FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
For the first time, the FDA has issued marketing clearance for a lab test detecting gonorrhea and chlamydia that relies on samples users collect at home. Previously, HIV was the only sexually transmitted infection (STI) for which the agency had cleared at-home sample collection. The De Novo authorization opens up a new, wider market for STI direct-to-consumer (DTC) tests and kits. And with nationwide STI cases continuing to climb to levels not seen in decades, the new in vitro diagnostic (IVD) authorization comes at an opportune moment.
FDA greenlights at-home collection kits for chlamydia and gonorrhea
There were more than 2.5 million reported STI cases in the US in 2021, according to the US Centers for Disease Control and Prevention (CDC).1 Chlamydia and gonorrhea accounted for over 2.3 million of them, with each disease creeping up 4 percent compared to the previous year. Gonorrhea rates have increased 118 percent since 2009. Chlamydia is the most prevalent STI in the US with over 1.6 million cases reported in 2021.2
On November 15, the FDA announced that the Simple 2 Test from LetsGetChecked had become the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization. The test is available online without a prescription for $99 USD. It comes with equipment and instructions enabling users to collect a urine sample or vaginal swab that’s sent to a lab for testing. Users also complete a questionnaire providing information about their health for use by a clinician. Test results are delivered online, and a clinician then follows up with the user to discuss further testing and treatment options if the test comes back positive or invalid.3
Significance of the new clearance
The LetsGetChecked authorization is likely to have a significant and positive impact on the STI lab testing market, particularly the larger market segment that focuses on screening, as opposed to tests for patients with symptoms, says Donna Hochberg, partner with Massachusetts-based consulting firm Health Advances.
All of the STI screening tests on the market are technically LDTs. Until now, no at-home sample collection device had secured IVD clearance. The new clearance future-proofs these tests if new FDA regulations take effect and all LDTs will have to be approved by the agency, explains Hochberg, who is leader of Health Advances’ Diagnostics and Life Sciences Tools practice. The approval also bolsters test makers’ attempts to persuade consumers to buy, and payers to reimburse, their products.
While at-home testing and sample collection generally makes testing more convenient, there are also significant privacy ramifications in the realm of STIs. Until now, individuals who suspected they might have chlamydia or gonorrhea had to go to their doctor’s office to get tested. At-home sample collection allows for testing without a physician visit. This could significantly increase utilization and treatment.
In clearing the LetsGetChecked test, the FDA also created a pathway that other companies can follow to secure De Novo and 510(k) marketing clearance for their own at-home sample collection STI products. The FDA announcement notes that the agency is establishing a template defining the labeling and performance controls which, in combination with general controls, “provide a reasonable assurance of safety and effectiveness for tests of this type.”3 Companies will then be able to use the 510(k) pathway to bring at-home-sample-collection-based STI tests to market by demonstrating their substantial equivalence to a predicate device.
Test makers will also get a boost from the recent surge in consumer awareness of home testing products since the COVID-19 pandemic. “Consumers discovered via COVID rapid antigen testing that they could collect their own samples, run their own tests, and get results in minutes without having to leave their homes,” Hochberg explains.
However, Hochberg also cautions STI screening test makers not to celebrate just yet, citing major barriers, especially payer reluctance to cover the tests. “Most of the current STI screening testing is self-pay.” In that sense, she compares the emerging self-collection and self-test STI market to that for consumer genetic test products.
