NEWPORT BEACH, Calif. – Vivera Pharmaceuticals, Inc. and diagnostic testing distributor, Areum Bio LLC, today announce their channel partnership to expand the distribution of Access Bio, Inc.’s CareStart™ 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’s CareStart™ 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.
“This co-branded collaboration marks a new strategic alliance for Vivera,” said Paul Edalat, Chairman and CEO of Vivera Pharmaceuticals. “The Company is proud to partner with Areum Bio and Access Bio to provide the health care organizations and patients we serve nationwide with a fast and reliable EUA-authorized COVID-19 test. By expanding access to testing, Vivera will ensure that measurable outcomes are achievable for our partners and patients and especially for the vulnerable communities that rely on us most.”
“This is a great opportunity for Areum Bio to partner with Vivera, a reputable pharmaceutical company, for the nationwide distribution of the CareStart™ COVID-19 Rapid Antigen Tests,” said Dr. Jong Kim, President of Areum Bio. “Utilizing our shared passion and areas of expertise through this partnership, we will be able to deliver rapid and reliable test kits to communities nationwide in a more timely and efficient manner. We believe that even the most innovative medical devices are of no value unless they are dispensed to the patients who need them. At Areum Bio, it is our firm belief that we only succeed when our innovative devices reach the patients and providers and serve their purposes. For this reason, we always work diligently to deliver our products to our customers in a quick, effective manner.”
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.
About CareStart™ COVID-19 Rapid Antigen Test
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.
About Vivera Pharmaceuticals, Inc.
Vivera Pharmaceuticals, Inc. is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and owns its own patents on ZICOH®, a controlled, medication dispensing device. In addition to its pharmaceutical, neurosciences, medical device, and medical technology divisions, the Company provides testing solutions through its advanced diagnostics division. Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.
Contact: Megan Kay
About Areum Bio, LLC
Areum Bio, LLC is a reliable medical device distributor that has a trustworthy partnership with Access Bio, Inc. Areum Bio is a subsidiary of Ivy Pharma Inc. based in New Jersey, which has collaborated with many business partners and has built distribution channels worldwide in addition to its 15-year distribution history in the U.S. To assist during the pandemic, Areum Bio stepped up to aid with the prompt distribution of reliable coronavirus test kits through its broad network. The Company is dedicated to constantly promoting public health and the well-being of humans by providing accurate and reliable diagnostic test kits in a timely manner.
About Access Bio, Inc.
Access Bio, Inc. is a reputable diagnostic manufacturer based in New Jersey that remains focused on the research, development, and production of diagnostics for infectious diseases. Access Bio is dedicated to the prevention and early diagnosis of infectious diseases through the research, development, and manufacturing of in vitro rapid diagnostic tests, biosensor, and molecular diagnostic products. Based on the greatest needs and the potential to do the most good, the Company works with partners across the world, including the Bill and Melinda Gates Foundation, the World Health Organization, UNICEF, and many others.