Chembio Diagnostics Highlights Proprietary DPP Platform Enabling Rapid, Point-of-Care Infectious Disease Testing with Just a Drop of Blood

On January 10, 2020, Chembio Diagnostics’ stock price fell by more than 11%.

Chembio Diagnostics is a world-leading medical diagnostics company specializing in the detection and diagnosis of infectious diseases. The company owns the patented DPP technology platform, which delivers high-quality, low-cost test results to users within approximately 15 minutes using a single drop of blood from a finger prick.

The direct cause of the sharp plunge in Chembio’s stock price was its announcement after the market close on the 9th that John J. Sperzel III had resigned as Chief Executive Officer effective January 3 to assume the role of President and Chief Executive Officer at T2 Biosystems. The latter is an emerging leader in the field of in vitro diagnostics, with two FDA-approved products for sepsis, dedicated to saving lives and reducing healthcare costs by empowering clinicians to treat patients more effectively and rapidly than ever before.

Amidst the leadership vacuum, Chembio appointed board member and venture capitalist Gail Page as interim CEO and initiated a search for senior executives to identify a permanent CEO. Gail Page has served on Chembio’s board since 2017 and has successfully founded and operated multiple companies.

Chembio’s stock price fell due to personnel changes. Fortunately, before the market closed on the 10th, Chembio’s stock price rebounded to $4.54, with a decline of 6.6%.

Chembio Board Chair Kathy Davis stated that several key initiatives led by John J. Sperzel III enabled Chembio to sustain growth in its existing markets and expand its target markets through its proprietary, leading-edge technology platform. “Sperzel has left the company in a strong position.”

That is indeed the case.

On January 2, 2020, the day before John J. Sperzel III’s departure, Chembio submitted an update to its Premarket Approval (PMA) application for the DPP® HIV-Syphilis System to the U.S. Food and Drug Administration (FDA). The company anticipated that the FDA would approve the DPP® HIV-Syphilis System, which includes the DPP® HIV-Syphilis Test and the DPP® Micro Reader, in the first quarter of 2020.

This event has undoubtedly given Chembio a strong start to the new year. According to BCC Research’s survey of the global market share for point-of-care (POC) testing for infectious diseases in 2018, Chembio accounted for 3% of the global market. Can Chembio capitalize on this momentum? What challenges will it face along the way? We attempt to find answers by examining Chembio’s development history.

Chembio was founded in Medford, New York, in 1985, dedicated to the development, manufacturing, sales, and distribution of in vitro diagnostic tests. In 1995, Chembio began its point-of-care diagnostics business for humans and animals. Chembio currently employs nearly 300 full-time staff. Interestingly, Chembio favors recruiting graduates from National Louis University, with nearly 10% of its employees having attended this institution.

On May 5, 2004, Chembio and Chembio Diagnostic Systems completed their merger. Through this merger, Chembio Diagnostics Systems became a wholly-owned subsidiary of Chembio.

On May 26, 2005, Chembio announced the opening of its East Africa sales office. On March 23, 2006, the Nigerian Ministry of Health announced that Chembio Diagnostics’ HIV 1/2 STAT-PAK had been designated as one of four screening tests among the eight testing protocols in Nigeria’s interim national testing algorithm. Nigeria initially implemented a “parallel testing algorithm,” whereby two screening tests from different manufacturers were used for each patient undergoing testing.

Exactly one year later, the FDA approved the premarket applications (PMAs) for Chembio’s SURE CHECK® HIV 1/2 and HIV 1/2 STAT-PAK™ rapid tests. This approval enabled Chembio to deploy its rapid HIV tests in clinical laboratories and hospitals across the United States and helped expand its international sales footprint. In 2007, Chembio’s Dual Path Platform (DPP) technology was granted a U.S. patent.

In the decade that followed, Chembio Diagnostics grew quietly. It was not until January 11, 2017, when it acquired RVR Diagnostic, a Malaysian company dedicated to developing point-of-care (POC) diagnostic solutions, that Chembio’s ambitions for expansion began to emerge.

This transaction enables Chembio to acquire RVR Diagnostic’s innovative point-of-care (POC) testing expertise for human immunodeficiency virus (HIV), syphilis, and dengue fever. Following the signing of the agreement between the two companies, John Sperzel III, former CEO of Chembio, stated that Chembio plans to expand its business into Southeast Asia and other regions worldwide, with Malaysia serving as Chembio’s primary hub in Southeast Asia.

