Oncologica is the first laboratory in Europe to offer the Oncofocus assay for personalised oncology

The Oncofocus precision oncology test was developed as part of the US NCI-MATCH (Molecular Analysis for Therapy Choice) clinical trial programme, the largest precision oncology trial in history. The MATCH programme coordinated by the NIH/NCI/FDA involves 2,400 NCI trials centres in the USA with assays standardised at reference centres at the Frederick National Laboratory, Massachusettes General Hospital – Harvard, MD Anderson and Yale. These trials involve sponsorship/partnership between the NCI and the leading 20 BioPharma companies. Tumour biopsy profiling has been performed on over 900,000 samples collected from 2,400 NCI-affiliated hospitals, coordinated by 14,000 investigators and including data from 120 phase 3 and 215 early phase trials. It is the most comprehensive precision oncology test that directly links a tumour’s genetic profile to molecularly targeted therapies. The Oncofocus Test, a targeted sequencing platform, is designed to detect actionable mutations in cancer genes targeted by on-market oncology drugs or treatments in clinical trials. Intelligent design is driven by Oncologica’s bioinformatics platform linked to the world’s largest curated compendium of cancer genomic information, which includes content aligned to approved therapies and indications.

Our targeted next generation sequencing (NGS) assay enables simultaneous detection of thousands of genetic variants across the major driver genes relevant to solid tumours. Targeted actionable hotspots include SNVs, indels, CNVs and gene fusions. Notably these driver cancer genes have been selected because they are the most clinically relevant and have been approved for reimbursement in the US. Analysis of the output from the Oncofocus Test is performed using Oncofocus Reporter, an analytical system used to identify and prioritize potential treatment strategies. This informatics pipeline represents a curated set of published evidence from clinical trials that supports the matching of driver genetic variants with clinical therapeutic options. Oncologica carries out DNA sequencing of patient tumour samples using semiconductor chip technology directly translating chemically encoded information (A,C,G,T) into digital information. Semiconductor sequencing has major advantage over other sequencing technologies because it can be used to sequence low DNA input FFPE biopsy samples with high throughput and at reduced cost.   ngs-scheme2Comprehensive analysis of major cancer driver genes in one single workflow dramatically reduces the cost of molecular profiling and accelerates reporting times. The Oncofocus Test generates a comprehensive picture of actionable mutations providing the clinician with a detailed molecular blue print for optimal therapy choices and improved patient outcomes and prevents the unwarrented prescribing of expensive targeted therapies to patients unlikely to benefit from such treatments. Detected variants are linked to clinical therapeutic options including:

  • FDA approved therapies
  • guideline referenced therapies
    1. NCCN, EMA and ESMO guidelines in the patients’ cancer type
    2. variants referenced in NCCN, EMA and ESMO guidelines in another cancer type
  • therapies entered into worldwide phase I, II, III and IV clinical trials (variants referenced as inclusion criteria in clinical trials)

 

Targeted NGS for all Solid Tumour Types

LUNG CANCER

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Targeted NGS for all Solid Tumour Types

MELANOMA

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Targeted NGS for all Solid Tumour Types

PROSTATE TUMOUR

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LONGITUDINAL DYNAMIC MONITORING

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ONCOFOCUS SERVICE FLOW

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