ADVAITE’s High Complexity CLIA Lab Receives Authorization from Yale University to Offer Highly Accurate COVID-19 SalivaDirect™ Test
CHICAGO, ILLINOIS, USA, November 11, 2020
ADVAITE Inc., a biotech at the forefront of the COVID-19 pandemic response, announces that the company’s high complexity CLIA laboratory operating out of Chicago, IL has been authorized to offer Yale University’s SalivaDirect™ test. SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories, such as ADVAITE’s Chicago Laboratory, which have been formally designated as authorized laboratories by YSPH under the EUA 202097.
SalivaDirect™ provides analytical sensitivity of 99%, and specificity of 94%, establishing it as one of the gold standards for COVID-19 testing. The method has several unique differences compared to traditional PCR (polymerase chain reaction) methods, including (i) the use of saliva instead of the more invasive nasopharyngeal swab, and (ii) the lack of an additional nucleic acid extraction step, which can save valuable time when processing samples.
In a spring 2020 pilot program led by the Yale School of Public Health, the National Basketball Association (NBA), and the National Basketball Players Association (NBPA), SalivaDirect™ was successfully used to test asymptomatic people within the NBA and NBPA communities throughout the completion of the basketball season.
“The SalivaDirect COVID-19 PCR-based nucleic acid test will allow us to shift away from a defensive symptom-based strategy to a proactive surveillance-based strategy that enables communities and businesses to stay open safely during the pandemic”, said Sandeep Jain M.D., Chief Scientific Officer & Co-Founder, ADVAITE Inc. “As an example of success of this strategy, mandatory saliva testing programs are currently being used in public universities to allow safe student and staff participation in campus housing, performing arts and athletics”.
The addition of SalivaDirect™ to ADVAITE’s existing testing and R&D capabilities uniquely positions the company at the forefront of combatting the ever-growing COVID-19 pandemic.
Other FDA EUA tests offered by the ADVAITE high complexity CLIA laboratory include:
- xMAP® SARS-CoV-2 Multi-Antigen IgG Assay, which detects the presence or absence of antibodies in serum against three different SARS-CoV-2 antigens. By using multiple antigens, this assay may provide earlier, more sensitive results; and
- NxTAG® CoV Extended Panel Assay which is a qualitative test for the detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens.
ADVAITE’s continued enhancement of its accurate and reliable testing capabilities is critical to the nation-wide effort to contain the spread of this deadly virus as the CDC confirms over 10 million cases of COVID-19 in the U.S. so far.
ADVAITE Inc. is a Malvern, PA 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, we aspire to be just that. Currently, ADVAITE Inc. is focused on developing novel point-of-care assays and deploy them to help combat the modern world’s deadliest disease, COVID-19. With a new high complexity CLIA laboratory based in Chicago, Illinois, and an expanded state-of the-art R&D facility in Malvern, PA; ADVAITE is continuously innovating, developing and commercializing point-of-care tests to address this pandemic and help impact large populations. ADVAITE currently markets RapCov™ COVID-19 Rapid Test (http://www.rapcov.com) a lateral flow immunochromatographic assay intended for the presumptive qualitative detection of IgG antibodies to the SARS-CoV-2 in fingerstick whole blood from individuals who are suspected of COVID-19 virus exposure. ADVAITE is also housed within the University of Illinois Incubator Laboratory facility which serves as a home to both life science and engineering firms at various stages of development within a vibrant entrepreneurial ecosystem that leverages University assets and connects Innovation, Infrastructure, Networks, Talent and Capital within and beyond the university.
Important Information About SalivaDirect™:
SalivaDirect™ has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized 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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Director of Commercial Operations, ADVAITE Inc.