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IHealth Expands Into IVD Space With FDA EUA, Government Contract for Antigen Self-Test


NEW YORK ─ IHealth Labs' investment in the development of a rapid COVID-19 antigen test was based on its belief that it could leverage lateral flow technology as an affordable and rapid alternative to RT-PCR.

That confidence has paid off with tests that have been authorized for use during the pandemic, as well as a sizable contract with the US government.

The Sunnyvale, California-based firm, which once focused solely on medical device production and marketing, now has US Food and Drug Administration Emergency Use Authorizations for two tests. Also, it recently nabbed a $1.275 billion contract to supply one of them — a self-test that can be used at home — as part of the Biden Administration's efforts to get more rapid tests to the public.

With the onset of the COVID-19 pandemic, iHealth initially launched a no-touch thermometer, adding to a line of internet-connected medical devices it had begun producing in 2014. However, it quickly began the development of the antigen test "based on the belief that diagnostic tests would become an important factor in preventing viral transmission," Jack Feng, chief operating officer of iHealth, said in an interview.

On Jan. 13, the Department of Defense, in coordination with the US Department of Health and Human Services, awarded contracts to iHealth Labs, Abbott Diagnostics, and Roche Diagnostics, purchasing a combined total of 380 million over-the-counter COVID-19 antigen test kits. The DoD award of funds through the American Rescue Plan Act is part of the Biden Administration's plan to deliver 1 billion free at-home COVID-19 tests throughout the US in response to the Omicron variant. Americans can now order up to four free rapid antigen tests per residential address from On deadline, iHealth did not respond to a request for comment about the contract.

For iHealth, the DoD award was followed last Friday by an FDA EUA for its COVID-19 Antigen Rapid Test Pro, which qualitatively detects SARS-CoV-2 nucleocapsid antigens from anterior nasal swab samples and is intended for use at the point of care or in CLIA-certified laboratories.

The company, a subsidiary of China-based medical device manufacturing company Andon Health, had also obtained an FDA EUA in November for its COVID-19 Antigen Rapid Test, a lateral flow assay for use at home without a prescription to detect the SARS-CoV-2 nucleocapsid protein.

Established in the US in 2010, iHealth released its first product, a mobile-app enabled blood pressure monitor, in 2011. The following year, it launched a wireless blood pressure monitor and in 2013 a wireless blood glucose monitor.

"The idea to launch smart devices came from the belief that chronic medical conditions are a huge challenge for many countries, including the United States," Feng said.

The firm subsequently launched Unified Care, a platform for chronic disease management that incorporates monitoring and treatment for diabetes, hypertension, and other medical conditions using HIPAA-compliant cloud storage of patient information.

The EUA for the self-test set the stage for iHealth's entry into the in vitro diagnostics market and represented its expansion from the medical devices space, Feng noted. However, though iHealth is looking into expanding its product offering in diagnostics, it hasn't yet mapped out a roadmap for the types of products it wants to develop or a timeline for development.

Prior to the FDA EUA, the clinical performance of the self-test was evaluated at five US sites and involved the testing of 139 individuals with signs and symptoms of COVID-19 within the first seven days of symptom onset, according to a document filed with the FDA. Compared to highly sensitive molecular SARS-CoV-2 assays authorized by the FDA, the iHealth self-test identified 94.3 percent of positive samples and 98.1 percent of the negative samples.

For sales of the self-test, iHealth has largely relied on its distributors to market the product while it also initially offered the test at a lower price than its competitors, Feng said.

IHealth's tests are manufactured in China by Andon Health, which helps it reduce manufacturing costs and quickly ramp up capacity as needed, Feng said. On the other hand, for distribution in the US, the company has to ship all of its antigen tests by air to its warehouses in Sunnyvale, and Los Angeles, which adds to its costs.

Nonetheless, by the end of December, the firm was shipping 8 million tests per day to governments, public health organizations, distributors, and customers ordering at its website, and multiple planes are transporting tests to the US daily, Feng said.

Leo Friedman, founder and CEO of iPromo, a distributor of antigen tests, noted that while iHealth initially released its self-test at $13.99 for a package of two to gain market traction, last week it increased its price to $19.80 for two tests.

iPromo has been selling an average of 100,000 antigen tests per day produced by numerous IVD makers including iHealth, Friedman said, adding many factors point to continued rising demand for antigen tests but demand can fluctuate.

Possibly working in iHealth's favor is the fact that in the US, the number of over-the-counter tests that have been authorized by the FDA remains relatively modest. As of Jan. 18, the FDA had authorized 13 antigen over-the-counter, at-home tests and three over-the-counter molecular at-home tests.