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PDx News & Insights

PathogenDx delivers viral testing solutions for a new era dominated by the global pandemic,  and is at the forefront of bacterial and fungal testing as well. We are answering the challenge of individuals, communities and the moment itself, while monitoring the global conversation around pathogen testing to offer even more powerful solutions. Catch up on the latest news driving the future of safe.

  • Numerous federal grants received to enhance core platform | October 1, 2020

    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.