OraSure Technologies has submitted two FDA 510(k) applications for a rapid molecular self-test for chlamydia and gonorrhea (CT/NG)

**OraSure Technologies has submitted two FDA 510(k) applications for a rapid molecular self-test for chlamydia and gonorrhea (CT/NG) and an at-home urine collection device (Colli-Pee), signaling a major push into decentralized STI diagnostics. The CT/NG test delivers results in 30 minutes using Sherlock Biosciences’ platform, while the Colli-Pee device supports private, self-collected sample workflows. OraSure estimates the CT/NG market exceeds $1.5 billion, with most testing still centralized — highlighting a ripe opportunity for point-of-care disruption.** --- ## 🔍 Strategic Summary for Diagnostics Stakeholders - **Test Format:** Disposable, self-collected swab-based molecular test for CT/NG - **Turnaround Time:** ~30 minutes, no electrical connection required - **Platform:** Sherlock Biosciences molecular engine - **Collection Device:** Colli-Pee urine collection system for multiple STI indications - **Market Opportunity:** >$1.5B TAM; majority of U.S. CT/NG tests still processed in central labs - **Regulatory Status:** FDA 510(k) submissions filed for both test and device - **Strategic Implication:** OraSure aims to decentralize STI testing, improve privacy, and expand access --- ## 📣 Why This Matters for GRN IVD Consulting Clients The OraSure submission underscores a broader trend: **molecular diagnostics are moving closer to the patient.** As decentralized platforms gain traction, stakeholders need clear, comparative insights into: - **Workflow integration** of rapid molecular platforms - **Regulatory pathways** for POC molecular assays - **Market sizing and segmentation** across infectious disease verticals - **Competitive positioning** of CT/NG platforms vs lab-based PCR That’s exactly what the **GRN IVD Consulting Point-of-Care Market Report** delivers — a strategic, investor-ready breakdown of: - **POC molecular trends** across respiratory, STI, and GI panels - **Platform comparisons** (Cepheid, Abbott ID NOW, Cue, OraSure, BD Veritor) - **SWOTs, battle cards, and algorithm overlays** for board-level decision-making - **Reimbursement, workflow, and adoption barriers** decoded Whether you're a diagnostics manufacturer, investor, or hospital lab leader, this report equips you to navigate the **next wave of decentralized infectious disease testing.** 📩 Register to access the full report and stay ahead of the curve.