NEW YORK – Following de novo clearance this month of its combination influenza and COVID-19 lateral flow test for over-the-counter use, Houston-based Healgen Scientific expects to scale up manufacturing in both the US and China to meet global demands during the current respiratory virus season.
Healgen's Rapid Check COVID-19/Flu A&B Antigen Test detects influenza A, influenza B, and COVID-19 from anterior nasal swabs in approximately 15 minutes. Authorized for self-testing by people ages 14 years and older, the test can also be used on children as young as 2 years old.
In announcing that the test received de novo clearance, the US Food and Drug Administration noted that Healgen's test was evaluated by the Independent Test Assessment Program (ITAP) of the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech division. In the evaluation, the test correctly identified 99 percent of negative and 92 percent of positive SARS-CoV-2 samples, 99.9 percent of negative flu A and flu B samples, and 92.5 percent and 90.5 percent of positive flu A and flu B samples, respectively, according to the FDA.
Because of "the specificity and sensitivity that we were able to achieve, it is only recommended that an individual do a single test," with Healgen's assay, Albert Berger, the company's VP of marketing, said in an interview, adding that this is a key differentiator of Healgen's OTC offering compared to most COVID antigen tests in the growing at-home testing space which require two serially administered tests taken a day or two apart for conclusive results. The high accuracy of Healgen's test is due to proprietary chemistry and manufacturing techniques, he noted.
As a de novo-cleared test, Healgen's combo assay will now serve as the predicate device for future 510(k) submissions from competing offerings. For more than a year, the FDA has been winding down the Emergency Use Authorization of COVID-19 tests, though that process has yet to completely wrap up, as the agency intends for all COVID tests to complete a full regulatory review process.
Competing offerings for future 510(k) flu/COVID combo tests could include any of 20 multi-analyte lateral flow tests for home use that have been granted EUA since 2021, or approximately 10 rapid combo tests that have been evaluated by RADx's ITAP.
The ITAP evaluation was coordinated by VentureWell under a contract awarded by the National Institute of Biomedical Imaging and Bioengineering. Tests are submitted by manufacturers responding to a solicitation whose primary place of business is in the US and who have technologies that can quickly scale production.
While Healgen's test isn't first to market — EUA OTC tests are still on the shelves — it does have the advantage of being fully cleared and rigorously evaluated by a reputable source. It may also have advantages in terms of manufacturing volumes and in having a US manufacturing facility.
Founded in Houston by Bingliang Fang and his brother Bryan in 2007, Healgen is a wholly owned subsidiary of Anju, China-based Zhejiang Orient Gene Biotech, a publicly traded company that develops, manufactures, and sells in vitro diagnostic products. According to the firm, its main products are point-of-care diagnostic reagents, mainly for drug screening.
Healgen obtained EUA for a COVID test in June 2020, which was initially distributed by Confirm BioSciences and Menarini Silicon Biosystems. Healgen also worked with Siemens Healthcare Diagnostics to develop a rapid antigen self-test under the Clinitest brand.
Healgen has distributed more than 400 million of its Rapid COVID-19 Antigen Self-Test Kits in the US to date, Berger said, and more than 2 billion test kits in 80 countries globally.
Still, "the lion's share of our revenues come out of China," Berger said, adding, "we have excellent relationships in the country, being based there, that allow us to get the raw materials that we need and want."
In May, Healgen obtained 510(k) for a COVID-19 test, followed by EUA for the combo test with a serial testing indication in June. When the firm cut the ribbon on a combined headquarters and manufacturing facility in Houston in August, it was already aiming to manufacture the OTC combo flu/COVID tests there.
"Some of the larger US tenders that we're pursuing require a 'Made in the USA' product in order to qualify," Berger explained, adding that some US customers are also willing to absorb a price differential for such a seal.
Healgen can also pivot test manufacturing to other lines of its parent company; Orient Gene has 325 global automated production lines with a daily production capacity of more than 22 million tests. During the pandemic, it also moved 15 production lines to the US and invested more than $100 million in large-scale manufacturing and warehouse facilities in New York, New Jersey, and Texas.
The Houston facility is expected to provide approximately 200 new jobs over the next three years, Healgen said in August, and it can produce roughly 500,000 tests per day. It is also slated to produce RSV tests in the near future, the firm added recently, and Berger suggested that RSV is a logical step for a future wave of OTC tests.
Meanwhile, Healgen has a menu of tests for infectious disease diagnosis — including a strep A test that was cleared in 2022 — as well as extant relationships with major US retailers that sell its drug testing kits, Berger said.
"We have hundreds of other tests currently in development," both in Houston and in China, he noted, adding that Healgen and Orient Gene can quickly adapt these to meet changing global needs.
The cost of the OTC combo test will be determined by retailers — Berger said Healgen does not provide a manufacturer's suggested retail price to its partners but rather lets them set their own price — and the company is now working diligently to secure combo test contracts with major retailers and with the US government. Healgen is also gauging demand and planning its manufacturing scale-up using end user algorithms and logistics.
"We don't see any difficulties being able to keep up with demand," Berger said, given dual manufacturing in the US and China.