Chembio Diagnostics

Chembio Diagnostics, Inc. engages in the developing, manufacturing, marketing, and licensing of rapid medical tests. It offers rapid point-of-care tests for infectious, tropical and fever, and respiratory diseases, handheld analyzers, and veterinary products. The firm distributes its products to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. The company was founded in 1985 and is headquartered in Hauppauge, NY.

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Chembio Diagnostics, Inc. engages in the developing, manufacturing, marketing, and licensing of rapid medical tests. It offers rapid point-of-care tests for infectious, tropical and fever, and respiratory diseases, handheld analyzers, and veterinary products. The firm distributes its products to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. The company was founded in 1985 and is headquartered in Medford, NY.

Chembio Diagnostics stock collapsed Wednesday after the Food and Drug Administration revoked emergency use authorization for its antibody coronavirus test due to accuracy concerns.

Covid Report: Medtech Crashes 60% After FDA Revokes Its Coronavirus Test

Shares of Chembio Diagnostics Inc (NASDAQ: CEMI), which rallied nicely following the launch of its rapid DPP COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies in late March, are pulling back sharply Wednesday.

Chembio's Stock Craters After Coronavirus Antibody Test Emergency Use Is Revoked

HAUPPAUGE, N.Y., June  08, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the DPP Zika IgM System.

Chembio Diagnostics Receives FDA 510(k) Clearance for DPP Zika IgM System

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HAUPPAUGE, N.Y., May  11, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI) (“Chembio”), a leading point-of-care diagnostic company focused on infectious diseases, announced today the closing of its previously announced public offering of 2,619,593 shares of its common stock, which included 281,125 shares issued pursuant to the partial exercise by the underwriters of their option to purchase additional shares, at a public offering price of $11.75 per share for gross proceeds of approximately $30.8 million. All shares of common stock sold in the offering were offered by Chembio.

Chembio Diagnostics Announces Closing of Public Offering of Common Stock

HAUPPAUGE, N.Y., May  07, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI) (“Chembio”), a leading point-of-care diagnostic company focused on infectious diseases, announced today the pricing of its previously announced public offering of 2,338,468 shares of its common stock at a public offering price of $11.75 per share for gross proceeds of approximately $27.5 million. In addition, Chembio has granted the underwriters a 30-day option to purchase up to an additional 350,770 shares of common stock at the public offering price less the underwriting discounts and commissions. All shares of common stock to be sold in the offering will be offered by Chembio. The offering is expected to close on or about May 11, 2020, subject to the satisfaction of customary closing conditions.

Chembio Diagnostics Announces Pricing of Public Offering of Common Stock

HAUPPAUGE, N.Y., May  06, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI) (“Chembio”), a leading point-of-care diagnostic company focused on infectious diseases, announced today a proposed public offering of an undetermined number of shares of its common stock. All shares of common stock to be sold in the proposed offering will be offered by Chembio. In addition, Chembio expects to grant the underwriters a 30-day option to purchase additional shares, in a number equal to up to 15% of the number of shares of common stock sold in the proposed offering, at the public offering price less the underwriting discounts and commissions. The proposed offering is subject to market and other conditions, as well as customary closing conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the size or other terms thereof.

Chembio Diagnostics Announces Proposed Public Offering of Common Stock

Chembio Diagnostics, Inc. (CEMI) CEO Rick Eberly on Q1 2020 Results - Earnings Call Transcript

HAUPPAUGE, N.Y., May  04, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced it has attained the CE Marking for its DPP COVID-19 System. The CE Marking represents the ability to commercialize the system within the member states of the European Union and the Caribbean region, except for Puerto Rico.

Chembio Diagnostics Attains CE Marking for DPP COVID-19 System for IgG and IgM Antibodies

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Chembio (CEMI) saw a big move last session, as its shares jumped more than 7% on the day, amid huge volumes.

