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XCR Diagnostics Validates its XCR® COVID-19 Assay

Molecular diagnostics company XCR Diagnostics has successfully completed the verification and validation of its XCR® COVID-19 assay and can now petition the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The company’s faster COVID-19 test leverages its patented rapid chemistry format to enable laboratories to double or even triple the number of patients tested per day for the disease caused by the SARS-CoV-2 coronavirus.

Currently, it takes one to three hours to complete a single coronavirus test on existing laboratory equipment. The Xtreme Chain Reaction (XCR®) test from XCR Diagnostics takes approximately 30 minutes on the same standard laboratory equipment, accelerating the laboratory’s testing capabilities.

The XCR test advantage derives from the company’s unique intellectual property, which dramatically improves the reaction kinetics and therefore reduces the reaction time. The ability for any laboratory to use XCR technology on its existing molecular testing equipment is key to early detection of the COVID-19 disease. XCR Diagnostics can deploy its XCR test across an existing laboratory’s installed base of machines, allowing even small laboratories to significantly improve patient testing output.

“Every healthcare system can easily adapt existing equipment to accept the XCR COVID-19 test, immediately achieving heretofore unprecedented speed in patient testing,” said Dr. Daniel Kolk, vice president of clinical development at XCR Diagnostics. “We have compared a number of influenza-like tests to our XCR test. Our test was completed in about 35 minutes while other tests took 60 minutes or longer to complete. When time is of the essence, switching to the COVID-19 test from XCR Diagnostics could immediately double any facility’s daily patient test volume.”

“We have verified XCR capabilities on a variety of systems deployed in laboratories today,” said Mark Powelson, CEO of XCR Diagnostics. “As an example, the two most widely used systems —Hologic’s Panther and Roche’s 6800 instruments— reported time to first results are 2.5 to 3.5 hours*, respectively. In that same period, we can provide 480 to 672 XCR COVID-19 test results.”

He added, “When lives are at risk in a pandemic, it’s critical to make our technology available as soon as possible so laboratories can begin community surveillance programs rather than continuing in their dangerously reactive mode of the past few months. We are collaborating with BIOLYPH to leverage their large-scale capacity and maximize the performance, shelf-life and ease-of-use of our XCR COVID-19 test. By supercharging testing volumes, we can proactively screen for COVID-19 at the population level, rather than having only the capacity to test patients already presenting symptoms.”

“At BIOLYPH, we are committed to providing the highest-quality lyophilization services and have been successfully doing so since 1993,” said Timothy Pearcy, founder and CEO of BIOLYPH. “Our team is committed to supporting XCR Diagnostics in supplying large volumes of tests to healthcare providers. We have the expertise and capacity in place to act once the XCR COVID-19 test gains EUA status.”

On the horizon …

While currently focused on alleviating the COVID-19 pandemic, XCR Diagnostics is also developing a proprietary portable instrument system called the Pyramid. This portable nucleic acid testing system will take full advantage of patented XCR technology to perform on-demand testing in ways conventional Polymerase Chain Reaction (PCR) systems cannot. The Pyramid will be smaller, lighter, and faster than comparable PCR systems, providing actionable results in less than 10 minutes. Because of its compact size and flexible power requirements, it can be more easily and cost-effectively deployed in the field, making it invaluable during a disease outbreak in hard-to-reach or medically underserved areas. Three tests have been developed for the Pyramid, with the first test entering FDA clinical trial in 2020.

* Times published by Hologic and Roche

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