EMERYVILLE, Calif. (May 26, 2022) – Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has received European CE mark designation for its eLab S1 assay panel for use with a lithium heparinized whole blood sample. The eLab S1 was previously granted European CE mark approval in 2019 for use with a plasma sample. The new approval provides even faster results than the Company’s earlier plasma-based panel by eliminating the step of first centrifuging blood to produce a plasma sample.
“We are very pleased to report CE mark designation in Europe for our S1 assay panel using a whole blood sample type,” stated David Ludvigson, President and Chief Executive Officer of Nanomix. “We were already at the forefront of the diagnostic market, however, this approval provides even faster sample-to-results to better assist healthcare providers during their evaluation of patients with suspected critical infections, such as sepsis. By testing directly from a whole blood sample, valuable time is saved by skipping the processing steps currently required for different sample types. The use of whole blood increases accessibility and promotes the true mobility of our platform; not all decentralized healthcare locations have the necessary equipment to centrifuge and prepare different sample types required for testing. Importantly, this is the first point-of-care product on the market that uses whole blood for PCT, one of the most important diagnostics used by providers while diagnosing critical infections and informing antibiotic treatment, which we believe will result in better patient outcomes.”
The S1 Assay panel was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for Lactate (LAC), CReactive Protein (CRP) and PCT from a single plasma sample or venous whole blood sample type. The assay runs on the eLab Analyzer with results available in approximately 12 minutes, versus the current diagnostic solutions which can take hours to provide a test result.
The Nanomix eLab system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing.
Nanōmix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanōmix ® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections as well as the rapid identification of current and prior SARS-CoV-2 infection. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit www.nanomixdx.com.
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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