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Chembio Diagnostics, Inc. (CEMI) delivers rapid diagnostic solutions through its proprietary DPP technology, serving healthcare providers and public health organizations worldwide. This dedicated news hub provides investors and industry professionals with essential updates on financial developments, product innovations, and strategic partnerships.
Access real-time press releases covering earnings reports, regulatory milestones, and leadership changes, including recent executive appointments impacting the diagnostics sector. Discover updates on Chembio's expanding portfolio of infectious disease tests for COVID-19, tropical fevers, and STDs, all critical tools for modern healthcare systems.
Our curated news collection enables informed decision-making by tracking operational expansions, technology licensing agreements, and collaborations with global health authorities. Bookmark this page for direct access to verified updates about Chembio's market position and contributions to point-of-care diagnostics.
Chembio Diagnostics, Inc. (Nasdaq: CEMI) recently received a CLIA waiver from the FDA for its DPP HIV-Syphilis System, allowing use in over 200,000 CLIA-waived testing sites in the U.S. This test can significantly improve the rapid diagnosis of HIV and syphilis, both of which have seen rising rates according to CDC data. The DPP system offers a 15-minute result using a small blood sample and provides critical data for managing syphilis and HIV infections. The test aims to reduce mother-to-child transmission rates and improve overall community health. Chembio's technology is supported by multiple regulatory approvals worldwide.
Biosynex has entered a definitive merger agreement to acquire Chembio Diagnostics for $0.45 per share, a 27% premium over Chembio’s closing price on January 30, 2023, valuing the deal at $17.2 million. This acquisition aims to enhance Biosynex’s rapid diagnostic test offerings by integrating Chembio's innovative platforms focused on infectious diseases. The combined entity expects significant cost synergies through consolidated operations, broadening market reach in regions like the U.S., Brazil, Africa, and Asia. The transaction, anticipated to close in Q1 2023, was unanimously approved by both companies' Boards of Directors.
Chembio Diagnostics, Inc. (CEMI) has submitted a Clinical Laboratory Improvement Amendments (CLIA) waiver application for its DPP HIV-Syphilis System to the FDA. This innovative system enables rapid testing for HIV and syphilis on-site, providing results in just 15 minutes. The DPP platform uses a small blood sample and aims to enhance testing capabilities, especially in light of rising co-infection rates. The company anticipates that receiving the CLIA waiver will significantly improve the accessibility of testing for sexually transmitted infections.
Chembio Diagnostics, Inc. (CEMI) reported third quarter 2022 total revenue of $11.2 million, a 7% decline year-over-year. Product revenue reached $10.8 million, up 16% from last year, with a notable 361% increase in U.S. product sales. The company secured a $3.2 million CDC contract for the DPP Syphilis assay and launched its HIV self-test on Amazon in Brazil and the U.K. Despite revenue growth, net loss widened to ($6.7 million) or ($0.21) per diluted share, with cash reserves decreasing to $21.1 million. R&D expenses decreased by 46%.
Chembio Diagnostics, Inc. (CEMI) will release its financial results for Q3 2022 on November 3, 2022, after market close. A conference call will follow at 4:30 p.m. ET, accessible via phone or online. Chembio specializes in point-of-care diagnostics for infectious diseases, including COVID-19 and STDs, utilizing its innovative DPP technology. The company's products serve a global market, including hospitals, clinics, and public health organizations.
Chembio Diagnostics (CEMI) announced a $3.2 million contract with the CDC to develop a rapid point-of-care test for syphilis, utilizing its Dual Path Platform technology. The test aims to detect treponemal and nontreponemal antibodies using only 10 µL of blood with results in under 20 minutes. This initiative builds on Chembio's expertise in rapid diagnostics, following their success with the DPP HIV-Syphilis Assay. The increasing rates of syphilis underscore the need for timely diagnosis and treatment, particularly in high-risk groups and pregnant individuals.
Chembio Diagnostics (CEMI) announced plans to develop a rapid point-of-care test for monkeypox. The company is assessing the technical, regulatory, and financial aspects of this potential product while communicating with health organizations. With over 11,000 confirmed cases in the U.S., there is a growing need for faster testing solutions. Chembio's proprietary DPP technology has proven effective in previous outbreaks, including Zika and Ebola. Current monkeypox tests are PCR-based, which may not offer the rapid results required for effective management of the disease.
Chembio Diagnostics, Inc. (CEMI) reported a strong second quarter for 2022 with total revenue of $9.2 million, marking a 42% increase year-over-year. Product revenue surged to $8.9 million, a 125% growth, driven by a 208% rise in U.S. product revenue and a 114% increase in Africa. The company improved cash usage significantly, reducing cash burn to $1.6 million. Despite a net loss of ($6.9) million, the overall financial health showed progress with a gross product margin of 9% compared to negative margins in the previous year.
Chembio Diagnostics, Inc. (CEMI) will release its Q2 2022 financial results on August 4, 2022, after trading hours. The conference call for discussion will begin at 4:30 p.m. Eastern Time on the same day. Interested investors can access the call via phone or online. Chembio specializes in point-of-care diagnostics, particularly in infectious diseases, leveraging innovative DPP technology to enhance testing capabilities. The company's products are utilized globally across various healthcare settings.
Chembio Diagnostics has announced the launch of its SCoV-2 Ag Detect Self-Test in the U.S. and the expansion of its SURE CHECK HIV Self-Test distribution in Brazil and the U.K. The SCoV-2 Ag Detect Self-Test is a rapid antigen test for SARS-CoV-2, requiring no instrumentation and providing results in 20 minutes. The SURE CHECK HIV Self-Test will be available through e-commerce platforms in both countries starting in July. This expansion aims to increase patient access to home diagnostics and aligns with the company’s focus on higher-margin business opportunities.