Any decision regarding treatment plan development or change should not be solely based on these test results. It is highly recommended that these findings are correlated with the patient’s clinical, biochemical, pathological, radiological findings and family history for decisions on diagnosis, prognosis, or treatment.
The therapy information provided in this report is based on FDA approved drugs data, NCCN guidelines, peer-reviewed published literature, standard clinical databases, and the strength of biomarker results. This information must only be used as a guide. These therapies may or may not be suitable/beneficial to a particular patient. This clinical report summarizes potentially effective medications, potentially ineffective medications, and medications that may pose a higher risk of adverse reactions by mapping the patient’s genetic alterations to the biomedical reference information. The report may also provide prognostic and diagnostic biomarkers detected or shown for the given disease context. The final decision on any treatment, diagnostic or prognostic change must be made with all the relevant patient information at hand.
The clinical trials information provided in this report is compiled from www.clinicaltrials.gov using currently available data, however completeness of information provided herein cannot be guaranteed. This information should only be used as a guide and specific eligibility criteria should be reviewed thoroughly for the concerned patient. Agiomix is nor responsible for any change in information on a specific trial nor does it guarantee or promise an enrolment in any clinical trials.
The identification of a genomic biomarker does not automatically imply pharmacological effectiveness or ineffectiveness. The medications identified by the treating physician may or may not be suitable for use on a particular patient. Thus, this clinical report does not guarantee that any specific agent will be effective in the treatment of any specific condition. Also, the absence of a treatment option does not determine the effectiveness or predict an ineffective or safety-relevant effect of a medication selected by the treating physician. The final treatment decision always lies with the physician.
The classification and clinically relevant information for the reported variants is based on peer-reviewed publications, public clinical databases, medical guidelines (NCCN, ASCO, AMP) or other publicly available information and it has been ensured that the information provided is up to date at the time of report generated, however continuous updates may happen in public domains. Also, the classification of variants can change based on the updated literature evidence. Re-analysis of the results can be requested at additional cost.
This clinical test is performed on the patient’s tumor sample without a paired blood sample; therefore, it may include variations which may be of germline origin. However, this test is designed and validated for the detection and reporting of somatic genomic variants only and does not discriminate between germline and somatic variants. If clinically warranted, appropriate germline testing and genetic counselling for the patient should be considered for further evaluation.
Assay- Qualitative detection of 94 mutations across BRAF, EGFR, ERBB2, KRAS, and PIK3CA genes.
Method used – MassArray
Sample type: FFPE tissue (tumor cell content >20 %)
Samples required in a batch – 10 samples + 1 Negative control + 1 positive control
List of detectable mutations:
|Gene||Coverage*||No of Variants*|
|BRAF||Codons 469 (exon 11), 594, 600 (exon 15)||4|
|EGFR||Exon 19 indels, exon 20 insertions, and substitutions across exons 18, 19, 20 and 21||46|
|ERBB2||Exon 20 insertions||2|
|KRAS||Codons 12, 13 (exon 2) and 61 (exon 3)||14|
|PIK3CA||Codons 542, 545 (exon 9) and 1047 (exon 20)||4|
Limitations: the assays have a limit of detection of 2.5% or lower variant allele frequency with an average specificity across all assays of 99.8%.
|Sensitivity (Allelic Frequency)||Specificity (Average Across all Assays)|
|HS Lung||9% at 0.63%
45% at 1.25%
78% at 2.5%
97% at 5%
3% at 10%
|Assay||Limit of Detection (%)||Specificity|
This assay can detect only mutations in BRAF, EGFR, ERBB2, KRAS, and PIK3CA genes as mentioned above.
The accuracy of this assay depends on quality of sample, tumor content and allele frequency (1 to 10 %).