Here are the key new FDA clearances that were announced in the period from early October through mid-November 2023:
New FDA Approvals and Emergency Use Authorizations (EUAs)
|510(k) clearance for Simple 2 Test, first diagnostic test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization
|510(k) clearance for DNA/RNA Shield™ SafeCollect™ Saliva Collection Kit for COVID-19 molecular testing
|Clearance for PD-L1 IHC 22C3 pharmDx as companion diagnostic assay to identify gastric or gastroesophageal junction adenocarcinoma patients for combination treatment with Merck’s KEYTRUDA® (pembrolizumab) checkpoint inhibitor
|510(k) clearance for Flowflex® COVID-19 Antigen Home Test, which originally received EUA clearance in 2021
|Breakthrough Device designation for Elecsys® Neurofilament Light Chain test for multiple sclerosis
|Clearance for cobas® HPV real-time PCR test for use on cobas® 5800 instrument
|Foundation Medicine (Roche subsidiary)
|Clearance for FoundationOne®CDx and FoundationOne®Liquid CDx as companion diagnostics for Pfizer’s BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation
|Foundation Medicine (Roche subsidiary)
|Clearance for FoundationOne®CDx as companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib) for treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or are following prior systemic treatment or who have no satisfactory alternative treatment options
|Clearance for Alinity m high risk HPV assay
|Clearance for Abbott RealTime IDH1 Assay as companion diagnostic for Servier Pharmaceuticals’ Tibsovo (ivosidenib) in patients with relapsed or refractory myelodysplastic syndrome
|Inova Diagnostics (subsidiary of Werfen)
|510(k) clearance for Aptiva® Connective Tissue Disease (CTD) Essential reagent
|De Novo clearance for Dream Sock® over-the-counter, medical grade pulse oximeter for infants
|Breakthrough Device Designation for NeuroAccess™ device for transiently opening blood-brain barrier (BBB) to elevate concentration of cell-free DNA (cfDNA) analytes in blood circulation
|Breakthrough device designation for Paige Lymph Node artificial intelligence software for detecting breast cancer metastases in lymph node tissue
|Aria Diagnostics + SigTuple Technologies
|510(k) clearance for SigTuple AI100 with ShonitTM instrument to automate digitization of peripheral blood smear samples
|EUA for MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR test
|Breakthrough Device Designation for rapid bleeding test for determining clotting status at point of care
New CE Marks and Global Certifications
Notable European CE certifications announced during the period:
New Approvals in Europe
|Elecsys® Anti-HEV IgG immunoassay to detect IgG antibodies to hepatitis E virus in human serum and plasma
|Elecsys® Anti-HEV IgM immunoassay to detect IgM antibodies to hepatitis E virus in human serum and plasma
|Surelite 8 automated chemiluminescence immunoassay system
|Surelite 16 automated chemiluminescence immunoassay system
|RNXtract® kit using magnetic beads for RNA extraction from formalin-fixed paraffin-embedded tissue
|Clean Cell Free DNA Kit using magnetic beads to extract cfDNA from 1 mL of human plasma
|AAV5 DetectCDx™ electrochemiluminescence antibody assay as companion diagnostic to identify patients for treatment with BioMarin Pharmaceutical’s ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for severe hemophilia A
|Yourgene® DPYD genotyping assay to identify cancer patients with dihydropyrimidine dehydrogenase deficiency
|AliveDx (formerly Quotient)
|MosaiQ® Centromere Protein B microarray immunoassay to detect autoantibodies to centromere protein B for diagnosing connective tissue diseases
|AliveDx (formerly Quotient)
|MosaiQ® AiPlex CTD (connective tissue diseases) assay to detect autoantibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, centromere protein B, and ribosomal P for diagnosing CTDs
|AliveDx (formerly Quotient)
|Multiconstituent MosaiQ® AiPlex CTD Quality Controls
|VIDAS® TBI (GFAP, UCH-L1) blood test to assess mild traumatic brain injury based on combination of two brain biomarkers: GFAP and UCH-L1
|PCR-based class B infectious disease assays, including gastrointestinal tests and a test for the bacteria Bordetella
|Shanghai Kehua Bio-Engineering
|Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2
|LiDCO® board-in-cable module to connect to multi-patient monitoring platforms for advanced hemodynamic monitoring
Other international clearances announced during the period:
|Burning Rock Biotech
|OverC™ Multi-Cancer Detection Blood Test
|Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (reversible terminator sequencing method) to measure efficacy of immune checkpoint inhibitor therapy
|Droplex POLE Mutation Test targeting endometrial cancer mutations
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