SRY Test Consent Information

The SRY genetic test performed by Amplexa Genetics is a screening test designed solely to detect the presence of a specific DNA sequence within the SRY gene. The analysis is limited to this target and is not intended to evaluate any other genes, genetic variants, or medical conditions.

Scope of the Analysis

Amplexa Genetics performs the analysis using a single probe specific to the SRY gene. An internal housekeeping gene is used a positive control for monitoring proper sample collection and for the performance of the analysis reaction. This gene has no clinical relevance and is only used for monitoring amplification performance. No additional genetic testing or broader genomic analysis is performed on the submitted sample.

Storage of Samples and Data

After the analysis has been completed, biological samples are destroyed in accordance with our laboratory procedures. However, the test result and technical data are retained securely in our laboratory database for documentation, quality assurance, and regulatory purposes, in accordance with applicable data protection and laboratory requirements. Personal data will be erased after the applicable retention period.

Interpretation of Results

This test is intended as a screening assay and should not be considered a definitive diagnostic test.

• Negative screening result: No SRY sequence is detected using the assay performed.
• Positive screening result: Detection of the SRY sequence indicates that additional clinical evaluation and confirmatory testing are recommended. A positive screening result alone is not sufficient to establish a diagnosis or determine an individual's clinical condition.

Follow-up Recommendations

If the screening result is positive, we will pass on the result to the federation/association medical team to convey the result and guidance. We recommend referral to the appropriate healthcare professional for confirmatory testing, clinical assessment, and any further investigations considered necessary. Decisions regarding diagnosis and clinical management should be based on confirmatory laboratory findings together with the individual's clinical presentation.

Consent

By submitting a sample for analysis, you acknowledge that you have read and understood the information above and consent to:

• Analysis of your sample for the SRY gene only.
• Storage of the test result and associated analytical data in our secure laboratory database.
• Destruction of the biological sample after testing has been completed in accordance with our laboratory procedures.
• Receipt of the screening result with the understanding that any positive finding should be confirmed through appropriate follow-up testing.