On April 4, 2017, Chembio partnered with the Foundation for Innovative New Diagnostics (FIND) in Switzerland to develop point-of-care (POC) diagnostic tests for detecting several acute febrile diseases in the Asia-Pacific region. FIND will leverage Chembio’s DPP technology to create a simple, rapid, and cost-effective testing method.

On December 19, 2017, Chembio partnered with AstraZeneca to develop point-of-care (POC) diagnostic tests for eosinophilic respiratory diseases; on the 27th of the same month, Chembio announced that it had secured a conditional Long-Term Agreement (LTA) with UNICEF for the purchase of the company’s DPP Zika/Chikungunya/Dengue test devices.

On April 25, 2018, Chembio partnered with LumiraDx to develop point-of-care (POC) diagnostic tests for infectious diseases. On October 22 of the same year, it acquired opTricon GmbH, an original equipment manufacturer (OEM) based in Berlin, for $5.5 million in cash.

In 2019, Chembio was highly active. On April 2, Chembio partnered with Perseus Science to accelerate the development of diagnostic tests for mild traumatic brain injury (TBI) or concussion. On July 18, it collaborated with Shire Human Genetic Therapies, a subsidiary of Takeda Pharmaceutical Company, to develop a diagnostic test targeting unknown biomarkers by leveraging its DPP® Chromatographic Immunoassay and handheld optical reader.

On November 25, 2019, Chembio completed the acquisition of Orangelife Comercio e Industria Ltda, based in Brazil. John Sperzel, former CEO of Chembio, stated, “The acquisition of Orangelife strengthens our operations in Brazil, strategically expanding our commercial footprint. We consider Brazil to be one of the most attractive markets for infectious disease testing worldwide.”

Chembio currently has two product lines: rapid point-of-care (POC) testing for human infectious diseases and rapid POC testing for animal health. In the human diagnostics market, Chembio focuses on HIV. Its initial lateral flow (LF) rapid HIV test product line remains widely used today, including the HIV 1/2 STAT-PAK® test, the HIV 1/2 STAT-PAK® Dipstick test, and the SURE CHECK® HIV 1/2 Rapid Test. Chembio’s animal POC product line includes tests for animal tuberculosis and leishmaniasis; this product line will not be discussed in detail in this article.

Lateral Flow (LF) Technology

HIV 1/2 STAT-PAK Test: This is a single-use rapid diagnostic test (15 minutes) for the detection of HIV-1 and HIV-2 antibodies at the point of care (POC), suitable for serum, plasma, fingerstick whole blood, and venipuncture whole blood.

HIV 1/2 STAT-PAK Rapid Test: This assay is suitable for point-of-care testing, requiring no specialized laboratory equipment. The single-use diagnostic device provides rapid and visual detection of antibodies to HIV-1 and HIV-2.

SURECHECK HIV 1/2 Rapid Test: This assay integrates sample collection and the testing device into a single unit. Each test kit includes a sterile lancet, bandage, and stand. The two-step testing procedure has received FDA approval.

Dual-Path Platform (DPP) Technology

Chembio’s DPP technology, which was granted a U.S. patent in 2007, serves as a critical technological foundation for its products. This innovative immunochromatographic assay uses a single drop of capillary blood from a fingerstick to deliver high-quality, low-cost results in approximately 15 minutes, enabling rapid, point-of-care diagnostic testing for a wide variety of analytes. Compared with lateral flow (LF) technology, this platform offers distinct advantages.

DPP® HIV-Syphilis Assay: The first HIV-1/2 and syphilis point-of-care (POC) dual test kit developed by Chembio using its DPP technology. The Chembio DPP HIV-Syphilis Assay is a single-use immunochromatographic rapid test for the detection of antibodies to human immunodeficiency virus types 1 and 2 (HIV-1/2) and Treponema pallidum (the causative agent of syphilis) in fingerstick whole blood, venous whole blood, serum, and plasma.

The Chembio DPP HIV-Syphilis Test is intended as a point-of-care test to aid in the diagnosis of HIV and/or syphilis infection. This assay is suitable for multi-test algorithms designed for statistical validation of rapid HIV test results. A unique feature of this kit is Chembio’s novel DPP SampleTainer vial, which contains pre-measured diluent buffer and serves as a dropper for testing while remaining in its sealed vial.

