EMERYVILLE, Calif.–(BUSINESS WIRE)–Nanomix Corporation (OTCBB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced the Company has resubmitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its eLab COVID-19 rapid antigen test. The application includes additional analytical and clinical development documentation in response to FDA review comments.
The COVID-19 Antigen test cartridge is used with the Nanomix eLab Analyzer to provide electronically available results in 15 minutes.
“We look forward to the FDA’s review of our application and are proud of the work our team has done to develop a rapid, portable COVID-19 antigen test during this critical time,” stated David Ludvigson, President and Chief Executive Officer of Nanomix. “If authorized by the FDA, we believe our mobile point-of-care system will greatly increase accessibility to COVID-19 testing.”
About the Nanōmix eLab® COVID-19 Rapid Antigen Test cartridge
The Nanomix COVID-19 Rapid Antigen Test provides qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal (anterior nares) swabs. Nasal swab samples are collected using a provided swab and sample collection tube and then transferred to the single-use, microfluidic cartridge. The cartridge is run on the Nanomix eLab Analyzer which displays results in 15 minutes with the ability to print or send results electronically via Bluetooth. Additionally, the eLab system can publish Nanomix eLab COVID-19 Rapid Antigen Test results output as a QR code for privacy.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00060.
About Nanomix Corporation
Nanomix is developing mobile point-of-care diagnostics with its Nanomix eLab® 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.nano.com.
Nanomix eLab is a registered trademark.
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.