Recently, the PathogenDx Team has been fortunate to have received a Grant from the National Institute of Allergy and Infectious Disease (NIAID) and a companion Contract from the NIH Rapid Acceleration of Diagnostics (RADx) program. Both are highly competitive, each with less than a 10% success rate, which serves as a testimonial to the innovative nature of the PDx technology platform and the quality of it Team.
NIH RADx funding is a contract to develop a microarray-based COVID-19 assay based on core technology that is similar to that deployed by PathogenDx for its bacterial and fungal tests, but where the RNA genome of SARS-CoV-2 (i.e. COVID-19) rather than bacterial or fungal DNA is the target. With RADx funding, this microarray based COVID-19 test has been scaled so that it can now deployed in a relatively standard 96-well plate format (one PDx microarray/well) rather than the 12-well slide format in current use for all PDX bacterial and fungal testing. Having been “morphed” into such 96-well plates, the microarray platform becomes much more amenable to very large scale manufacture and very high throughput, automated testing.
The resulting 96-well plate based COVID-19 assay, being a direct extension of the other DetectX products is referred to as “DetectX-Rv”, where the suffix “Rv” signifies that the test is targeted to a Respiratory Virus.
To date, RADx funding has enabled development and validation of very large scale, 96-well based DetectX-Rv microarray manufacture (hundreds of 96-well plates/day) to be scaled in the RADx program to support up to 2M COVID-19 tests/month. RADx has also funded the integration the DetectX-Rv assay with “best of breed”, off-the-shelf lab automation, to enable “hands free” lab throughput as high as 560 samples/shift
The companion NIAID funding is focused on optimization of the “wet chemistry” of DetectX-Rv (which like all other PDx products is based on PCR) especially the introduction of new, automated ways to prepare samples and fine-tuning of its PCR “front end” in a way that is most amenable to high throughput automation. The work also includes new approaches to expand the current DetectX-Rv test content to include multiple respiratory viruses other than COVID-19.
Spin-offs. Although those two Federal funding sources are both targeted to COVID-19 and related “Flu-Like” viruses, with a special focus on human diagnostic (IVD) applications, this Federal Support will foster technical “Spin-Offs” into other PDx businesses.
1). EnviroX-Rv. The companion to DetectX-Rv for screening for COVID-19 contamination on surfaces and in the air, “EnviroX-Rv” has already been deployed as a manual environmental screening test, in the standard 12-well slide format, with surface swabs or air samples as the sample source for analysis. EnviroX-Rv is technically very similar to DetectX-Rv. Therefore the RADx and RO1 funded scale-up of COVID-19 testing for IVD applications can be immediately transitioned to use in EnviroX-Rv for environmental screening, especially for those labs which might benefit from very high throughput, automated sample processing.
2). DetectX, QuantX. Although DetectX-Rv is a COVID-19 test, its underlying core microarray technology is the very similar to that deployed for the DetectX and QuantX products. Thus, we envision that as other PDx businesses which use DetectX & QuantX (Cannabis, Food, Ag) grow in scale and corresponding per-shift throughput demand, the higher throughput, 96-well based testing which emerges from NIH-funded COVID-19 testing can begin to permeate into each of those other PDx market segments.