DPP Zika IgM System: This kit is used to detect Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma, and serum, with results available in 15 minutes. The test has received FDA Emergency Use Authorization (EUA) for laboratory use and is authorized solely for the diagnosis of Zika virus infection, not for any other viruses or pathogens.

DPP Zika IgM/IgG System: This is a disposable point-of-care (POC) test used in conjunction with the DPP Micro Reader for the differential and semi-quantitative detection of Zika virus immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. It is CE-marked.

DPP HIV 1/2 Oral Fluid or Blood Test: Chembio’s next-generation rapid test for HIV-1 and HIV-2 antibodies, utilizing patented DPP assay technology, is suitable for use with oral fluid and all blood matrices.

POCT is the fastest-growing subsector within the IVD industry over the past two decades. According to data from Rncos and China Merchants Securities, the global POCT market size reached approximately USD 17.5 billion in 2018, accounting for about 30% of the IVD market. In contrast, China’s POCT market was only around USD 1.4 billion in 2018, representing approximately 11% of its IVD market, a significantly lower proportion. More than half of the domestic POCT market share is held by imported brands.

Against this backdrop, many domestic companies are gearing up to compete head-to-head with imported products using their own offerings.

On July 10, 2018, Mingde Biology was officially listed on the Shenzhen Stock Exchange, becoming the third A-share diagnostic reagent company with POCT as its core business, following Wondfo Biotech and Getein Biotech. After a decade of dedicated development, Mingde Biology, founded in 2008, has now entered the first tier of the POCT industry.

Mingde Biology has achieved multiple technological innovations and breakthroughs in the field of POCT rapid diagnostic reagents, mastering technologies such as whole blood filtration, multiplex antibody labeling, and colloidal gold preparation. Leveraging these capabilities, the company has established a POCT reagent R&D platform, with its product portfolio covering over 20 categories of disease testing across six major areas: infectious diseases, cardiovascular and cerebrovascular diseases, renal diseases, diabetes, obstetrics and gynecology (eugenics and healthy reproduction), and health check-ups.

In addition to the three listed POCT companies mentioned above, Lepu Medical is also a representative domestic enterprise. On November 19, 2018, the “AI-ECG Platform,” an AI-powered automated ECG analysis and diagnostic system independently developed by a subsidiary of Lepu Medical, received FDA registration approval, becoming the first AI-based ECG product from China to be approved by the U.S. FDA. On February 6, 2020, the product obtained registration approval from the NMPA (National Medical Products Administration), making it the only AI-based ECG diagnostic product in China to have secured approvals from the NMPA, the U.S. FDA, and the EU CE marking.

As Chinese enterprises continue to advance their technological capabilities in the POCT sector, they are also actively strategizing for overseas market expansion.

Founded in 2014, Huamai Xingwei specializes in the fields of microfluidics and POCT chemiluminescence. After years of accumulation, the company has launched the Aurora series clinical product line, the Tianji series testing product line, and a bulk-reagent OEM product line. Among these, the clinical product line has been adopted by more than 100 medical institutions across China, the majority of which are Grade III Class A hospitals. Furthermore, all three major product lines have obtained CE certification, marking the company’s expansion into international markets. On July 1, 2019, Huamai Xingwei completed a Series B financing round worth tens of millions of RMB to broaden its product portfolio, break through market barriers, and build a POCT-based health management platform.

Having secured multiple market access certifications for European and American markets, including FDA, CE, ISO 13485, and ISO 15197:2013, within just two years of its establishment, Vazyme Biotech is rooted in blood glucose monitoring, the largest segment of the POCT market, and is committed to becoming a global leader in the POCT field. Its blood glucose monitoring products have been included in the UK National Health Service (NHS) treatment catalog, allowing for unrestricted distribution within the NHS system. Currently, Vazyme Biotech’s POCT products are sold in over 70 countries, including Germany, Italy, the UK, and the US, and have been listed in the treatment catalogs of major European healthcare insurance markets. As one of China’s largest POCT exporters to Europe, the company has an annual production capacity of 500 million test strips.

Source:

https://www.mg21.com/cemi.html

http://chembio.com/products/human-diagnostics/