FDA approves first home test for gonorrhea, chlamydia

The Food and Drug Administration has approved the first home diagnostic tests for chlamydia and gonorrhea in response to the escalating STD epidemic in the United States.

LetsGetChecked, a New York-based laboratory testing company, will make the Simple 2 Test available, aiming to provide a convenient and private solution for people concerned about their sexual health.

Rather than requiring individuals to visit a healthcare facility, this innovative test kit begins with a comprehensive health questionnaire completed by the patient, which is then reviewed by a qualified physician.

The Simple 2 Test is then mailed directly to the patient for home use, with the collected samples mailed back to a certified laboratory for analysis.

LetsGetChecked specializes in enabling people to take samples in the comfort of their own homes, send them to a lab and securely provide results online. Priced at $99, the Simple 2 Test does not require a prescription, eliminating the need to visit the doctor’s office for invasive testing.

Federal regulators see this development as a critical public health victory, offering a means to address the persistently rising rates of STDs in the US, a trend exacerbated during the pandemic by limited access to routine preventive care.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized the importance of this authorization in promoting consumer access to diagnostic tests, aligning with the broader goal of bringing more health care services into the home.

Following in the footsteps of HIV home testing, the Simple 2 Test represents the first FDA-approved self-test for chlamydia and gonorrhea. Patients receive the discreetly packaged test at their doorstep, complete a health questionnaire for examination by a doctor and submit vaginal swabs or urine samples.

Collected samples are mailed to accredited laboratories, ensuring the accuracy of results, and people receive results within two to five days via a secure online portal.

While the home test presents the risk of false negatives, the FDA warns that it could lead to delays in effective treatment and increased community spread. However, LetsGetChecked offers counseling services and, if necessary, helps administer the required medications.

In addition to benefiting those who test positive, LetsGetChecked extends its services to partners, providing treatment options at an additional cost. This approach aims to address the interconnected nature of sexual health and minimize the spread of STIs within communities.

The increase in STI cases, totaling 2.53 million in 2021, highlights the urgent need for accessible and discreet testing options. LetsGetChecked’s Simple 2 Test addresses the challenges posed by the pandemic, promoting sexual health awareness and empowering people to seek early treatment.

The increase in cases is attributed to factors such as low access to preventive care, reduced disease control during the pandemic, and evolving attitudes toward contraception, highlighting the need for preventive measures to limit the spread of STIs.