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Limitations and Warnings


The etiology of many diseases is multifactorial, that is, disease can occur as a result of various factors, including both inherited and acquired genetic variants, diet, lifestyle choices and age. The interpretations given by Opus 23 Pro evaluates inherited genetic variants in data uploaded to our server, and interpretations are only as accurate as the data received from the genomic test: It is possible that inaccuracies in the genomic test results could lead to false interpretations. It is also possible that variants in genes and genetic regions not tested in the DNA sequencing test may contribute to an individual’s risk for disease. Therefore a negative result in a gene where no pathogenic variants are detected does not eliminate the individual’s disease risk. Further, a positive test result does not guarantee an occurrence of disease since the variants in most genes are not 100% penetrant. Rather, pathogenic variants may predispose a person to a higher or lower risk of disease. The results of the test must be interpreted in the context of the individual’s clinical background. Genetic counseling is recommended for the individual and for other at-risk family members.

Opus 23 Pro strives to provide the most accurate possible data interpretation. As part of this mission we constantly monitor and refine our data analysis algorithms. If and when an improvement is identified, the new algorithm becomes available immediately on creation. In that event, a corrected report will be available by re-indexing the patient’s dataset and re-running the report. Such re-analysis of patient data may lead to reclassification of patient results. Opus 23 Pro and Datapunk LLC takes no responsibility for any harm arising from incorrect data being uploaded to our server or incorrect data interpretation, errors or omissions by the software or by the curating staff.

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