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Henry Schein Announces the Availability of a Coronavirus 2019 (COVID-19) Point-of-Care Antibody Rapid Test

Posted on Thursday, March 26, 2020

Henry Schein, Inc. (Nasdaq: HSIC) announced today the availability of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test, intended to be administered at the point of care. The test delivers results within 15 minutes from a pinprick with no instrumentation required.

Health care professionals can use the results of the test, along with a patient’s medical history, symptoms, and results of other relevant testing, to make informed decisions about patient treatment and care.

Henry Schein is working through multiple channels to distribute the tests in the United States as quickly as possible in response to the urgent need for rapid, accurate testing. The Company anticipates having at least several hundred thousand tests available by March 30 and significantly increased availability beginning in April 2020.

The Standard Q COVID-19 test is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG antibodies associated with the 2019 novel coronavirus (SARS-CoV-2) in blood drawn with a pinprick.

Because serology tests measure antibodies, they can help assess the likelihood of past as well as present infection, and are meant to be used as an aid to health care professionals in diagnosing the mid- to later stages of the viral infection. Along with other information, such as the presence of symptoms, the tests may help health care professionals assess whether individuals (including health care workers) have recovered from the virus. Follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.

The Standard Q COVID-19 IgM/IgG Rapid Test is being made available under emergency guidance issued by the U.S. Food and Drug Administration (FDA).

“Henry Schein is committed to providing health care professionals with quality products they can rely on to care for patients,” said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. “Henry Schein has played a key role in providing point-of-care testing to health care professionals, and is now responding to the urgent need for wide availability of rapid point-of-care testing for COVID-19. This pandemic is an unprecedented situation, and making rapid diagnostic tools available to health care professionals is critical for detecting and mitigating the spread of the coronavirus.”

As the world’s largest distributor of health care solutions to office-based dental and medical professionals, Henry Schein is uniquely positioned to distribute the Standard Q COVID-19 test efficiently. Henry Schein plans to make the Standard Q COVID-19 test available for use by physician offices, hospitals, and other relevant health care institutions.

The distribution of the kit is part of Henry Schein’s continued efforts to address pandemic preparedness and response. Among other efforts, Henry Schein is in direct contact with the World Health Organization and other multilateral and domestic organizations as part of Henry Schein’s role as the private-sector lead of the Pandemic Supply Chain Network, a public-private partnership created in 2015 to improve the efficiency of the supply chain for personal protective equipment.

The Standard Q COVID-19 test is manufactured by SD Biosensor, Inc., a global bio-diagnostic company. SD BioSensor is represented by VelocityDX in the United States. Henry Schein intends to add other tests from VelocityDX and other suppliers specific to COVID-19, with the goal of offering a wide array of point-of-care tests for health care professionals.

A Q&A addressing the new test and providing additional information about it is available at www.henryschein.com/COVID19Statements.

For customers interested in more information about the Standard Q COVID-19 IgM/IgG Rapid Test, please contact Henry Schein at (844) 211-0140.

To learn more about what Henry Schein is doing to address this unprecedented situation and the actions the Company is taking to get more product into the hands of those who need it most – health care workers – please visit www.henryschein.com/COVID19update.

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 19,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that improve operational success and clinical outcomes. Our Business, Clinical, Technology, and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories, government and institutional healthcare clinics, as well as other alternate care sites.

Henry Schein operates through a centralized and automated distribution network, with a selection of more than 120,000 branded products and Henry Schein private-brand products in stock, as well as more than 180,000 additional products available as special-order items.

A FORTUNE 500 Company and a member of the S&P 500® index, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 31 countries. The Company's sales from continuing operations reached $10.0 billion in 2019, and have grown at a compound annual rate of approximately 13 percent since Henry Schein became a public company in 1995.

For more information, visit Henry Schein at www.henryschein.comFacebook.com/HenrySchein, and @HenrySchein on Twitter.

Cautionary Note Regarding Forward-Looking Statements

In accordance with the "Safe Harbor" provisions of the Private Securities Litigation Reform Act of 1995, we provide the following cautionary remarks regarding important factors that, among others, could cause future results to differ materially from the forward-looking statements, expectations and assumptions expressed or implied herein. All forward-looking statements made by us are subject to risks and uncertainties and are not guarantees of future performance. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance and achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These statements are identified by the use of such terms as "may," "could," "expect," "intend," "believe," "plan," "estimate," "forecast," "project," "anticipate," “to be,” “to make,” “understand or understanding,” or other comparable terms. Forward looking statements include the number of tests intended to be made available and the timing for availability, the nature of the target market, as well as the efficacy or relative efficacy of the test results given that the test efficacy has not been independently verified under normal FDA procedures. A full discussion of our operations and financial condition, status of litigation matters, including factors that may affect our business and future prospects, is contained in documents we have filed with the United States Securities and Exchange Commission, or SEC, and will be contained in all subsequent periodic filings we make with the SEC. These documents identify in detail important risk factors that could cause our actual performance to differ materially from current expectations.

Risk factors and uncertainties that could cause actual results to differ materially from current and historical results include, but are not limited to: effects of a highly competitive and consolidating market; increased competition by third party online commerce sites; our dependence on third parties for the manufacture and supply of our products; our dependence upon sales personnel, customers, suppliers and manufacturers; our dependence on our senior management; fluctuations in quarterly earnings; risks from expansion of customer purchasing power and multi-tiered costing structures; increases in shipping costs for our products or other service issues with our third-party shippers; general global macro-economic conditions; risks associated with currency fluctuations; risks associated with political and economic uncertainty; disruptions in financial markets; volatility of the market price of our common stock; changes in the health care industry; implementation of health care laws; failure to comply with regulatory requirements and data privacy laws; risks associated with our global operations; risks associated with the Novel Coronavirus Disease 2019 (COVID-19); risk associated with the United Kingdom's withdrawal from the European Union; transitional challenges associated with acquisitions, dispositions and joint ventures, including the failure to achieve anticipated synergies/benefits; financial and tax risks associated with acquisitions, dispositions and joint ventures; litigation risks; new or unanticipated litigation developments and the status of litigation matters; the dependence on our continued product development, technical support and successful marketing in the technology segment; our dependence on third parties for certain technologically advanced components; risks from disruption to our information systems; cyberattacks or other privacy or data security breaches; certain provisions in our governing documents that may discourage third-party acquisitions of us; and changes in tax legislation. The order in which these factors appear should not be construed to indicate their relative importance or priority.

We caution that these factors may not be exhaustive and that many of these factors are beyond our ability to control or predict. Accordingly, any forward-looking statements contained herein should not be relied upon as a prediction of actual results. We undertake no duty and have no obligation to update forward-looking statements.







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