NEW YORK--(BUSINESS WIRE)--LetsGetChecked, a global healthcare solutions company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its Simple 2 at-home collection system. FDA’s De Novo authorization makes LetsGetChecked’s testing system for chlamydia and gonorrhea the first-ever FDA-authorized home sample collection system with retail and online access to the collection kit. This FDA action creates a new regulatory classification, setting a new standard for at-home self-collection of samples for sexually transmitted infection (STI) testing in high complexity laboratories. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.
The Centers for Disease Control and Prevention (CDC) considers STIs – including chlamydia and gonorrhea – to be an epidemic. The CDC reports that in 2021 there were an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea. With the steady rise in STIs nationwide, LetsGetChecked recognizes the urgent need for accessible and accurate testing options. The authorization of its end-to-end testing system includes manufacturing, logistics, lab analysis, and healthcare support, which asserts LetsGetChecked's position as the gold standard of at-home care.
“We are honored to receive this landmark De Novo classification and authorization from FDA for our chlamydia and gonorrhea testing system, which demonstrates the value of our robust end-to-end at-home care system,” said Peter Foley, Founder and CEO of LetsGetChecked. “Our vertically integrated platform, coupled with the authorization of our testing solution will empower individuals to proactively manage their health from home. We greatly appreciate FDA’s collaboration throughout this process.”
LetsGetChecked’s Simple 2, which tests for gonorrhea and chlamydia through vaginal swab or urine sample for individuals 18 and older, includes an at-home sample collection kit that can be delivered directly to the user’s door with a prepaid shipping label to return the sample. Samples are collected using the Hologic®, Inc. Aptima® collection devices (Aptima® Urine Specimen Collection Kit or Aptima® Multitest Swab Specimen Collection Kit). All samples are analyzed in LetsGetChecked’s high-complexity laboratory, which is CLIA-certified and CAP-certified in the U.S. for testing with the Hologic Aptima Combo 2® assay (for CT/NG). Results are delivered online in approximately 2-5 days with follow-up virtual consultations and treatment available if needed.
“We are proud to support LetsGetChecked on this first-ever FDA-authorized at-home collection kit for chlamydia and gonorrhea, which uses our best-in-class technology,” said Hologic Diagnostics Solutions President Jennifer Schneiders, Ph.D. “Our priority as an organization is to ensure people have access to the highest standards of care to safeguard their health. As STIs continue to rise at alarming rates, we are committed to innovative testing strategies that bring additional testing options to people everywhere.”
This news comes as LetsGetChecked continues to deliver on its mission to empower people to live longer, happier lives by providing the tools to manage health from their home through health testing, genetic sequencing and insights, virtual care, and medication delivery for a wide range of health and wellness conditions. The company has served over ten million individuals and more than 1,000 corporate customers with health testing and virtual care services since it was founded in 2015.
To learn more about LetsGetChecked, please visit www.LetsGetChecked.com.
About LetsGetChecked
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from their home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015, the company empowers people with accessible health information and care to live longer, happier lives.
LetsGetChecked is available nationwide in the United States, the United Kingdom, and most EU countries. It is co-headquartered in Dublin and New York.
