# Invitae Common Hereditary Cancers Panel

Source: https://onco.cc/drugs/invitae-common-hereditary-cancers-panel/  
OnCo record `invitae-common-hereditary-cancers-panel` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A blood test of 47 genes, authorised by the US regulator and ordered by a clinician, that finds inherited changes which raise cancer risk or explain a cancer already diagnosed.

## Summary

Granted by the FDA through the De Novo pathway on 29 September 2023 (DEN210011, received 29 March 2021), creating the device type 'high throughput DNA sequencing for hereditary cancer predisposition assessment' (21 CFR 866.6095, product code QVU). Intended use: prescription, for hereditary cancer predisposition assessment in accordance with professional guidelines and to aid in identifying hereditary variants potentially associated with a diagnosed cancer; not for cancer screening or prenatal testing; a single-site assay performed at Invitae. The 47 genes include APC (with the 1B promoter), BRCA1, BRCA2, PALB2, the Lynch genes (MLH1, MSH2 with the exon 1 to 7 inversion, MSH6, PMS2, EPCAM by copy number only), CDH1, CTNNA1, STK11, SMAD4, BMPR1A, MUTYH, NTHL1, POLE, POLD1, TP53, PTEN, NF1, TSC1, TSC2, VHL, the SDH genes, CDKN2A, CDK4, HOXB13 and GREM1 (promoter duplication only). The Genetic Testing Registry entry for the panel (GTR000528518.4, last updated in 2017) lists an earlier 42-gene version. Labcorp bought select Invitae assets in 2024.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Tags: test; hereditary
- Brand: Invitae Common Hereditary Cancers Panel
- Modality: Germline hereditary cancer sequencing panel test (FDA De Novo)
- Mechanism: High-throughput sequencing of germline DNA from whole blood for substitutions, small insertions and deletions and copy number variants in 47 genes, with variants classified by laboratory professionals.
- Approvals: US 2023: Hereditary cancer predisposition assessment and identification of hereditary variants potentially associated with a diagnosed cancer (De Novo DEN210011, prescription use)

## Notes

- What a result means: a pathogenic variant in one of the genes changes screening, risk-reducing surgery or treatment for the patient and allows relatives to be tested; a variant of uncertain significance should not change care.

## Sources

- FDA De Novo DEN210011: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210011
- FDA decision summary DEN210011 (PDF): https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN210011.pdf
- NIH Genetic Testing Registry GTR000528518.4: https://www.ncbi.nlm.nih.gov/gtr/tests/528518/

## Connected records

- technologies: [Germline (hereditary) testing](https://onco.cc/technologies/germline-testing/)
- targets: [APC](https://onco.cc/targets/apc/), [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [CDH1](https://onco.cc/targets/cdh1/), [MLH1](https://onco.cc/targets/mlh1/), [MSH2](https://onco.cc/targets/msh2/), [MSH6](https://onco.cc/targets/msh6/), [MUTYH](https://onco.cc/targets/mutyh/), [NF1 (neurofibromin)](https://onco.cc/targets/nf1/), [PALB2](https://onco.cc/targets/palb2/), [PMS2](https://onco.cc/targets/pms2/), [STK11](https://onco.cc/targets/stk11/), [TP53](https://onco.cc/targets/tp53/)
- companies: [Invitae](https://onco.cc/companies/invitae/)
- terms: [Gastric adenocarcinoma and proximal polyposis of the stomach (GAPPS)](https://onco.cc/terms/gapps/), [Hereditary cancer syndromes](https://onco.cc/terms/hereditary-cancer-syndromes/), [Hereditary diffuse gastric cancer](https://onco.cc/terms/hereditary-diffuse-gastric-cancer/), [Juvenile polyposis syndrome](https://onco.cc/terms/juvenile-polyposis-syndrome/), [Li-Fraumeni syndrome (germline TP53)](https://onco.cc/terms/li-fraumeni/), [Lynch syndrome](https://onco.cc/terms/lynch-syndrome/), [MUTYH-associated polyposis](https://onco.cc/terms/mutyh-associated-polyposis/), [Peutz-Jeghers syndrome](https://onco.cc/terms/peutz-jeghers-syndrome/), [Variant of uncertain significance (VUS)](https://onco.cc/terms/vus/)
- drugs: [Invitae Multi-Cancer Panel](https://onco.cc/drugs/invitae-multi-cancer-panel/)

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