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KDx Diagnostics

KDx Diagnostics

San Francisco, United States· Est.
kdxdiagnostics.com
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Private Company

Total funding raised: $17M

Overview

KDx Diagnostics is a private, commercial-stage diagnostics company specializing in bladder cancer detection with its URO17® test. The test, based on the novel Keratin 17 (K17) biomarker, has demonstrated high sensitivity and specificity in clinical studies and has received FDA Breakthrough Device Designation. The company is currently conducting a clinical trial for FDA approval while generating early revenue through LDT and international kit sales.

OncologyUrology

Technology Platform

Proprietary immunocytochemical assay platform based on the Keratin 17 (K17) biomarker for detecting urothelial carcinoma cells in urine samples. Compatible with standard laboratory autostainers.

Funding History

2
Total raised:$17M
Series A$15M
Grant$2M

Opportunities

The high recurrence rate of bladder cancer creates a large, sustained market for non-invasive monitoring tests.
FDA approval via the Breakthrough Device pathway could enable rapid US market penetration and favorable reimbursement.
The Keratin 17 platform may have utility in diagnosing other keratin-expressing cancers, allowing for pipeline expansion.

Risk Factors

The company is heavily dependent on the success of its single product, URO17, and its ongoing FDA clinical trial.
It faces competition from established and emerging non-invasive bladder cancer tests.
As a private company, it carries execution and financing risks associated with scaling operations and completing regulatory milestones.

Competitive Landscape

KDx competes in the non-invasive bladder cancer diagnostic market against established urine-based tests (e.g., NMP22, UroVysion, Cxbladder) and newer molecular assays. Its claimed advantage is a combination of very high sensitivity and specificity. It also competes indirectly with cystoscopy, the invasive standard of care. Gaining urologist adoption against these incumbents is a key commercial challenge.

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