MicroSigX IBD Enterosight Diagnosis Aid Tender in USA - 143073314

Procurement Summary

Country: USA

Summary: MicroSigX IBD Enterosight Diagnosis Aid Pre-Clinical Biomarker Qualification & Reagent Development Study - Phase 1 (U.S.)

Deadline: 31 Jul 2026

Posting Date: 11 Jun 2026

Other Information

Notice Type: Tender

TOT Ref.No.: 143073314

Document Ref. No.: MSX2026_US_IBD_PC01

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Private

Tender Value: Refer Document

CPV Classification

48814400 - Clinical information system

Purchaser's Detail

Purchaser: MicroSigX Biotech Diagnostic Limited
Attn: Yolly Chan
16/F, 208 Johnston Road, Wanchai, Hong Kong
Tel: +85228360982 | Email: [email protected]
USA

Tender Details

MicroSigX IBD Enterosight Diagnosis Aid Pre-Clinical Biomarker Qualification & Reagent Development Study - Phase 1

Objective of This Tender:To select a qualified U.S.-based Contract Research Organization (CRO) to execute a prospective, observational, IRB-approved, IDE-exempt (21 CFR 812.2(c)(3)) Pre-clinical biomarker qualification study for the IBD Enterosight Diagnosis Aid – a non-invasive, stool-based, microbiome-derived in vitro diagnostic (IVD) intended to aid in the diagnosis of inflammatory bowel disease (IBD: Crohn’s disease and ulcerative colitis) and differentiate IBD from irritable bowel syndrome (IBS). This study will generate analytical and clinical validation data to support a future FDA De Novo classification submission.

Key Study Requirements:

• Enroll 400 adult subjects (≥18 years) across four cohorts:

• 100 Ulcerative Colitis (UC) – confirmed by endoscopy + histopathology

• 100 Crohn’s Disease (CD) – confirmed by endoscopy + histopathology

• 100 Symptomatic Non-IBD Controls (IBS)-diagnosed per Rome IV criteria, with organic disease ruled out

• 100 Healthy Controls – no GI symptoms or chronic illness

• Collect two 3g stool samples per subject using sponsor-provided preservative tubes, stored and shipped at ambient temperature (15–25°C) with real-time monitoring

• Consolidate samples at a U.S. central lab and ship to MicroSigXs laboratory in Hong Kong.

Documents

 Tender Notice