Home 5 Clinical Diagnostic Insider 5 Recent FDA Approvals Show Growing Sophistication of At-Home Tests

Recent FDA Approvals Show Growing Sophistication of At-Home Tests

by | Jan 30, 2024 | Clinical Diagnostic Insider, FDA-dtet

Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.

The U.S. Food and Drug Administration (FDA) has granted its first ever De Novo approval for an at-home test for gonorrhea and chlamydia. Experts say the approval signals that such assays, which have always been fairly simple, are likely to become more complex in the coming years.

The FDA granted the approval last November for the Simple 2 Test, manufactured and distributed by LetsGetChecked.1 The test may be ordered online. Consumers can provide a urine or vaginal swab sample at home via the Hologic® Aptima® collection devices, then mail it to LetsGetChecked’s lab for testing. Results may be accessed by the consumer via a smartphone app. LetsGetChecked charges $99 for the test, or $69.30 every three months for regular testing.2

The approval is “a noteworthy public health turning point,” says Jill Helmke, DPh, NPh, clinical trials director and chief product officer for NuView Life Sciences, a Utah-based firm that develops diagnostics and therapies for breast cancer and glioblastoma. “This test specifically empowers the patient to be proactive in the privacy of their home, which expands healthcare opportunities.”

Sexually transmitted infections (STIs) have also become an issue of concern for public health experts. According to the Centers for Disease Control and Prevention, STI diagnoses have been trending upward over the past decade, with cases of syphilis and gonorrhea rising 74 percent and 28 percent, respectively, between 2017 and 2021.3

The New York City-based LetsGetChecked was founded little more than a decade ago and has raised nearly $400 million in a half-dozen funding rounds, including two contributions by Illumina Ventures, the California-based investment venture focused on bringing new testing to market.4 In addition to the at-home testing for gonorrhea and chlamydia, it also has tests for HIV, syphilis, and diabetes, among others.

The importance of at-home testing to labs

At-home testing has always been a nearly under-the-radar business for the laboratory sector, with most tests focused on issues such as pregnancy as opposed to disease diagnosis. But these tests have become more sophisticated in recent years, testing for disease precursors for ailments such as colorectal cancer. And during the COVID-19 pandemic, hundreds of millions of at-home tests for the virus were distributed by the US government.

“The advent of COVID-19 at-home testing has definitely accelerated consumers’ willingness to take an at-home test,” says Stuart Altman, director of product management for Simple HealthKit, a Fremont, California-based manufacturer and distributor of at-home tests, in an email. “One of the biggest effects here is simply awareness and familiarity with taking a test at home, which certainly wasn’t as common for most people who were not already routinely testing for some other health-related reason.”

Altman notes that COVID-19 tests provide rapid results, which he observes “may be limited in terms of being able to immediately connect patients to care and by the level of test result information.”

Helmke adds that along with tests for STIs, the at-home market now also has assays that track hormone levels (which is another product of LetsGetChecked and its competitors). “These tests are ‘hot’ because there is something actionable that can come from the results—a visit to the doctor, a telehealth phone call with a physician or nurse practitioner, or medication therapy management by a licensed pharmacist,” she says.

Altman observes that at-home tests are also becoming more complex and are likely to continue in that direction. “Clinical-grade laboratory testing solutions are finally in the homes of consumers, and they have the power to provide insight across an incredibly wide field of biomarkers,” he says. One example he highlights is the Q-pad, distributed by San Francisco-based Qvin. The device collects a user’s menstrual blood to test for A1C levels, bypassing a venous blood draw. It received FDA clearance in early January.5

The FDA appears cognizant of the growth of at-home testing. The agency recently announced it was seeking public comment on at-home testing. “Access to devices outside a clinical care setting may help bridge the gap by bringing health care directly to patients, wherever they are—at home, at work, in cities, in rural communities,” the FDA stated.6

Moreover, Simple HealthKit is also one of those ventures that in recent months took a step toward making the public more aware of at-home testing. Last June, the company inked a deal with Walmart to make its tests for diabetes, influenza, and STIs available through the retail giant’s website.7


    1. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection

    1. https://www.letsgetchecked.com/simple-std-test/

    1. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/std/std-us-2021.html

    1. https://www.crunchbase.com/organization/letsgetchecked/company_financials

    1. https://www.prnewswire.com/news-releases/qvin-introduces-q-pad-transforming-womens-health-with-fda-cleared-lab-testing-using-menstrual-blood-302027835.html

    1. https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/cdrh-seeks-public-comment-increasing-patient-access-home-use-medical-technologies

  1. https://www.globenewswire.com/en/news-release/2023/06/12/2686370/0/en/Simple-HealthKit-Launches-At-Home-Testing-Kits-on-Walmart-com.html


Other recent FDA approvals for at-home tests and testing products include the following:

Company NameApproval DateWhat Was Approved
Boston Easy BiotechJanuary 19, 2024Approvals for 14 variations of Boston Easy’s multi-drug rapid drug test cup
Chemtron Biotech, Inc.January 12, 2024A total of 38 approvals for drug cup and dip card tests for substances such as morphine, fentanyl, and tricyclic antidepressants
Jant Pharmacal Corp.January 9, 2024Approval for a saliva test for cotinine
BTNX, Inc.January 9, 2024Approval for a rapid saliva-based test for cotinine
2San LLCJanuary 8, 2024Approval for a leukocyte esterase test for urinary tract infections
Checkable Medical Inc.January 8, 2024Approval for a vaginal pH screening kit
Guangzhou Decheng Biotech Co.December 22, 2023A total of 16 approvals for urine test cups for various drugs
Preferred Med SupplyDecember 18, 2023A total of 15 approvals for multi-panel drug test cups
PregmateDecember 14, 2023An approval for a leutenizing hormone ovulation test
DiaCarta, Inc.December 1, 2023An approval for a fecal occult blood test
Greater Goods, LLCNovember 3, 2023An approval for a blood glucose monitoring system
Source: FDA 510(k)/De Novo clearance database for over-the-counter tests and test products.

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