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Chembio Diagnostics, Inc. (CEMI) is a prominent point-of-care diagnostics company dedicated to identifying and diagnosing infectious diseases. With a strong focus on conditions such as COVID-19, sexually transmitted diseases, and tropical fevers, Chembio leverages its extensive scientific expertise and pioneering DPP technology. This dual-path platform offers broad market applications that extend beyond infectious diseases, providing reliable and rapid diagnostic solutions.
Chembio operates globally, distributing its products directly and through partners to various healthcare providers, including hospitals, clinics, physician offices, and clinical laboratories. The company also collaborates with public health organizations, government bodies, and consumers to ensure widespread access to its diagnostic tools.
Recently, Chembio has been involved in significant projects that highlight its commitment to innovation. The company's novel DPP technology continues to revolutionize point-of-care testing, offering accuracy and speed that are critical for managing and controlling disease outbreaks. Financially, Chembio maintains a robust condition, with consistent revenue streams and strategic acquisitions that expand its market reach and shareholder value.
Chembio’s products are well-regarded for their quality and reliability, making them a preferred choice for healthcare professionals. The company's dedication to improving public health through rapid diagnostics positions it as a critical player in the medical field.
In the latest news, Neil A. Goldman, CPA, has joined Life Science Outsourcing, Inc. as the new CFO. His extensive experience, particularly his transformative role at Chembio Diagnostics, signifies the continued growth and strategic advancement within the life sciences sector.
Chembio Diagnostics, Inc. (CEMI) announced regulatory approval from ANVISA to market its DPP SARS-CoV-2 Antigen test in Brazil. This test detects SARS-CoV-2 antigens within 20 minutes, offering a sensitivity of 96.0% and specificity of 98.7% compared to PCR tests. Chembio aims to leverage this approval alongside its previously approved DPP COVID-19 IgM/IgG assay to enhance testing capabilities in Brazil, a key market for infectious disease diagnostics. The company plans to expand its commercial team to optimize the deployment of its growing test portfolio.
Chembio Diagnostics, Inc. (Nasdaq: CEMI) reported financial results for Q3 2020, showing total revenues of $10.3 million, a 6% increase year-over-year. Product revenue decreased 1% to $8.4 million. The company submitted EUA applications for the DPP SARS-CoV-2 Antigen and IgM/IgG test systems and received FDA PMA for the DPP HIV-Syphilis System. Despite increased revenues, the gross product margin dropped to 11.2%, attributed to lower international sales prices and operational challenges. The net loss was $5.5 million, or $0.28 per diluted share.
Chembio Diagnostics (CEMI) announced it will reveal its 2020 third-quarter financial results on November 5, 2020, after market close. A conference call with management is scheduled for 4:30 p.m. ET on the same day, where investors can participate via phone or online. Chembio focuses on point-of-care diagnostics for infectious diseases, utilizing its proprietary DPP technology for broad market applications. The company sells products globally to various healthcare organizations.
Chembio Diagnostics announced the submission for Emergency Use Authorization (EUA) of its DPP SARS-CoV-2 Antigen test system to the FDA. This rapid test can deliver results in 20 minutes and aids in detecting SARS-CoV-2 antigens with a nasal swab. The DPP platform enhances patient access to COVID-19 testing, providing both antigen and antibody testing capabilities. Chembio’s technology supports decentralized testing, reducing human error. The development was supported by federal funding. Future performance depends on regulatory approval and market adoption.
Chembio Diagnostics has received FDA approval for its DPP HIV-Syphilis System, marking the first rapid test that can diagnose both HIV and syphilis from a single patient sample. This multiplex test is designed for point-of-care and laboratory settings, providing results in just 15 minutes. With rising co-infection rates, this system is crucial for improving patient care, particularly among pregnant women and high-risk populations. The test utilizes a small blood sample and boasts a 24-month shelf life, aligning with Chembio's strategy to diversify into high-value testing areas in the U.S.
Chembio Diagnostics, Inc. (Nasdaq: CEMI) has initiated the application process for Emergency Use Authorization (EUA) for its rapid antibody test, DPP SARS-CoV-2 IgM/IgG, aimed at detecting COVID-19 antibodies. The test provides results within 15 minutes using various sample types. President Richard Eberly emphasized the urgent market need for rapid testing solutions. The DPP system is designed to enhance clinical outcomes and contribute to population surveillance. Chembio's technology aims to improve diagnostic accuracy while addressing significant healthcare demands.
Chembio Diagnostics (CEMI) will announce its 2Q 2020 financial results on August 6, 2020, after market close, followed by a conference call at 4:30 PM ET. The company's DPP technology offers rapid testing for infectious diseases, including COVID-19, and is marketed globally to various health sectors. Chembio aims to provide high-quality diagnostic results in approximately 15 minutes, expanding its market potential beyond infectious diseases.
Chembio Diagnostics (CEMI) reported preliminary revenue estimates for Q2 2020, forecasting total revenues between $4.5 million and $4.7 million, potentially increasing by $2.5 million from international product shipments. COVID-19-related sales are expected between $0.8 million and $3.3 million. This represents a significant decline from $9.9 million in Q2 2019, attributed to the pandemic's impact on sales and a shift to COVID-19 products. Cash and cash equivalents reached approximately $36.6 million, up from $11.2 million at Q1 2020, bolstered by a secondary equity raise.
Chembio Diagnostics (CEMI) announced plans to submit applications for Emergency Use Authorization (EUA) for a revised DPP COVID-19 IgM/IgG System and a new DPP COVID-19 Antigen System. The revisions follow the FDA's revocation of the EUA for the IgM/IgG System due to concerns over test performance. The new antigen system, developed using Chembio's proprietary DPP platform, aims to provide rapid COVID-19 detection at the point of care. Chembio intends to apply for an EUA for the revised IgM/IgG System in Q3 2020, highlighting the importance of timely testing in managing the pandemic.
Chembio Diagnostics (Nasdaq: CEMI) announced a $628,071 contract from BARDA to develop a COVID-19 point-of-care antigen system utilizing its proprietary DPP technology. The funding will accelerate the creation of a DPP COVID-19 Antigen Assay and DPP Micro Reader, aimed at detecting SARS-CoV-2 antigens using respiratory specimens. CEO Rick Eberly emphasized the importance of decentralizing COVID-19 testing to improve clinical outcomes. This strategic partnership marks a significant step in Chembio's efforts to combat the pandemic through rapid testing solutions.
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