Quidel’s QuickVue® At-Home OTC COVID-19 Test Now Available for Sale Through Amazon
Quidel Corporation (QDEL) announces the availability of its QuickVue® At-Home OTC COVID-19 Test for online purchase on Amazon. This test allows consumers to self-administer a COVID-19 test and receive results in just 10 minutes. The product shows high accuracy, with positive agreement with PCR tests at 83.5% and negative agreement at 99.2%. A 2-pack is priced at $24.95 with free shipping. The test is available under FDA's Emergency Use Authorization but is not FDA approved.
- High accuracy with positive results agreeing with PCR 83.5% of the time.
- Negative results agreement is 99.2%, indicating reliability.
- Convenient online purchasing through Amazon enhances accessibility.
- The QuickVue test is only authorized for emergency use and not FDA approved.
- Dependence on a limited number of distributors raises potential supply risks.
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that its non-prescription QuickVue® At-Home OTC COVID-19 Test is now available in the United States to consumers for online order through e-commerce retailer Amazon.
“The ability to quickly order and receive the QuickVue® At-Home tests and screen for COVID-19 in the privacy of their homes will give greater peace of mind to countless American families seeking a return to normal,” said Douglas Bryant, president and CEO of Quidel Corporation.
The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get results in 10 minutes from nasal swab samples. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR
A 2-pack COVID test is currently available for sale on amazon.com for
The QuickVue® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home OTC COVID-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Visit http://www.quickvueathome.com for more information.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
View our story told by our people at www.quidel.com/ourstory.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation: the impact and duration of the COVID-19 global pandemic; competition from other providers of diagnostic products; our ability to accurately forecast demand for our products and products in development, including in new market segments; our ability to develop new technologies, products and markets and to commercialize new products; our reliance on sales of our COVID-19 and influenza diagnostic tests; our reliance on a limited number of key distributors; quantity of our product in our distributors’ inventory or distribution channels; changes in the buying patterns of our distributors; the financial soundness of our customers and suppliers; lower than anticipated market penetration of our products; third-party reimbursement policies and potential cost constraints; our ability to meet demand for our products; interruptions, delays or shortages in the supply of raw materials, components and other products and services; failures in our information technology and storage systems; our exposure to data corruption, cyber-based attacks, security breaches and privacy violations; international risks, including but not limited to, economic, political and regulatory risks; continuing worldwide political and social uncertainty; our development, acquisition and protection of proprietary technology rights; intellectual property risks, including but not limited to, infringement litigation; the loss of Emergency Use Authorizations for our COVID-19 products and failures or delays in receipt of reviews or regulatory approvals, clearances or authorizations for new products or related to currently-marketed products by the U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities or loss of any previously received regulatory approvals, clearances or authorizations or other adverse actions by regulatory authorities; our contracts with government entities involve future funding, compliance and possible sanctions risks; product defects; changes in government policies and regulations and compliance risks related thereto; our ability to manage our growth strategy and successfully identify, acquire and integrate potential acquisition targets or technologies and our ability to obtain financing; our acquisition of Alere’s Triage® business presents certain risks to our business and operations; the level of our deferred payment obligations; our exposure to claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us, including the ongoing litigation between us and Beckman Coulter, Inc.; we may need to raise additional funds to finance our future capital or operating needs; our debt, deferred and contingent payment obligations; competition for and loss of management and key personnel; business risks not covered by insurance; changes in tax rates and exposure to additional tax liabilities or assessments; and provisions in our charter documents and Delaware law that might delay or impede stockholder actions with respect to business combinations or similar transactions. Forward-looking statements typically are identified by the use of terms such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with the Securities and Exchange Commission from time to time, should be carefully considered, including those discussed in Item 1A, “Risk Factors” and elsewhere in our Annual Report on Form 10 K for the year ended December 31, 2020 and in our subsequent Quarterly Reports on Form 10 Q. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this press release. Except as required by law, we undertake no obligation to publicly release any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210514005487/en/
FAQ
When is the QuickVue® At-Home OTC COVID-19 Test available for purchase?
What is the price of the QuickVue® At-Home OTC COVID-19 Test?
What are the accuracy rates of the QuickVue COVID-19 Test?
What is the status of FDA approval for the QuickVue test?
Where can I find more information about the QuickVue® At-Home OTC COVID-19 Test?
