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Chembio Diagnostics Submits FDA De Novo/510(k) Request for DPP SARS-CoV-2 Antigen Test System

Retrieved on: 
Monday, December 6, 2021
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HAUPPAUGE, N.Y., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that it has submitted a De Novo/510(k) Request to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system.

Key Points: 
  • HAUPPAUGE, N.Y., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that it has submitted a De Novo/510(k) Request to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system.
  • BARDA support included funding for the completion of clinical studies and preparation of a De Novo/510(k) submission for the rapid DPP SARS-CoV-2 Antigen test system.
  • The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes, using a minimally invasive nasal swab and read with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Chembio Diagnostics Receives SAHPRA Approval for DPP SARS-CoV-2 Antigen Test

Retrieved on: 
Monday, November 29, 2021
Patient, Private Securities Litigation Reform Act, World Health Organization, CE marking, Jacques du Toit, Technology, Time, Hospital, PFA, Diagnosis, World, Antigen, Severe acute respiratory syndrome coronavirus 2, Infection, Blood, PMA, COVID-19, Policy, Nasdaq, ANVISA, GLOBE, Marketing, Vertically transmitted infection, SAHPRA, United, FDA, Â, DPP, U.S. Securities and Exchange Commission, Health, Discovery Health, Government, EUA, CLIA, COVID, Medical device, Pharmaceutical industry, Vaccine

We are pleased that independent evaluation of the DPP SARS-CoV-2 Antigen test again demonstrated strong sensitivity and specificity performance.

Key Points: 
  • We are pleased that independent evaluation of the DPP SARS-CoV-2 Antigen test again demonstrated strong sensitivity and specificity performance.
  • The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes.
  • The DPP SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is designed to be read visually or with a DPP Micro Reader 2 optical analyzer.
  • Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembios distributor, Patient Focus Africa, pursuant to licenses issued by SAHPRA.

Chembio Diagnostic Systems Prevails in International Arbitration Against BioSure (UK) Ltd

Retrieved on: 
Monday, November 22, 2021
Transfer, Sale, Technology, Hearing, Hospital, Diagnosis, Infection, COVID-19, Record, GLOBE, Marketing, SURE, Vertically transmitted infection, Â, DPP, Government, HIV, Pharmaceutical industry, Vaccine, Video game console

HAUPPAUGE, N.Y., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostic Systems Inc. (Chembio), a subsidiary of Chembio Diagnostics, Inc. (Nasdaq: CEMI), received an international arbitration award Thursday, November 18, 2021 against BioSure (UK) Ltd, Chembios former UK distributor of HIV self-tests.

Key Points: 
  • HAUPPAUGE, N.Y., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostic Systems Inc. (Chembio), a subsidiary of Chembio Diagnostics, Inc. (Nasdaq: CEMI), received an international arbitration award Thursday, November 18, 2021 against BioSure (UK) Ltd, Chembios former UK distributor of HIV self-tests.
  • In April 2014, Chembio and BioSure entered into a distribution agreement under which BioSure was licensed the right to sell bundled products in the UK containing Chembios SURE CHECK HIV pouched tests.
  • On September 16, 2019, Chembio initiated arbitration in New York, USA alleging BioSure breached the distribution agreement, misappropriated Chembios trade secrets, and engaged in other unlawful conduct.
  • In addition to the monetary award, BioSure has been ordered to immediately:
    Stop making, using, offering for sale, or selling the BioSure HIV Self Test.

Chembio Diagnostics Submits EUA Application for New DPP SARS-CoV-2 Antigen Test

Retrieved on: 
Tuesday, November 16, 2021
COVID-19 testing, DPP, Point-of-care testing, Government, PMA, CLIA, Infection, Antigen, ANVISA, World, Department, World Health Organization, Technology, Food, Blood, Severe acute respiratory syndrome coronavirus 2, United States Department of Health and Human Services, COVID-19, CE marking, Emergency Use Authorization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, U.S. Department of Defense Strategy for Operating in Cyberspace, Biomedical Advanced Research and Development Authority, Hospital, Office of the Assistant Secretary for Preparedness and Response, GLOBE, Development, Solution, Vertically transmitted infection, Diagnosis, EUA, Assistant, Nasdaq, Patient, FDA, Vaccine, Medical device

HAUPPAUGE, N.Y., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for the new DPP SARS-CoV-2 Antigen test.

