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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.
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.
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. Connects to BRCA1 / BRCA2 (HRD), PALB2, MLH1, MSH2, MSH6, PMS2, CDH1, STK11, MUTYH, TP53, APC and NF1 (neurofibromin).
De Novo DEN210011 granted; new regulation 21 CFR 866.6095, product code QVU. source
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Hereditary cancer predisposition assessment and identification of hereditary variants potentially associated with a diagnosed cancer (De Novo DEN210011, prescription use) |
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Query for this drug: (TITLE:"Invitae Common Hereditary Cancers Panel" OR ABSTRACT:"Invitae Common Hereditary Cancers Panel") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Invitae Common Hereditary Cancers Panel, not a curated reading list.
Shares Juvenile polyposis syndrome, MUTYH, Peutz-Jeghers syndrome, CDH1 and the tags test, hereditary.
Shares MSH6, PMS2, Variant of uncertain significance (VUS), MSH2 and the tags test, hereditary.
Shares Hereditary diffuse gastric cancer, CDH1, MSH2, MLH1 and the tags test, hereditary.
Shares Hereditary diffuse gastric cancer, CDH1, NF1 (neurofibromin), PALB2 and the tags test, hereditary.
Shares Peutz-Jeghers syndrome, MSH2, MLH1, PALB2 and the tags test, hereditary.
Shares MSH2, MLH1, PALB2, Lynch syndrome and the tags test, hereditary.
Shares MSH2, MLH1, PALB2, Lynch syndrome and the tags test, hereditary.
Shares MUTYH-associated polyposis, MUTYH, Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
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