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
www.ihealthlabs.com 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.
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SOURCE iHealth Labs, Inc.