, there are instances where sensitivity and multiplexing limitations of the well-adopted qPCR are insufficient and the costs, turn-around time and heavy lifting needed for bioinformatics of NGS are problematic in the clinical, food and agricultural sectors,” says PathogenDx Co-founder and CEO Milan Patel. “For example, in the traditional array, a probe monolayer is printed directly onto a surface, and typically the probe is much smaller than the amplicon itself, which provides limited binding access to the much longer amplicon target. This essentially reduces target binding affinity due to surface crowding. In contrast, our D3 Array features a 3D cross-linked lattice structure with surface-bound oligonucleotide probes accessible throughout the 3D structure, thus increasing access and allowing for a faster, higher affinity target amplicon binding reaction.” 

Patel added, “The D3 Array has emerged as our core of the technology platform, and the tests built upon it are in commercial deployment in more than 100 regulated laboratories. Additionally, our D3 Array is a more flexible, higher throughput and cost-effective approach than a series of multiplex qPRC/PCR assays. It also delivers a much faster and more affordable alternative to NGS, delivering high specificity, but without the complex sample prep, data analysis and reporting encumbered with NGS.” 

PathogenDx’s D3 Array is readily adaptable to high throughput 96-well plate processing from sample to answer. 

“PathogenDx D3 Array provides the best-of-both-worlds alternative,” says Lux Diagnostics CEO and Founder Jonathan Goss. “It holds promise in clinical diagnostics, where accelerating medical diagnosis and saving money are high priorities. We have been able to run PathogenDx’s Detectx-Cv kit for COVID variant testing for more than a year, and at some points the platform was able to process 1,200 samples a day in variant identification. The D3 Array allowed us to get single gene mutation level identification on positive COVID samples in a single day, whereas NGS would have taken weeks. This is the promise that PathogenDx technology holds in terms of addressing other clinical diagnostics areas where there is a large unmet need in throughput, cost, accuracy and time to yield results.”