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06/30/2021

BGI announces strategic partnership with Advaite in the US, and launches a diagnostics partnership forum



Collaboration between two biotech companies signals BGI’s increased focus on fostering partnerships with organizations in the diagnostics space

CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) — BGI Americas, a global leader in diagnostic testing, today announced a partnership with Advaite, a Pennsylvania-headquartered biotech company, as well as the launch of dxpartnerships.com, a hub for diagnostics companies seeking partnerships through licensing, original equipment manufacturer (OEM) or distribution agreements.

The partnership will add Advaite’s RapCov™ Rapid COVID-19 Test to BGI’s growing portfolio of diagnostic testing solutions. The Advaite test is a CLIA-waived, lateral flow immunoassay for the qualitative detection of immunoglobulin G (IgG) antibodies to the SARS-CoV-2 virus in human fingerstick whole blood samples. One of the first U.S.-manufactured point-of-care serology tests for which the Food and Drug Administration has granted for emergency use authorization, the RapCov™ Rapid COVID-19 Test is simple to use and delivers highly accurate results in 15 minutes by eliminating the requirement to send the sample to a laboratory. The partnership allows BGI to combine Advaite’s proprietary handheld test with its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2, providing hospital systems and other health care facilities with both central laboratory and point-of-care CLIA-waived testing solutions.

“Our rapid antibody test kits provide an ideal solution for screening mass populations and help patients determine whether they were once infected with the disease without knowing,” said Karthik Musunuri, CEO of Advaite. “Partnering with BGI to supply hospitals and other health care facilities with our innovative tests was a no-brainer in helping fight this ongoing pandemic.”

The COVID-19 pandemic has underscored the global need for manufacturing and distribution of accessible and accurate diagnostic testing devices, and BGI’s launch of dxpartnerships.com enables the company to partner with a broad range of organizations in the diagnostics testing space to advance diagnostic solutions. With proven commercial expertise and an established global footprint, partnering with BGI enables an organization to quickly and efficiently commercialize its in vitro diagnostic solutions.

“As one of the world’s largest suppliers of COVID-19 testing reagents and automation systems, we are thrilled to partner with Advaite to bring their groundbreaking testing solution to market and help stop the spread of the deadly coronavirus,” said Craig Hoechstetter, director of corporate development at BGI. “Not only does quick and easy testing alert individuals whether they are infected, it also enables them to get treated faster and take the necessary steps to minimize the spread of the virus to their colleagues, friends and families, ultimately saving lives. By offering end-to-end high-quality molecular and serology tests, we are providing a synergistic solution to tackling this pandemic head on by being one step ahead of the virus.”

To partner with BGI, visit dxpartnerships.com. For more information about BGI and the RapCov™ Rapid COVID-19 Test, visit bgi.com/us.

 

About BGI Americas Corporation

BGI Americas Corporation is the leading provider of genomics and proteomics services in the Americas Region as part of BGI Genomics, a public company listed on the Shenzhen Stock Exchange. Established in 2010, BGI Americas has grown to include presence in Boston and San Jose, serving a wide range of customers in genetics research, drug R&D and diagnostics. In response to the COVID-19 pandemic in 2020, BGI Americas introduced its diagnostic solutions to the north and south American markets, and initiated its in vitro diagnostics business. BGI brings 20 years of genomics experience to its customers and collaborators. We are committed to advancing genetic research, technologies and applications to benefit the mankind.

 

About Advaite

ADVAITE Inc. is a Malvern, Pennsylvania-headquartered biotech company focused on developing novel therapeutics and diagnostics to help patients suffering from a variety of debilitating diseases. The word “Advaite” means “one without a second,” unrivaled or unique. At ADVAITE, our team aspires to be just that.

Currently, ADVAITE Inc. is focused on developing novel point-of-care assays to help combat the modern world’s deadliest disease, COVID-19. With a high-complexity CLIA laboratory based in Chicago, Illinois, and an expanded state-of-the-art R&D facility in Malvern, Pennsylvania, ADVAITE is continuously innovating, developing and commercializing best-in-class point-of-care tests to address this pandemic and help impact large populations.

 

About RapCov™ Rapid COVID-19 Test

The ADVAITE RapCov™ Rapid COVID-19 Test is a lateral flow immunochromatographic assay for the qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick whole blood specimens. Testing of fingerstick whole blood specimens is limited to laboratories certified under CLIA, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the POC, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

 

  • This test has not been FDA cleared or approved, but the FDA has authorized it for emergency use by authorized laboratories;
  • This test has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • The emergency use of this 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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