What is Comprehensive Tumor Gene Panel?
Comprehensive Tumor Gene Panel is an all-inclusive Next-Generation Sequencing (NGS) test that targets DNA and RNA variants (gene re-arrangements / gene fusions) from the same Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample (in case of solid tumors) and blood or bone marrow aspirate sample (in case of leukemias or blood cancers).
- According to Globocan data from 2018, around 2.25 million people were affected by cancer
- This number is known to grow by 1.15 million every year
- Males are at 9.81% risk to develop cancer before the age of 75 and females at 9.42%
- The most common types of cancer in males include lip, oral cavity, lung, stomach, colorectal, and esophagus, while in females it includes breast, lip, oral cavity, cervix, lung, and gastric cancers (in descending order).
Gastrointestinal Stromal Tumor
Why do you need the test?
- Offers an accurate and cost-effective method to identify mutations, fusions, and amplifications across 170 genes associated with response or resistance to specific targeted therapies in several cancer types
- Enables determination of the most appropriate targeted therapy for each patient with any cancer type based on the genomic profile
- Helps in the assessment of prognosis and guiding treatment for patients baseline (at the time of diagnosis) as well as at disease progression/recurrence
Who needs to get tested?
Treating oncologists can also decide ideal candidates, who can benefit from this test by means of targeted treatment and refer them testing.
- Strict quality control measures at different stages of sample processing, data acquisition and analysis adhering to international clinical laboratory practice guidelines such as CAP, thus ensuring highly precise and accurate results
- High throughput NGS data analysis, curation, and interpretation of the mutations and fusions are performed by well-trained clinical scientists/genome analysts and cancer genome experts
- The report provides –
→ Clinically significant alterations and its interpretations
→ Their associations with drug efficacy
→ Recommended targeted therapies/possible mechanisms of resistance
→ Prognosis and available active clinical trials
- Supporting medical evidence from large clinical studies that guide oncologists in making treatment decisions during the complete course of cancer management that includes diagnosis, targeted therapy, surveillance and relapse
- Clinical reporting and interpretations are based on international guidelines such as ASCO, AMP, CAP, NCCN, and ESMO
- The test is validated in-house and the mean sequencing depth of the panel is >/= 250x on 100+ clinical samples, reference standards, and cell lines
- The sensitivity, specificity, and accuracy to detect SNVs, Short InDels, and fusions as mentioned below
* Any gene fusion detected with a confidence of more than 10 spanning read support will be considered a true mutant
** Gene amplifications from NGS is based on prediction algorithms using bioinformatics approach. Any gene predicted to have a copy number >= 6 copies is considered as a true prediction for a probable gene amplification that needs to be confirmed using alternate testing platforms viz MLPA, FISH and other technologies. In-house clinical validation limits to CNV prediction for ERBB2 and MET Oncogene.