Healthcare Industry News:  CT 

Diagnostics Regulatory

 News Release - July 21, 2021

PathogenDx Receives CE-IVD Mark for Its Microarray-Based DetectX-Rv Test for COVID-19

The low-cost, high-throughput test will now be available for qualified laboratories across the European Union

SCOTTSDALE, Ariz., July 21, 2021 -- (Healthcare Sales & Marketing Network) -- PathogenDx, Inc., an Arizona based biotechnology company which has developed a multiplexed microarray DNA-based pathogen testing platform, today announced that it has received the CE-IVD Mark for the sale and distribution of its patented DeteCTX-Rv Microarray Assay for COVID-19 testing across Europe. The CE-IVD mark is in conformance with the European Union In Vitro Diagnostic DireCTive 98/79/EC.

PathogenDx's DeteCTX-Rv microarray utilizes nasopharyngeal swabs and nasal aspirate or fluid to deteCT SARS-CoV2 within three hours after RNA extraCTion, and has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Its multiplex system also has the capability of pooled sample testing for the deteCTion of SARS-CoV2 in multiple samples at one time, dramatically increasing COVID-19 testing throughput.

DeteCTX-Rv delivers superior accuracy based on its proprietary technology of analyzing dozens of probes in COVID-19 regions of the viral genome, delivering a Limit of DeteCTion of 1,000 copies/mL. The test also ensures 100% specificity by analyzing the sample in triplicate for each patient swab within each array, not just once as conduCTed in currently approved COVID-19 tests.

"Receiving the CE-IVD Mark for our DeteCTX-Rv test is a massive milestone for our company and will not only help deteCT COVID-19 in Europe as the pandemic sweeps on, but with the company's follow-on DeteCT-Cv Clade variant test helps identify the Variant of Concern and/or Variant of Interest from any positive result processed either from DeteCTX-Rv or any other molecular platform" said Milan Patel, Co-founder and CEO of PathogenDx. "Although we are in the second year of the pandemic and vaccine distribution has greatly improved, COVID-19 and its variants persist in our global community. The virus will continue to mutate and we need to be able to identify if an infeCTed patient has a particular variant in order to provide the most effeCTive clinical and therapeutic treatment. Global distribution of diagnostic tests like our DeteCTX-Rv test is crucial in helping limit the spread of COVID-19 and its variants."

DeteCTX-Rv uses standard off-the-shelf lab equipment and was developed to meet daily test volumes without incurring economic loss on unused wells. The test is ideal for small and medium-sized clinical/CLIA labs in need of low-cost testing, especially ideal for rural areas.

To learn more, please visit www.pathogendx.com.

About PathogenDx

Headquartered in Scottsdale, Arizona, PathogenDx's mission is to become the new standard in molecular-based testing through widespread adoption of its advanced microarray testing platform for the human diagnostics, food and agricultural industries. PathogenDx's technology can rapidly identify and deteCT up to 50 pathogens all in a single test, in 6 hours providing triplicate data per analyte for certainty in results with a simple and easy process. The company's DNA-testing produCTs – DeteCTX™, QuantX™, and EnviroX™– are disrupting conventional microbial and molecular technologies to identify, deteCT and quantify pathogens that are a threat to human health, their ecosystem and the environment. This technology will help growing businesses deliver safer produCTs and healthier lives, while preventing billions of dollars in losses from infeCTion and contamination. For more information on how you can utilize this simple, powerful and inexpensive DNA-based pathogen testing, visit www.pathogendx.com.


Source: PathogenDx

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