PathogenDx Announces The CE Marking Of Its Next-Generation COVID-19 Testing Technology For The Simultaneous Detection Of SARS-CoV-2 (COVID-19) And Its Variants

The Technology Provides Medical Laboratories with a Rapid (6 hours), Affordable and Accurate Test for the Detection of SARS-CoV-2 ("COVID-19") and its Variants ("VOC") and ("VOI") without Sequencing

PathogenDx, a U.S.-based biotechnology company that is setting the standard in molecular testing through the widespread adoption of its innovative DNA microarray testing platform for the human diagnostics, food and agricultural industries, announced that its next-generation COVID-19 test technology, the Detectx-Cv+ test, has been CE marked in accordance with the requirements of the European Parliament and Council Directive 98/79/EC on in vitro diagnostic medical devices ("IVDD")¹. The PathogenDx Detectx-Cv+ test is a molecular biology RT-PCR test coupled with DNA microarrays designed to detect SARS-CoV-2 virus and variants of concern ("VOC"), variants of interest ("VOI"), and with the built-in ability to detect new mutations and emerging variants - all in one well.

"I am confident that the CE-marked Detectx-Cv+ test will save significant time and cost in the fight against the global pandemic, especially because genomic surveillance ("NGS Sequencing") of large numbers of samples is cumbersome, highly complex, extremely expensive, and requires a significant amount of time to provide a result," said Milan Patel, co-founder and CEO of PathogenDx. "By 2021, the SARS-CoV-2 virus had mutated more than 30 times - with Omicron jumping the mutation count to an unprecedented level. By the time the sequencing results were available, the data was already weeks old and had lost much of its public health value. The fact is, while sequencing is an excellent discovery tool, it does not provide the results or throughput we need at near 'real time' speed with this virus and its relentless 'mutation engine.' With the number of variants appearing as we have seen, receiving results two to three weeks later does not help. Detectx-Cv+ can identify both COVID-19 and its variants in just a few hours, while offering accuracy equivalent to next-generation sequencing ("NGS"), but with the simplicity of running on standard laboratory equipment that does not require high-end bioinformatics. The power of this technology is now available to routine molecular biology laboratories in Europe, instead of reserving variant testing to a few limited regional or national sequencing centers. Our technology, which will allow us to detect, understand and stop the spread of SARS-CoV-2 variants more quickly, is a winning solution for the future of public health."

Dr. Jean-Michel Pawlotsky, professor of medicine at Henri Mondor Hospital at the University of Paris-Est in Créteil, France, and his team evaluated the technology. Dr. Pawlotsky said, "With the increasing number of positive samples that need to be tested for variants, innovative technologies such as DetectX-Cv+ are promising because they improve the detection of new mutations to identify the spread of a new variant before it surprises us all."

PathogenDx's Detectx-Cv+ is based on an asymmetric, end-point reverse transcription polymerase chain reaction ("RT-PCR") coupled with DNA microarray hybridization. The fluorescence of each signal is measured by the plate reader and analyzed by proprietary software capable of activating new VOC/VOI by a simple algorithm update. This technology brings several key benefits to the market:

• High-throughput detection of COVID-19 and detection of variants
• Limit of detection of 3000 copies/mL
• Test turnaround time of less than six hours and same day results
• Costs a fraction of the time and expense of sequencing (~ 10x less)
• In a blind test coordinated by the U.S. National Institute of Health, 100% of the variants were detected with an assay limit in the 30 Ct range
• Ability to detect COVID-19 virus at a much lower LOD* (higher Ct value) while still being able to resolve variant detection and identification
• Uses standard laboratory equipment
• No high-end bioinformatics required

Patel added, "Even though vaccines are helping to thwart the spread of COVID-19, the variants are only increasing day by day, and even though Omicron is beginning to subside, we are all nervous about when the next variant will appear. We commend the European Union for being at the forefront of implementing state-of-the-art technologies for the detection of COVID-19 and identification of its variants. We hope that other countries will consider how innovative technologies such as Detectx-Cv+ can help minimize the devastating impacts of the COVID-19 pandemic and the incalculable damage in terms of lost lives and economic disruption."

¹ Today, COVID-19 tests are covered by the In Vitro Diagnostic Directive 98/79/EC (IVDD).