BD Announces Streamlined Reporting Capabilities for COVID-19 Data

IndustryPRWire -- BD announced new reporting capabilities for COVID-19 data, enabling scheduled reports to be generated from BD Synapsys™ Informatics (version 3.84).

BD Synapsys™ Informatics is an optional integrated informatics solution available to customers using the BD Veritor™ Plus System, a portable instrument delivering SARS-CoV-2 antigen test results in approximately 15 minutes, and the BD MAX™ System, a molecular diagnostic platform returning results in two to three hours.

Both BD Veritor™ and BD MAX™ systems have been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to perform SARS-CoV-2 diagnostic testing.

The BD Synapsys™ solution's new capabilities allow global customers to create general-purpose reports with COVID-19 data from their BD Veritor™ and/or BD MAX™ systems. The solution also offers configured reporting capabilities, which allow customers in the U.S. to generate reports in accordance with the U.S. Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act requires COVID-19 testing facilities to report testing data to local and federal health authorities daily, including the number of tests performed, results and key patient demographics. Additional configured reports can be developed, as needed.

Rajeev Sehgal, director of Informatics for BD Integrated Diagnostics Solutions Commented "BD Synapsys™ Informatics unifies instrument-read COVID-19 test results from the BD Veritor™ and BD MAX™ systems, The solution's new encrypted reporting capabilities reduce the burden associated with manual reporting. This empowers customers to focus on what matters most: Caring for their patients."

Used with the BD Veritor™ Plus System and/or the BD Max™ System, the BD Synapsys™ Informatics 3.84 solution allows customers to export all SARS-CoV-2 test results in a single daily report.

Troy Hopps, business group leader of point of care diagnostics for BD Commented "Timely, accurate reporting allows public health officials to monitor the spread of COVID-19, For COVID-19 testing facilities – including labs, hospitals and nursing homes – the BD Synapsys™ Informatics solution's new reporting capabilities, supported by secure connectivity, simplifies the process of reporting test results to public health authorities."

About BD Synapsys™ Informatics

BD Synapsys™ Informatics is the informatics platform for BD diagnostics systems, including the BD Veritor™ Plus System and the BD MAX™ System, which have been granted Emergency Use Authorization by the U.S. Food and Drug Administration to perform SARS-CoV-2 diagnostic testing. BD Synapsys™ Informatics solution provides secure connectivity, integrated workflows, and on-demand actionable insights for laboratories and facilities with Clinical Laboratory Improvement Amendments (CLIA) waivers. BD Synapsys Informatics was among the first life science diagnostics informatics platforms to receive the Underwriters Laboratory Cybersecurity Assurance Program certification, an independent third-party evaluation that uses standardized, testable criteria for assessing software vulnerabilities and weaknesses. 

About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay

The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has been CE marked to the IVD Directive (98/79/EC), but has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use.

About the BD MAX™ System for Detection of SARS-CoV-2 Assay

The BD SARS-CoV-2 Reagent Kit for BD MAX™ System has been CE marked to the IVD Directive (98/79/EC), but it has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection. It has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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