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Hereditary Cancer Screen

A 48-gene screening test for hereditary cancer predisposition across breast, gynecologic, prostate, and gastrointestinal systems, powered by the Helix Exome+® platform.

Turnaround

6-21 days

Requery (SOQO)

≤ 5 days

Genes Tested

48

Panel Description

Helix Hereditary Cancer Screen is a screening test that analyzes 48 genes associated with hereditary cancer conditions that predispose to a variety of primarily adult-onset solid tumors across many organ systems including: breast, gynecologic (ovarian and uterine), prostate, and those in the gastrointestinal system. This test only reports clinically significant pathogenic and likely pathogenic variants but does not report variants of uncertain significance (VUS).

Order This Test

Contact our clinical team to order this panel or learn more.

(855) 699-1933
clinicalsupport@helix.com

Indications for Testing

This is a screening test and therefore is not recommended for individuals with a personal and/or family history suggestive of one of the associated conditions. Early detection and/or intervention for the conditions tested here could significantly reduce morbidity and mortality.

Methodology

This test utilizes next-generation sequencing to detect single nucleotide variants, insertions and deletions up to 20 bp, and copy number variants in genes associated with hereditary conditions predisposing to cancers including: breast, gynecologic (ovarian and uterine), prostate, and those in the gastrointestinal system.

Technical Specifications

Analytical sensitivity (SNV)

> 99%

Analytical sensitivity (indel)

> 99%

Analytical specificity

> 99%

CNV sensitivity (multi-exon)

> 99%

CNV sensitivity (single-exon)

> 90%

Gene notes

APC: analysis includes CNV of promoters 1A and 1B and sequencing of promoter 1B; BMPR1A: analysis includes CNV of promoter; BRCA1: sequencing analysis extends to CDS +/-20 bp; BRCA2: analysis includes detection of c.156_157insAlu and sequencing analysis extends to CDS +/-20 bp; CDKN2A: analysis includes sequencing of the p16 (p16INK4a) and p14 (p14ARF) transcripts; EPCAM: analysis is limited to CNV of exons 8-9; GREM1: analysis is limited to CNV of the promoter; HOXB13: analysis is limited to the c.251G>A (p.Gly84Glu) variant; MLH1: analysis includes CNV of the promoter; MSH2: analysis includes detection of the Boland inversion (inversion of exons 1-7) and detection of c.942+3A>T; MSH3: analysis excludes sequencing of exon 1 repeat region; PMS2: analysis is limited to exons 1-10; POLD1: CNV analysis is not performed and sequencing is limited to the 3'-5' exonuclease domain; POLE: CNV analysis is not performed and sequencing is limited to the 3'-5' exonuclease domain; PTEN: analysis includes CNV of the promoter; SDHA: analysis excludes CNV; STK11: sensitivity of exon 3 analysis may be reduced; TP53: analysis includes CNV of the promoter; TSC1: sensitivity of exon 21 analysis may be reduced; VHL: analysis excludes coverage of the cryptic E1' exon

Genomic build

GRCh38

Genes Tested

48 genes included in this panel

APCATMAXIN2BAP1BARD1BMPR1ABRCA1BRCA2BRIP1CDH1CDK4CDKN2ACHEK2CTNNA1DICER1EPCAMFHGREM1HOXB13KITMBD4MEN1MLH1MSH2MSH3MSH6MUTYHNF1NTHL1PALB2PDGFRAPMS2POLD1POLEPTENRAD51CRAD51DSDHASDHBSDHCSDHDSMAD4SMARCA4STK11TP53TSC1TSC2VHL

Ordering Information

Turnaround Time

Typically 6-21 days (standard), Typically ≤ 5 days (requery)

Preferred Specimen

BD Vacutainer Whole Blood K2 EDTA Collection Tube 4mL or Oragene Dx Saliva Collection Kit

Shipping Instructions

Specimens to arrive at Helix within 96 hours of collection at ambient temperature.

Clinical Description

Helix Hereditary Cancer Screen is a screening test that analyzes 48 genes associated with hereditary cancer conditions that predispose to a variety of primarily adult-onset solid tumors across many organ systems including: breast, gynecologic (ovarian and uterine), prostate, and those in the gastrointestinal system. This test only reports clinically significant pathogenic and likely pathogenic variants but does not report variants of uncertain significance (VUS).

Ready to order this test?

Contact our clinical team to order the Hereditary Cancer Screen for your patients.