A New Era of Testing Emerges as Leading Supplier of COVID Tests Receives FDA Emergency Use Authorization for Combo COVID + Flu Test

SUNNYVALE, Calif., May 8, 2024 /PRNewswire/ -- iHealth Labs, Inc. (iHealth), a leading provider of digital health solutions, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company's 3-in-1 COVID-19/Flu A&B Rapid Test Kit for self-testing at home, with results in 15 minutes. As one of the first over-the-counter rapid antigen tests for COVID-19 and influenza (commonly known as the flu) A & B in the US, the 3-in-1 test offers a convenient and fast at-home testing experience.

The 3-in-1 test is suitable for individuals aged 2 and above. Assistance from an adult is required for children aged 2-13. The 3-in-1 test inherits the same user-friendly steps of iHealth's stand-alone at-home COVID test. The difference lies in squeezing 5 drops onto a test card, compared to the previous 3 drops. Results for COVID-19, Influenza A or Influenza B are displayed in 15 minutes.

With the launch of the 3-in-1 COVID-19/Flu A&B Rapid Test, iHealth, one of the leading suppliers of at-home COVID tests to the federal government, ushers in a new era of at-home testing post-pandemic that will enable consumers to stop guessing what illness they may have when symptoms emerge. According to infectious disease physicians, it's important to know if you have COVID or the flu as they have different treatments--although they have similar symptoms.

During the height of the pandemic, iHealth delivered over 1 billion at-home COVID tests in the now well-recognized orange box packaging, throughout the country. The company recently won a tech innovation company of the year award from the city of Sunnyvale where it is headquartered, for its immense capacity to rapidly scale up to produce and distribute COVID tests to as many people as soon as possible.

Physicians also emphasize the heightened vulnerability of children to common viruses, especially during the school season, making this continually a focus of concern for parents. According to the National Library of Medicine, children are particularly susceptible to influenza infections and serve as the primary contributors to the transmission of the virus.

"In the face of uncertainty surrounding symptoms such as fever, sneezing, cough, or fatigue and what illness they may be indicative of, our at-home 3-in-1 self-test offers peace of mind for parents who might be worried that their vulnerable young children have COVID-19 or the flu," noted Jack Feng, CEO of iHealth. "They don't need to prolong the worrying and waiting for answers—experience the assurance of instant results within 15 minutes. This allows for appropriate medical care tailored to the particular virus, easing concerns for you and your family."

Continued Feng, "Parents with multiple kids, with testing of a child who has symptoms of illness, can also protect their other kids from catching the illness with the early detection. And imagine the time that is saved if several of your kids or other family members might have the flu or COVID and the hassle you are alleviating by testing them all at home instead of the entire family having to head to the doctor's office."

The FDA, in recent statements, has expressed its advocacy and support for test innovation and working with test developers to advance availability and greater access to at-home infectious disease testing to best support public health needs. The 3-in-1 self-test from iHealth aligns seamlessly with this vision, empowering individuals to take prompt actions based on quick results, ultimately contributing to their safety and well-being.

"The release of the 3-in-1 test demonstrates iHealth's ongoing dedication to provide convenient, accessible, and affordable testing to consumers and enable them to proactively manage their own health from the comfort of their home or wherever they are," stated Feng. "As we did with the stand-alone at-home COVID test during the pandemic, our goal now with this second generation of at-home testing that introduces combination tests such as the 3-in-1, is to evolve with consumer and public healthcare needs to deliver products that address immediate concerns."

For more information on the iHealth COVID-19/Flu A&B 3-in-1 Antigen Rapid Test, visit the product page on the website.

About the iHealth COVID-19/Flu A&B Rapid Test

The iHealth COVID-19/Flu A&B Rapid Test is intended for over-the-counter (OTC) use and the qualitative detection of SARS-CoV-2, Influenza A and/or Influenza B nucleocapsid protein antigen in anterior nasal (nares) swab samples. This test does not determine if you had COVID-19/Flu A&B in the past or if you have immunity.

The iHealth COVID-19/Flu A&B Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

The iHealth COVID-19/Flu A&B Rapid Test is only for use under the Food and Drug Administration's Emergency Use Authorization.

About iHealth Labs, Inc.

iHealth, a leading provider of digital health solutions, offers a range of IoT medical devices: blood pressure monitors, glucometers, thermometers, oximeters, and at-home test kits (including its widely-recognized orange-box COVID-19 tests). Since its founding in 2010, the company's consumer-friendly healthcare solutions have been making quality health management more accessible and affordable.

SOURCE iHealth Labs, Inc.