Vivera Pharmaceuticals Partners with Areum Bio LLC and Access Bio, Inc. to Expand the National Distribution of Emergency Use Authorized COVID-19 Rapid Tests
June 30, 2021 at 09:00 am EDT
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Vivera Pharmaceuticals, Inc. and Areum Bio LLC announced their channel partnership to expand the distribution of Access Bio, Inc. COVID-19 Rapid Antigen Test and line of products granted FDA Emergency Use Authorization (EUA). Areum Bio is already a major distributor of New Jersey manufacturer, Access Bio'sCareStart™ COVID-19 Rapid Antigen Test, and will seek to bolster supply chain efforts through Vivera's extensive network of health care providers and organizations. As universities, businesses, airlines, and public venues integrate routine testing as a part of their return to school, work, travel, and gathering protocols, the availability of reliable COVID-19 testing remains a key necessity. The efficiency of the EUA-authorized point of care (POC) CareStart™ Rapid Antigen Test, coupled with Vivera's broad distribution capabilities, will ensure the greater ease of access to rapid diagnostic testing solutions. The U.S. has achieved major milestones in overcoming the height of the pandemic, but with lower than ideal vaccination rates and the ongoing threat of emerging variants worldwide, it remains critical that the nation continues to follow COVID-19 testing protocols to reduce viral spread. The distribution partnership between Vivera, Areum Bio, and Access Bio will help make rapid testing more readily available as quickly as possible. As an authorized distributor of the CareStart™ Rapid Antigen Test, Vivera intends to expand its outreach to ensure health care providers and patients are able to access rapid testing to help keep our communities safe. Through their strategic distribution partnership, Vivera, Areum Bio, and Access Bio hope to support the nation's safe and seamless return to normality by contributing to the increased availability of high-quality rapid testing across the country. The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Access Bio, Inc. is engaged in research, development and manufacturing of in vitro rapid diagnostic tests, biosensors and molecular diagnostic products. Its product list includes covid-19 detection kits, rapid diagnostic tests, analyzers and molecular diagnostics. Its covid-19 detection kits include CareStart COVID-19 Antigen Home Test, CareStart COVID-19 Antigen, CareStart COVID-19 MDx RT-PCR, CareStart COVID-19 lgM/lgG and CareStart EZ COVID-19 lgM/lgG. Its rapid diagnostic tests include CareStart EZ HIV, CareStart Flu A&B Plus+, CareStart G6PD RDT, CareStart Malaria RDT, CareStart Dengue RDT, care US HIV 1/2 and care US Syphilis. The analyzers include care SURE Analyzer 100, care SURE A1c Cartridge, care SURE ACR Cartridge, care SURE CRP Cartridge, care START S1 Analyzer and care START G6PD Biosensor. The molecular diagnostics include care GENE HPV Screening kit-H, care GENE Zika Virus RT-PCR kit, care GENE STD detection kit, care GENE Dengue Virus genotyping kit and others.
Vivera Pharmaceuticals Partners with Areum Bio LLC and Access Bio, Inc. to Expand the National Distribution of Emergency Use Authorized COVID-19 Rapid Tests