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NovoPM 2.0

Novogene Precision Medicine 2.0 (NovoPM 2.0) is a comprehensive genomic profiling test for solid tumours that uses Next Generation Sequencing (NGS) technology to analyse 484 cancer-related genes for clinically significant alterations at the DNA level. The genes analysed are known to be relevant to the diagnosis and treatment of various solid tumours according to the National Comprehensive Cancer Network (NCCN) guidelines and medical literature. The test is performed in Novogene’s CAP-accredited laboratory and analysed by in-house bioinformatics specialists. The resulting report provides personalised treatment recommendations for patients based on their genomic profile.

Advantages of NovoPM 2.0 with Novogene
Quality Management

Systems that meet the requirements of national and international standards, including CAP, CLIA and ISO accreditation.

Flexible Sequencing Strategies

No limit on samples number

High Capacity

Industry-leading turnaround time

High Quality

Guaranteed Q30 ≥ 85%

Bioinformatics Expertise

Publication-ready results and bioinformatic consultants available for data interpretation

NovoPM 2.0 Highlights
  • Comprehensive genomic profiling of 484 cancer-related genes to match patients with the right treatment
  • CAP-compliant sequencing laboratory
  • High read depth increases the accuracy of analysis
  • Cost-effective solution for solid-tumour cancers

Gene Targets

NovoPM 2.0 interrogates the complete coding regions of 468 genes and the introns of 43 genes for all four types of genomic abnormalities: SNV, InDel, CNV and fusion. A comparison of the gene lists between NovoPM 2.0 and the FDA-approved FoundationOne CDx is shown in Figure 1. The mutation status of some of these genes can guide the potential application of multiple FDA-approved targeted and/or immunotherapies as shown in Table below. The other genes are also analyzed for their relevance to the diagnosis and/or treatment of various solid tumors according to the medical literature. The clinical interpretation of detected mutations in those genes is done according to Novogene’s comprehensive in-house oncology knowledgebase constructed based on public resources including GeneCards, CKB, OncoKB, ClinVar PMC, Drugs@FDA, Drug Information Portal (NIH), Selleck, PharmGKB, DGIdb, DRUGBANK, Drugs.com, ClinicalTrials.gov, ICTRP, ChiCTR, KEGG and Cell Signaling. In addition, our oncology knowledgebase incorporates ~1,000 germline BRCA1/2 variants previously reported to be unique in Chinese breast cancer and ovarian cancer patients1.

Figure 1. NovoPM 2.0 vs. FoundationOne CDx

Testing Workflow

Table 1. Gene targets in NovoPM 2.0 that are associated with FDA-approved or NCCN-recommended therapies

Indication Biomarkers FDA-approved or NCCN-recommended therapies
Non-Small Cell Lung Cancer
EGFR 19Del and L858R Gilotrif® (afatinib), Iressa® (gefitinib) or Tarceva® (erlotinib)
EGFR T90M Tegrisso® (osimertinib)
ALK rearrangements Alecensa® (alectinib), Xalkori® (crizotinib), Zykadia® (ceritinib), Alunbrig® (brigatinib) or Lorbrena® (Lorlatinib)
BRAF V600E Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib)
ROS1 fusion Xalkori® (crizotinib)
Melanoma BRAF V600E or V600k Tafinlar® (dabrafenib), Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib), Zelboraf® (vemurafenib) or Braftovi® (encorafenib) in combination with Mektovi® (binimetinib)
Breast Cancer
ERBB2 (HER2) amplification Herceptin® (trastuzumab), Perjeta® (pertuzumab), Tykerb® (lapatinib) or Nerlynx (neratinib)
gBRCA alterations and ERBB2 (HER2) negative Talzenna® (talazoparib) or Lynparza® (olaparib)
PIK3CA alterations Piqray® (Alpelisib)
Colorectal Cancer
RAS wild-type Erbitux® (cetuximab), Vectibix® (panitumumab) or Stivarga® (regorafenib)
Ovarian Cancer BRCA1 and BRCA2 alterations Lynparza® (olaparib) or Rubraca® (rucaparib)
Certain solid tumours
MSI Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
NTRK1/2/3 Vitrakvi® (larotrectinib)
TMB Keytruda® (pembrolizumab)

 

Sample Requirements

Sample type Amount Volume Concentration Description Collection tube recommended
Genomic DNA
≥ 1 µg No degradation or slight degradation
1.5 ml or 2 ml microcentrifuge tube
FFPE* genomic DNA ≥ 1 µg ≥ 20 µl ≥ 10 ng/µl Fragments should be longer than 1500 bp
ct/cfDNA ≥ 60 ng No genomic DNA contamination
Whole blood ≥ 2 ml 3-5ml recommended K2EDTA tube or ACD (yellow-top) tube.

Paediatric sample – EDTA (purple-top) tube

FFPE* tissue
≥ 10 sections of 5-10 µm thickness tissue area > 25 mm2 Operation tissue paraffin slides
Pathological tissue patch box / 2 ml microcentrifuge tube
≥ 20 patches
(> 3 mm2 per patch)≥ 30 patches
(> 2 mm2 per patch)
Biopsy tissue paraffin slides

*FFPE: Formalin-fixed, paraffin embedded.