May 17, 2022 | Source: GlobeNewswire
HAUPPAUGE, N.Y., May 17, 2022 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced it has entered into a manufacturing agreement with Reszon Diagnostics International Sdn. Bhd. (Reszon) to produce Chembio’s HIV 1/2 STAT-PAK Assay products in the Chembio Diagnostics Malaysia (CDM) facility. CDM had previously suspended operations in May 2020.
This new manufacturing arrangement will leverage CDM’s product and facility qualification by the World Health Organization Prequalification Program and ISO 13485 certification. The relationship will also combine Chembio’s manufacturing abilities with Reszon’s resources and manufacturing strengths in the diagnostics space. Operations are planned to commence in the third quarter of 2022 dependent on reaching certain quality, production and other targets.
“We are excited to be working with Reszon, a leader in Malaysian diagnostics test kits, to optimize our global manufacturing by leveraging our Malaysian resources. This represents a major milestone in our Global Competitiveness Program to improve profitability,” said Richard Eberly, Chembio’s Chief Executive Officer and President. “We believe this new relationship will increase our capacity to supply new markets, bolster our competitiveness and strengthen our position in rapid point-of-care testing. We look forward to exploring commercial opportunities in Malaysia and other high-growth markets.”
“Chembio offers best-in-class technology, and we are confident we can significantly scale manufacturing of their tests,” said EL Law, Reszon’s Chief Executive Officer. “We are eager to work with the entire Chembio team and expand our business in the Malaysian and international markets. We see this as an excellent opportunity for both parties to leverage our individual strengths. We feel this can take us both to the next level of commercial success and look forward to a long and mutually beneficial relationship.”
About Chembio Diagnostics
Chembio is a leading diagnostics company focused on developing and commercializing point-of-care tests used to detect and diagnose infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.
About Reszon Diagnostics International
Established since 2010, Reszon develops and manufactures a strong portfolio of innovative in vitro diagnostics (IVD) rapid tests and ELISA kits for medical professionals, including clinical diagnostic markets worldwide. Reszon’s IVD rapid test kits allow medical professionals to diagnose diseases quickly and accurately for the early detection and prevention of diseases. The easy to use and portability of its rapid test kits make them ideal for use in wide range of settings, including remote areas and countries where sophisticated medical diagnostics are not available. Reszon has supplied over 20 million tests in South East Asia making it the largest regional supplier of Covid Self Testing Kits. Reszon is actively transforming its manufacturing process to full automation in order to competitively address growing global needs. Reszon is also committed to providing the best affordable diagnostics in the self-testing sector.
Certain statements contained in the second and third paragraphs above are not historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the timing and operational and financial success of Chembio’s agreement with Reszon. Such statements, which are expectations only, reflect management’s current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events or performance may differ materially from forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the following, any of which could be exacerbated even further by the continuing COVID-19 outbreak in the United States, Malaysia and globally: Chembio’s ability to receive and sell products contemplated by the agreement could be materially constrained by global events, including continuing COVID-19 outbreaks and the armed conflict in Ukraine, leading to transportation delays, logistics disruptions and supply chain limitations that could materially adversely affect the ability of Reszon to manufacture products under the agreement; Chembio and Reszon may encounter regulatory or other delays in commencing manufacturing under the agreement, many of which may be outside the control of Chembio; Chembio may be unable to manage and monitor manufacturing at the CDM facility to ensure product compliance with applicable requirements of the World Health Organization and international regulators; potential customers may not adopt or require products produced under the agreement to the extent expected by Chembio; Chembio’s operational and financial success under the agreement depends significantly upon the efforts of Reszon, and Chembio has limited experience in outsourcing manufacturing and no experience in outsourcing manufacturing to Reszon; and there can be no assurance that the manufacturing operations contemplated by the agreement will be extended beyond the initial orders of a specified number of HIV 1/2 STAT-PAK Assay products. Chembio undertakes no obligation to publicly update forward-looking statements in this release to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio’s expectations with regard to the forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio’s success are more fully disclosed in Chembio’s periodic public filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, particularly under the heading “Risk Factors.”
DPP is Chembio’s registered trademark, and the Chembio logo is Chembio’s trademark. For convenience, these trademarks appear in this release without ® or ™ symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademarks.