ProstateNext

Since hereditary prostate cancer is not well understood or often recognized, clinicians need clear results to guide treatment decisions. ProstateNext is a 14-gene panel which offers more precision to identify and manage hereditary prostate cancer. 

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Quick Reference
Test Code 8845
Turnaround Time (TAT) 14-21 days
Number of Genes 14
Specimen Requirements Click here

Ordering Options

Why Is This Important?

  1. Option to modify frequency and initial age of prostate cancer screening
  2.  Consideration of risk-reducing measures for your patient and/or their family members
  3.  Option to tailor treatments (e.g. PARP inhibitors for prostate cancer patients who have ATM or BRCA1/BRCA2 mutations)
  4.  Identify at-risk family members

When To Consider Testing

  • Early-onset prostate cancer (diagnosed <50 years of age)
  • Metastatic prostate cancer at any age
  • Multiple primary cancers in one person (e.g. prostate and male breast cancer)
  • Personal history of prostate cancer and >1 family members* with breast cancer (<50 years of age) and/or invasive ovarian cancer
  • Personal history of prostate cancer and >2 family members* with breast, pancreatic, or prostate cancer      

* On the same side of the family

Mutation Distribution and Detection Rates*

* Excludes MUTYH carriers, APC p.l1307K, and CHEK2 p.l157T

Test Description

ProstateNext analyzes 14 genes (listed above). 13 genes (excluding EPCAM) are evaluated by next generation sequencing (NGS) or Sanger sequencing of all coding domains, and well into the flanking 5’ and 3’ ends of all the introns and untranslated regions. In addition, sequencing of the promoter region is performed for the following genes: MLH1 (c.-337 to c.-194), and MSH2 (c.-318 to c.-65). The inversion of coding exons 1-7 of the MSH2 gene and the BRCA2 Portuguese founder mutation, c.156_157insAlu (also known as 384insAlu) are detected by NGS and confirmed by PCR and agarose gel electrophoresis. Clinically significant intronic findings beyond 5 base pairs are always reported. Intronic variants of unknown or unlikely clinical significance are not reported beyond 5 base pairs from the splice junction. Additional Sanger sequencing is performed for any regions missing or with insufficient read depth coverage for reliable heterozygous variant detection. Reportable small insertions and deletions, potentially homozygous variants, variants in regions complicated by pseudogene interference, and single nucleotide variant calls not satisfying 100x depth of coverage and 40% het ratio thresholds are verified by Sanger sequencing. Gross deletion/duplication analysis is performed for the covered exons and untranslated regions of all 14 genes using read-depth from NGS data with confirmatory multiplex ligation-dependent probe amplification (MLPA) and/or targeted chromosomal microarray. If a deletion is detected in exons 13, 14, or 15 of PMS2, double stranded sequencing of the appropriate exon(s) of the pseudogene, PMS2CL, will be performed to determine if the deletion is located in the PMS2 gene or pseudogene.

 

1. Mu W, et al. Sanger confirmation is required to achieve optimal sensitivity and specificity in next-generation sequencing panel testing. J Mol Diagn. 2016. 18(6):923-932.

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