Tech #1346: Clinician-reported Genetic testing Utility InDEx (C-GUIDE™)
The Clinician-reported Genetic testing Utility InDEx (C-GUIDE™) is a validated instrument designed to assess the clinical value of genetic testing from the provider perspective. It evaluates utility across key domains—including diagnosis, medical management, risk awareness, and patient and family well-being—supporting evidence generation for clinical and policy decision-making.
Technology Reference Number
#1346
Inventors
IP&C Contact
Therapeutic Area
Genetic Testing
Category
Health Outcome Measure
Keywords
C-GUIDE™, genetic testing, clinical utility, clinician-reported outcomes, diagnostic impact, medical management, precision medicine, health policy, decision-making
Invention Description
Decision makers require evidence of clinical utility to inform policy and funding decisions related to genetic testing. To address this, our inventors have developed and validated a novel outcome measure to assess the clinical utility of genetic testing from providers’ perspectives.
The Clinician-reported Genetic testing Utility InDEx (C-GUIDE™) is designed to capture the clinical utility of a genetic test as it relates to:
- Understanding diagnosis and prognosis
- Informing medical management
- Awareness and actionability of reproductive and health risks for patients and family members
- Patient and family well-being
C-GUIDE™ is completed by clinicians that order, disclose, or manage genetic test results. It is available on paper or electronically and takes about 5 minutes to complete per patient
Advantages
C-GUIDE is divided into three sections:
- Primary Findings: Genetic test results related to the primary indication for testing (includes 17 items).
- Secondary Findings: Genetic test results unrelated to the primary indication for testing but are still clinically relevant (includes 9 items).
- Pharmacogenomic Findings: Genetic test results related to genes that affect drug response (includes 4 items).
Additional Information
Available in various languages.
- A version for use in prenatal care (C-GUIDE™ Prenatal) has been also validated and we are in the process of validating versions for critical care and newborn screening.
- We have also validated a patient-reported outcome measure called The Patient-reported Genetic testing Utility InDEx (P-GUIDE™) which is available for licensing.
