SCOTTSDALE, Ariz., Dec. 22, 2021 /PRNewswire/ — At a time when the U.S. Food and Drug Administration (“FDA”) is considering Emergency Use Authorization submissions for SARS-CoV-2 variant genotyping assays, Milan Patel, co-founder and CEO of PathogenDx, an Arizona-based biotechnology company that has developed a multiplexed microarray molecular-based pathogen testing platform, issued the following letter to U.S. President Joe Biden, urging him to implement next-generation diagnostic technologies in the battle against the COVID-19 pandemic.
Leveraging its learnings from the agile development of COVID-19 diagnostics, PathogenDx has already innovated upon its multiplexed microarray testing platform, introducing an expanded 96-well plate, improved sample preparation and streamlined data reporting with the introduction of a new, customized portal. The rapid, affordable variant detection for SARS-CoV-2 is available now. The company’s National Institute of Health (“NIH”)–supported technology would provide invaluable insight to guide scientific discovery and public health decision-making – not someday, but today – and does so without the time and expense of sequencing. PathogenDx’s Detectx-Cv has already detected major variants, including the Omicron variant; provides results in four hours after a positive sample from a Q-rt PCR test; runs up to 576 samples in a single shift; and is fraction of the cost of NGS Sequencing.
These next-generation technologies will save significant time and money in the fight against the global pandemic, particularly when sequencing assays to determine genotypes for a large number of samples are complex, costly and take a lot of time to deliver a result. Previously, the FDA provided validation recommendations for select developers of high-volume variant PCR genotyping assays. However, these next-generation technologies have yet to be implemented in the U.S.
December 22, 2021
The Honorable President of the United States Joe Biden
The White House
1600 Pennsylvania Avenue
Washington, D.C. 20500
Dear President Biden,
As the CEO of a biotechnology company that has reinvented molecular-based testing to identify pathogens faster, easier and more cost-effectively, driving greater safety and business optimization in fields ranging from COVID-19 testing to healthcare to agriculture and food safety, I am urging you to implement a next-generation of diagnostic technologies that are capable of reducing the time and cost of COVID-19 detection and its variants as a result of constant and ongoing mutations of the virus.
While we remain grateful for your aggressive scientific approach in this fight and the FDA’s decision to consider Emergency Use Authorization submissions for SARS-CoV-2 variant genotyping assays, the ongoing impact of the COVID-19 pandemic is nothing short of devastating. As the Omicron variant ravages our country, incalculable damage in terms of lives lost and economic turmoil has ensued.
Recently, The New York Times published an article titled: Why Didn’t the U.S. Detect Omicron Cases Sooner?, in which the author stated, “genomic surveillance has improved enormously in recent months, but the system has built-in delays, and blind spots remain,” and I couldn’t agree more with the article. The author went on to say that “just a day after South African scientists first announced the discovery of the Omicron variant, Europe reported its first case. The new coronavirus variant was in Belgium. Before the weekend was out, Australia, Britain, Canada, Denmark, Germany, Israel, Italy and other countries had all found cases. But in the United States, scientists kept searching.” It was several critical days later when American officials announced that scientists had found the new variant, but by then, Canada had already identified six cases, and Britain had found more than a dozen.
The Omicron variant is an alarming cause for concern due to the variants’ eye-opening number of mutations and ability to spread. Yet, this will not be the last variant. New variants could pop up across the globe at any time, which is why our country can no longer afford to embrace blind spots and delays within our genomic surveillance system.
While we commend your Administration for increasing funding to fight COVID-19, launching the CDC sequencing consortium, shining a spotlight on the need for concern regarding the emergence of new variants and recent movement at the FDA’s — we already have the technology in our hands to enable our country to more quickly and cost-effectively identify, detect and test for COVID-19 variants and community spread.
At PathogenDx, we have developed an ultra-rapid variant detection technology called Detectx-Cv to analyze the COVID-19 virus’ genetic material from samples in a fraction of the time, with a fraction of the cost and resources compared to what it takes with Next Generation Sequencing. PathogenDx’s multiplex microarray technology enables us to quickly identify new mutations and specific variants, as well as keep track of how the virus is evolving and spreading. As more lethal variants or those less responsive to vaccines and therapeutics are identified, public health officials and epidemiologists will need this vital detection to drive the level of response now more than ever. By implementing next-generation diagnostic solutions that more quickly identify new variants, our communities and businesses will have a better chance of gaining more timely and accurate insights, ensuring we protect public health and trust, which will inevitably support our desire to return to normalcy.
Today, PathogenDx is also one of few companies that can simultaneously deliver detection of COVID-19 and identify the specific variants of the virus that are extending the carnage of the pandemic — and can do so with remarkable efficiencies. Variant surveillance brings enormous value to helping public health officials make informed decisions for their communities, guiding researchers in better understanding the spread of the SARS-CoV-2 virus, and ultimately, helping us all react to the risks of the virus responsibly based on the best information available. Our technologies are already supported by the National Institutes of Health (NIH), as part of its Rapid Acceleration of Diagnostics (RADx) program for the identification of community-spread variants, and our individual tests have shown to produce variant results in four (4) hours after a positive sample from a qPCR test. Also, we can run up to 576 samples in a single shift and our technologies cost way less than NGS Sequencing.
Next-generation diagnostic technologies need to be implemented now, and we look forward to working with you and your Administration to broaden access to best-in-class diagnostic solutions that can quickly, and also cost-effectively, help our country best combat the ongoing pandemic.
U.S. Senator Chuck Schumer
U.S. Senator Mitchell McConnell
U.S. Senator Kyrsten Sinema
U.S. Congresswoman Nancy Pelosi
U.S. Congressman Kevin McCarthy
Headquartered in Scottsdale, Arizona, PathogenDx’s mission is to become the new standard in DNA-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 the century-old practice of petri-dish testing 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.
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