CRISPR-TB Blood Test™

Developed and performed by: Ruthenium Diagnostics, LLC (CLIA #45D2310559)

in collaboration with Intelligenome, Inc. (IGDX, Inc)

Test Category: Proprietary Laboratory Analysis (PLA)

CPT/PLA Code: [pending AMA assignment]

• Specimen Type: Plasma or serum

• Analytical Method: Polymerase chain reaction (PCR) amplification of M.tb DNA followed by CRISPR-  

   based probe detection

• Detection: Fluorescence signal measured via quantitative PCR instrumentation

• Result Type: Qualitative – Detected / Not Detected

A qualified laboratory professional interprets and reports results to the ordering provider.

The CRISPR-TB Blood Test™, utilizing CRISPR technology and performed on qPCR, is a qualitative in vitro diagnostic test for the detection of Mycobacterium tuberculosis (M.tb) complex cell-free DNA in blood samples collected in EDTA plasma tubes from patients with clinical suspicion of tuberculosis or who have received antituberculosis therapy for less than three (3) days. This test is intended to aid in the diagnosis of tuberculosis when used in conjunction with clinical findings.

This test utilizes a proprietary CRISPR-based probe system designed to achieve high sensitivity for TB cfDNA in blood. Analytical and clinical performance characteristics have been determined by Ruthenium Diagnostics in compliance with CLIA regulations.

A 38-year-old male presents with cough, hemoptysis, night sweats, and weight loss after emigrating from a tuberculosis-endemic region. Chest imaging demonstrates cavitary lung lesions. The CRISPR-TB Blood Test™ is ordered for plasma DNA analysis.

Ruthenium Diagnostics, LLC

9440 Bellaire Blvd. Suite 110B

Houston, TX 77036

CLIA ID 45D2310559

This test was developed and is performed by Ruthenium Diagnostics, LLC. The test has not been cleared or approved by the U.S. Food and Drug Administration. The assay is validated and performed under CLIA regulations for high-complexity testing.