Key Points: 
  • HAUPPAUGE, N.Y., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for the new DPP SARS-CoV-2 Antigen test.
  • The DPP SARS-CoV-2 Antigen test system has been designed to detect SARS-CoV-2 antigens in only 20 minutes.
  • The DPP SARS-CoV-2 Antigen test system is now designed to use a minimally invasive nasal swab and be read visually or with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Chembio Diagnostics Announces Extension of Delivery Schedule for Bio Manguinhos Purchase Order of DPP SARS-COV-2 Antigen Tests

Retrieved on: 
Monday, November 15, 2021
COVID-19, Private Securities Litigation Reform Act, DPP, Government, PMA, CLIA, U.S. Securities and Exchange Commission, Infection, ANVISA, World, World Health Organization, Technology, Blood, CE marking, Â, SARS-COV-2, Policy, Hospital, GLOBE, Vertically transmitted infection, Diagnosis, EUA, Patient, FDA, Vaccine, Pharmaceutical industry

HAUPPAUGE, N.Y., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that the delivery schedule for shipments of DPP SARS-COV-2 Antigen Tests under its July 2021 purchase order from Bio Manguinhos has been extended into March 2021.

Key Points: 
  • HAUPPAUGE, N.Y., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that the delivery schedule for shipments of DPP SARS-COV-2 Antigen Tests under its July 2021 purchase order from Bio Manguinhos has been extended into March 2021.
  • Chembios delivery of tests covered by the purchase order, however, continues to be negatively affected by limitations of Chembios supply chain, staffing, and liquidity, and other matters outside Chembios control.
  • The DPP SARS-CoV-2 Antigen test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in only 20 minutes using a minimally invasive nasal swab.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Chembio Diagnostics to Report Third Quarter 2021 Financial Results on November 4, 2021

Retrieved on: 
Thursday, October 21, 2021
DPP, Fever, Government, Infection, Technology, GLOBE, Hospital, COVID-19, Vaccine

HAUPPAUGE, N.Y., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, announced today that it will release financial results for the third quarter of 2021 after the close of trading on Thursday, November 4, 2021.

Key Points: 
  • HAUPPAUGE, N.Y., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, announced today that it will release financial results for the third quarter of 2021 after the close of trading on Thursday, November 4, 2021.
  • The companys management team will host a corresponding conference call beginning at 4:30 p.m. Eastern Time on November 4, 2021.
  • Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease.
  • Coupled with Chembios extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease.

Chembio Announces EUA Submission for DPP Respiratory Antigen Panel

Retrieved on: 
Wednesday, September 22, 2021
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HAUPPAUGE, N.Y., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the companys DPP Respiratory Antigen Panel test system.

Key Points: 
  • HAUPPAUGE, N.Y., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the companys DPP Respiratory Antigen Panel test system.
  • The DPP Respiratory Antigen Panel test system is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab.
  • The contract also supports preparation of a submission to the FDA in pursuit of 510(k) clearance for the DPP SARS-CoV-2 Antigen test system.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Chembio Launches Commercial Distribution of Third-Party COVID-19 Antigen Assay

Retrieved on: 
Friday, August 27, 2021
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Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States.

Key Points: 
  • Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States.
  • We are excited about the addition of this differentiated product to our menu of COVID-19 assays, said Charles Caso, Vice President of Sales and Marketing for Chembio.
  • Our expanded commercial team can now offer testing solutions for CLIA waived settings and work and school settings.
  • The SCoV-2 Ag Detect Rapid Test complements our internal development efforts on our DPP Respiratory Panel product and our DPP SARS CoV-2 Antigen assay, continued Mr. Caso.