Emerging Omicron Variant Reinforces the Role of Rapid Antigen Testing
Ellume, a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers, has conducted an assessment of the new Variant of Concern, Omicron, using the available genome sequencing data, and is highly confident that the Ellume COVID-19 Home Test will detect this new variant.
"By design, Ellume's core technology in our COVID-19 antigen test detects an area of the virus that remains highly conserved among COVID-19 variants and is unaffected by the mutations in the Omicron variant," said CEO of Ellume Dr. Sean Parsons. "We are continuously monitoring COVID-19 mutations to ensure the clinical performance of our test is unaffected by any changes to the virus's genome."
In response to the growing concern over the new Omicron variant, the Biden administration has announced plans to reimburse at-home COVID-19 tests for 150 million insured Americans. This and other actions announced this week, support the administration's broader strategy to mitigate the spread of COVID-19 this winter by expanding access to at-home testing nationwide.
Parsons continued, "We support the Biden administration's announcement to encourage more widespread rapid testing. Accessibility to rapid diagnostics play an important role in managing outbreaks, reducing community transmission and pressure on healthcare systems. Ellume remains steadfast in its commitment to deliver home tests to communities across the United States in the most impactful way."
Our participation in the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative, provides an opportunity for the Ellume COVID-19 Home Test to be verified against any new Variants of Concern. The RADx Variant Task Force assesses the impact of emerging SARS-CoV-2 variants on diagnostic molecular and antigen tests. Ellume's involvement in this program provides reassurance that the Ellume COVID-19 Home Test continues to detect circulating Variants of Concern, including the Delta and Omicron variants, without any reduction in clinical performance of the test.
The arrival of the Omicron variant highlights the ongoing need for widely available rapid testing, and Ellume stands ready to meet the demand in product with the establishment of a U.S. based manufacturing facility in Frederick, Maryland. Ellume's Frederick facility is scheduled to commence production by the end of 2021, and once fully operational will have the capacity to produce about 15 million COVID-19 Home Tests per month.Ellume's tests can now be found online and in select nationwide pharmacy chains, with additional retailers to be announced in December.
In the face of new variants, Ellume's automatic result reporting feature is critically important in helping monitor disease outbreaks. In all cases, the test result is reported in real-time to federal and state public health authorities, alleviating the responsibility of the consumer.
THE ELLUME COVID-19 HOME TEST:
In developing the Ellume COVID-19 Home Test (ECHT), Ellume took a different approach than many other antigen products on the market – one that provides increased sensitivity without the cost, complexity and accessibility issues of a laboratory-based molecular (PCR) test. The ECHT is the only rapid home antigen test that uses fluorescent technology, which provides superior sensitivity and has previously been used exclusively by healthcare professionals. The ECHT was the first rapid home antigen test to receive an EUA and is one of the few home tests clinically proven for symptomatic and asymptomatic use without requiring serial testing. The test's swab enables deeper sample collection, offering the best compromise between sample quality and patient comfort. The test's app guides the user through the test steps and displays the results in words within 15 minutes ensuring easy result interpretation. The test also includes a sample integrity control system to identify if insufficient sample was collected which minimizes the risk of false negative results. The ECHT was awarded a TIME Best Inventions of 2021 award and a Popular Science Best of What's New for 2021 award.
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. It is at the forefront of accurate, rapid and accessible testing that is integral to today's COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume's key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume has a global COVID-19 and TB partnership with QIAGEN, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.
Further information can be found at ellumehealth.com.
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