Hedera Profiling 2 ctDNA Test Panel (HP2), 32-Gene NGS Liquid Biopsy Kit, 18 Tests

Hedera Profiling 2 (HP2) is a targeted 32-gene, hybrid-capture NGS liquid biopsy assay for profiling the most common solid tumors, including lung, breast and colorectal cancers. It detects SNVs, Indels, CNVs, Fusions and MSI from as little as 10 ng of plasma cfDNA and includes more than 80% of the ESCAT Level I genes. 18 tests per kit.

Kits are commercialized together with the Hedera Prime software and can be purchased separately.

Key Features

• Compact but comprehensive: 32 gene-panel for the detection of SNVs, Indels, CNVs, Fusions and MSI across > 10 most common tumor types in a single, DNA-only liquid biopsy assay
• Highly actionable: >80% of the ESCAT Level I genes are included in the panel including ESR1, METex14 and MSI status
• Fast and accurate: Swiftly integrates into your routine NGS workflow to get accurate results with low input material within 5 calendar days, with as little as 10ng of cell-free DNA (30ng input recommended)
• Robust software analysis: Backed by Hedera Prime software, save time on each report while ensuring accurate and reliable results
• Unique fusions detection method on DNA: Cutting-edge proprietary technology to detect fusions in ctDNA with unmatched precision, enhancing the accuracy of complex variants detection in plasma samples

Workflow

The kit integrates into your existing NGS workflow and sequencing instrument; tertiary analysis and reporting run in the Hedera Prime software.

• 3 hours - hands on time
• 5 calendar days - from sample to report
• < 5 minutes - tertiary analysis & reporting

Specifications

Performance

32-gene NGS panel optimized to run samples across all solid tumor types recommended by ESMO for ctDNA testing including the vast majority of ESCAT Level I biomarkers published to date

Hedera Profiling 2 ctDNA test panel includes SNVs, Indels, CNVs, Fusions, and MSI

The panel detects a broad range of cfDNA variants as well as Microsatellite Instability (MSI).

Results from a unique international (8 countries), multicenter (11 centers), analytical validation study

Results based on 30 ng of input cfDNA (commercial reference control DNA) for all SNVs, Indels and Fusions with samples run on a NextSeq 2000 instrument.

137 clinical cfDNA samples were run across 9 tumor types (lung, breast, colon, prostate, pancreatic, endometrial & cervical cancers, neuroblastoma, melanoma). Results based on clinical samples run on NextSeq 500/550/550Dx and Novaseq 6000 instruments. MSI method preliminarily trained on an additional set of 54 clinical samples.

High observed sensitivity obtained with commercial reference control cfDNA testing is corroborated with real-life cfDNA clinical samples from 11 expert cancer centers

Gene List

Tumor types: Lung Cancer, Breast Cancer, Colorectal Cancer, Thyroid Cancer, Gastrointestinal Stromal Tumors (GIST), Cholangiocarcinoma and other solid tumors.

AKT1, ALK, BRAF, EGFR, ERBB2, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, GNA11, GNAQ, GNAS, HRAS, IDH1, IDH2, KEAP1, KIT, KRAS, MAP2K1, MET, NRAS, NTRK1, NTRK2, NTRK3, PDGFRA, PIK3CA, PTEN, RET, ROS1, STK11, TP53

Ordering Information

For performance studies only, not authorized for diagnostic procedures until its clinical performance has been established and all local regulatory requirements for routine testing are met. Not available in all countries including the United States.