The Solid Tumor Profile Test is a validated comprehensive genomic profiling assay that simultaneously sequences 184 cancer related genes. These genes have been known to carry variants which are drivers and/or are associated with cancer formation and development.
Using ultra-deep next generation sequencing (NGS) of DNA from formalin fixed paraffin embedded (FFPE) tumor biopsy sections, the test identifies base changes, insertions, deletions, and copy number variations which can be matched with targeted therapies and clinical trials.
The Solid Tumor Profile Test is offered to every patient with a solid tumor. The test provides clinically actionable information to guide treatment decisions based on the genomic profile of patient's specific tumor.
Since cancer is a disease attributed to alterations in the DNA, identifying these alterations may uncover treatment options that have not yet been considered.
Solid Profile test results provide information on targeted therapies, immunotherapy, and relevant clinical trials.
One biopsy required- we can perform the test on a minute amount of DNA, much less then required by other service providers. This means that in many cases we ensure that only one biopsy will be required from the patient.
Clinical relevance- 184 carefully selected cancer-associated genes undergo an evidence-based review process to maximize clinical utility in an informative easy to understand final report.
High accuracy- we isolate tumor cells from every biopsy enriching tumor DNA content achieving higher accuracy.
Stringent criteria- stringent assay conditions together with bioinformatics filters reduce sequencing artifacts generating the most accurate data set with an extremely small number of candidate causative variants for consideration.
Results comparison- for accurate identification of somatic mutations, we compare tumor DNA sequencing to patient's normal DNA (extracted from saliva) and to our proprietary genomic database.
Confirmed results- when possible, an additional sequencing technology, the golden standard Sanger sequencing is used to confirm the reported variants.
TMB & MSI- we provide the Tumor Mutation Burden (TMB) and Microsatellite Instability (MSI) to help guide immunotherapy treatment decisions.
Solid Profile Test workflow follows several steps which are concluded with the test report.
The test is based on a unique approach to obtain DNA from micro-dissected formalin fixed paraffin embedded (FFPE) sections taken from patients’ biopsy, so the majority of the sample DNA represents cancer cells. It interrogates the genomic changes that occur in cancer cells, which is typically compared the normal genome (taken from blood or saliva samples).
Extracted sampled DNA is processed and maintained (library preparation) for downstream next generation sequencing (NGS) which is further confirmed and assembled (through bioinformatics) for analysis by our medical experts which finally produce the results for the Test Report.
Our results are presented in an easy-to-understand report. The identified actionable genomic alterations are listed in a table that also provides information of targeted therapies and relevant clinical trials.
The beginning of the report will show a table which lists biological drugs which may suit the annotated mutation identified in the patient’s tumor. In addition, we will provide annotations for drug treatments which are approved or non-approved by the FDA for the patient’s specific cancer or to a different type of cancer.
The table will also include relevant clinical trials for the physician to consider referring the patient to enroll in. Ultimately, the results and drugs will be prioritized according to clinical relevance. Technical data regarding DNA sequence depth of the annotated mutation will be indicated in order to assure the accuracy of the technology.
In the core of the report, complete information regarding the genomic alteration will be described with its etiology along with data regarding the possible treatments and detailed references to sustain the results which appear in the report.
The report will be submitted to the authorized physician within 30 days from receiving the biopsy and blood (or saliva) samples in AID Genomics' genetic labs.
Positive result – variants were identified, which can be treated with approved FDA drugs for the patient’s specific cancer type.
Positive result –variants were identified, which can be treated with approved FDA drugs for a different cancer type.
Positive result – variants were identified which can be treated with drugs that are under clinical trials.
Negative result – mutations were identified; however, no known drugs are available to treat these mutations.
Negative result – there is a possibility that no mutations are identified. This result might occur due to the gap of knowledge that still exist in specific DNA sequences of certain genes or the actual involvement of changes within these genes which may lead to cancer.