ChemBio Diagnostics Systems, Inc.
They enable longer and healthier living through detection and monitoring of serious disease
At Chembio, their mission is to be a leader in the development, manufacture and commercialization of diagnostic solutions. They are dedicated to delivering exceptional products that provide ease of use, and rapid and accurate results at the point-of-care (POC). As a global company, they are committed to innovation and the highest quality standards.
At the core of their commitment is their patented Next Generation DPP® (Dual Path Platform) technology. Their DPP® technology is a breakthrough in POC diagnostics, offering significant advantages over lateral-flow technologies including:
- Significantly improved sensitivity
- Multiplexing – multiple test results via a single blood sample (e.g., HIV-Syphilis Assay)
- Application in a number of indications
Today their DPP® technology is the basis of multiple collaborations with healthcare innovators and leaders worldwide spanning infectious diseases such as HIV, Zika, Ebola, syphilis, malaria and febrile illness, as well as potential new uses in the diagnosis of a specific form of cancer and brain injury (concussion).
Chembio’s core strengths are in its quality, product development, manufacturing and commercialization expertise.
In particular, Chembio’s quality standards distinguish them within the industry. They are committed to providing quality products that meet or exceed the needs of their customers. Quality is built into all steps of their process from design, manufacture, testing, release, and delivery through to customer service.
This focus on quality has shaped their product development and manufacturing processes. All of their products meet the highest standards of safety, reliability and effectiveness, and all are manufactured by Chembio at their state-of-the art production facility, which is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Organization for Standardization, ISO 13485, the standard for quality management systems in the medical device industry.
To effectively commercialize our products, Chembio has established a sales and marketing infrastructure led by a team of seasoned and successful professionals to expand their current markets and penetrate new markets worldwide.
In December 2016 Chembio completed the acquisition of RVR Diagnostics Sdn Bhd a Kuala Lumpur, Malaysia manufacturer of rapid diagnostic products. RVR is now a full manufacturing, supply and center of excellence facility of Chembio producing both RVR and Chembio products to serve the Asia markets.
PRODUCTS AND PARTNERSHIPS
Chembio has products on the market in over 40 countries primarily for the rapid and early detection of HIV and syphilis. Chembio markets its SURE CHECK®HIV 1/2, DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assay in the U.S. through its direct sales force and through distributors. Outside the U.S., Chembio markets its DPP® HIV 1/2, HIV 1/2 STAT-PAK®, Chagas STAT-PAK®, DPP® HIV-Syphilis, SURE CHECK® HIV 1/2 and STAT-VIEW® HIV 1/2 Assays primarily through distributors.
Equally important, Chembio has a strong development pipeline that they believe will serve as a significant growth driver in the future. Their internal development effort is currently focused on next generation diagnostics for multiplex HIV-syphilis combination testing and its fever disease portfolio including single and multiplex tests for Zika, chikungunya and dengue.
In addition, Chembio is a party to multiple collaborations, all of which seek to develop new and innovative products to address some of the world’s most serious diseases and conditions. Based on the power and versatility of their DPP® technology, they are working with their partners to develop next generation products that they hope will enable early and improved treatment of malaria, Ebola, febrile illness, dengue fever and influenza. Beyond infectious disease, they are now demonstrating the potential utility of the DPP® platform in traumatic brain injury and in a specific form of cancer.
Together, they believe their DPP® technology, existing products, internal development expertise and global partnerships create a strong platform for innovation to improve today’s testing and treatment paradigms for the betterment of healthcare everywhere.
CHEMBIO’S STRATEGY AND FUTURE
Chembio’s mission, products and partnerships form the cornerstone of the company’s three-pronged strategic plan:
- Expand their product pipeline with high-value diagnostics for which there is significant need
- Establish an effective and wide-reaching commercialization organization to deliver their products to patients worldwide
- Leverage their technology and their global partnerships to build an infrastructure that will sustain future growth and strengthen the Chembio brand
With their DPP® platform, their exceptional scientific and commercialization personnel, and world class partners, Chembio is positioned to be a true leader in diagnostic solutions and improve healthcare around the world through early, rapid and innovative testingSee more