Chembio (CEMI) Jumps: Stock Rises 7.1%

First Shipments of the COVID-19 Serological Test have been Released

Chembio Diagnostics Receives Emergency Use Authorization for DPP COVID-19 System for IgG and IgM Antibodies

Features the Multiplex Zika, Chikungunya, Dengue System Features the Multiplex Zika, Chikungunya, Dengue System

Chembio Receives Second UNICEF Order for $1.5 Million

IgM/IgG Antibody Results in 15 Minutes from a Simple Finger Stick IgM/IgG Antibody Results in 15 Minutes from a Simple Finger Stick

Chembio Announces Launch of DPP COVID-19 Serological Point-of-Care Test

HAUPPAUGE, N.Y., March  20, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced its receipt of a $4 million order from Bio-Manguinhos for the purchase of Chembio’s DPP COVID-19 IgM/IgG System, to support the urgent needs of Brazil’s Ministry of Health. Bio-Manguinhos is a subsidiary of the Oswaldo Cruz Foundation (Fiocruz) that is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. Chembio has a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of HIV and other infectious diseases. Chembio’s Brazilian subsidiary has filed for ANVISA approval of the DPP COVID-19 IgM/IgG System under the emergency use authorization program.

Chembio Diagnostics Receives $4 Million Purchase Order from Bio-Manguinhos for Production of DPP COVID-19 IgM/IgG System in Brazil

Chembio Diagnostics, Inc. (CEMI) Management on Q4 2019 Results - Earnings Call Transcript

HAUPPAGE, N.Y., March  12, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the appointment of Richard Eberly as its President and Chief Executive Officer effective March 16, 2020. Mr. Eberly also will be a director nominee for election at Chembio’s 2020 Annual Meeting of Stockholders. Gail Page, a Chembio director who has served as Chembio’s Interim CEO since early January 2020, will assume an active advisory role for ninety days to assist in the leadership transition.

Chembio Diagnostics Appoints Richard Eberly As Chief Executive Officer

MEDFORD, N.Y., March  03, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, is providing an update on the FDA Premarket Approval (PMA) application for Chembio’s DPP HIV-Syphilis Assay System. The FDA has confirmed that, of the items that had been open for the PMA review, the Syphilis arm of the study was acceptable, as were the results as they relate to the inclusion of pregnant women. As indicated by the FDA on February 21, 2020, the only remaining item requested of the company is to repeat the reproducibility study, as one of the sites in the trial reported greater variability compared to the other sites. Chembio has both addressed and discussed with the FDA what it deems to be the underlying cause of the variance, and it has already initiated the reproducibility study required by the FDA. In parallel, the company has accelerated the studies for a CLIA waiver, which can be submitted upon FDA approval of the PMA application. These efforts reflect the company’s continuing focus on both the achievement of the PMA milestone and the timing of ultimate approval with the CLIA waiver.

Chembio Diagnostics Provides Update on Regulatory Status of DPP HIV-Syphilis System

MEDFORD, N.Y., Feb.  12, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced a $1.5 million purchase order from UNICEF for multiplex Zika tests and Micro Readers following the successful completion of conditions set forth in the previously announced long term arrangement (LTA). This initial order is part of the LTA, which has a total opportunity of up to $3.5 million.

Chembio Diagnostics Receives $1.5 Million UNICEF Order for Multiplex Zika Systems

MEDFORD, N.Y., Jan.  09, 2020  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced President and Chief Executive Officer John Sperzel has resigned for another opportunity. The Chembio Board of Directors has appointed Director Gail Page as Interim CEO and initiated an executive search process to identify a permanent CEO.

Chembio Diagnostics Announces CEO Transition

Anticipates FDA Approval of Multiplex Test and Micro Reader During Q1 2020 Anticipates FDA Approval of Multiplex Test and Micro Reader During Q1 2020

Chembio Diagnostics Provides Update on FDA Submission of DPP HIV-Syphilis Test

MEDFORD, N.Y., Nov.  25, 2019  (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that it has completed its previously announced acquisition of Orangelife Comercio e Industria Ltda., a Brazilian manufacturer and distributor of point-of-care diagnostics tests for infectious diseases.

Chembio Diagnostics Completes Acquisition of Orangelife

Chembio Diagnostics, Inc. (CEMI) CEO John Sperzel on Q3 2019 Results - Earnings Call Transcript

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