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OnkoHRDTM

GenPath® Oncology, now offers OnkoHRDTM homologous recombination deficiency (HRD) assessment with OnkoSight AdvancedTM next-generation sequencing (NGS).

  • Measure genomic scars, which are defined by signal large-scale genomic instability, such as loss of heterozygosity (LOH), telomeric allelic imbalance (TAI), and large-scale state transitions (LST) in addition to the sequencing of the critical genes involved in the homologous recombination repair (HRR) pathway (e.g., BRCA1, BRCA2).
  • Detect abnormalities across the genome, thereby expanding access to HRD status assessment of cancer samples.
  • Interrogate CCNE1 Amplification status, a predictive biomarker for therapy resistance in epithelial ovarian cancer.

Per NCCN®, somatic testing in ovarian cancer should at a minimum include BRCA1/2, loss of heterozygosity (LOH), or HRD status in the absence of a germline BRCA mutation.

In ovarian cancers, HRD serves as a predictive biomarker for PARP inhibitors and a positive prognostic marker for both progression-free survival and overall survival.

FDA-Approved PARP Inhibitors Requiring HRD and/or HRR Gene Mutation Status: 

TUMOR TYPE THERAPY GENPATH® TEST OPTION*
 

Ovarian cancer

 Olaparib (Lynparza®)

Niraparib (Zejula®)

Rucaparib (Rubraca®)

 TH53-1 OnkoSight AdvancedTM Gynecologic Neoplasms Panel

TJ16-5 OnkoSight AdvancedTM Solid Tumor Panel

TM57-2 OnkoSight Advanced CompleteTM with PierianDx Interp
 

Breast cancer

 Olaparib (Lynparza®)

Talazoparib (Talzenna®)

 TP57-6 OnkoSight AdvancedTM Breast Cancer Panel

TJ16-5 OnkoSight AdvancedTM Solid Tumor Panel

TM57-2 OnkoSight Advanced CompleteTM with PierianDx Interp
 

Prostate cancer

 Talazoparib (Talzenna®)

Rucaparib (Rubraca®)

 TH48-2 OnkoSight AdvancedTM Prostate Cancer Panel

TJ16-5 OnkoSight AdvancedTM Solid Tumor Panel

TM57-2 OnkoSight Advanced CompleteTM with PierianDx Interp
 

Pancreatic cancer

  

Olaparib (Lynparza®)

 TK84-0 OnkoSight AdvancedTM Pancreaticobiliary Tumor Panel

TJ16-5 OnkoSight AdvancedTM Solid Tumor Panel

TM57-2 OnkoSight Advanced CompleteTM with PierianDx Interp
Clients may add TQ30-1 OnkoHRDTM to any OnkoSight AdvancedTM Panel listed in this table.

Please visit U.S. Food & Drugs website https://www.fda.gov/ to view full prescribing information of the abovementioned therapies.

*Includes somatic test options only. GenPath also offers OnkoRiskTM hereditary cancer testing. Please visit www.genpath.com to view GenPath’s comprehensive test offerings. Healthcare providers should only order panels if each gene or test in the panel is medically necessary and appropriate.

Test Information

TQ30-1

NOTE: An OnkoSight AdvancedTM Solid Tumor Panel must be ordered to run OnkoHRD.

TH53-2

AKT1
AR
ATM
BRAF
BRCA1
BRCA2
BRIP1
CCNE1
CDH1
CDK12
CHEK1
CHEK2
EGFR
EPCAM
ERBB2
ERBB3
ESR1
FANCA
FANCC
FANCL
FGFR1
FGFR2
FOXA1
KRAS
MLH1
MRE11A
MSH2
MSH6
MUTYH
NBN
MYC
NF1
PALB2
PIK3CA
PMS2
POLE
PTEN
RAD50
RAD51B
RAD51C
RAD51D
RAD54L
RB1
RECQL4
SLX4
SMARCA4
TBX3
TERT
TP53
XRCC2

TP57-6

AKT1
AR
ATM
ATR
ATRX
BARD1
BRAF
BRCA1
BRCA2
BRIP1
CCNE1
CDH1
CDK12
CHEK1
CHEK2
EGFR
EPCAM
ERBB2
ERBB3
ERBB4
ESR1
FANCA
FANCC
FANCL
FGFR1
FGFR2
FOXA1
KRAS
MLH1
MRE11A
MSH2
MSH6
MUTYH
MYC
NBN
PALB2
PIK3CA
PMS2
PTEN
RAD50
RAD51
RAD51B
RAD51C
RAD51D
RAD54L
RB1
RECQL4
TERT
TP53
XRCC2

TH48-2

AKT1
AR
ARID1A
ATM
ATR
BARD1
BRAF
BRCA1
BRCA2
BRIP1
CCND1
CCNE1
CDK12
CHD1
CHEK1
CHEK2
CTNNB1
EPCAM
FANCA
FANCL
FANCD2
FAM175A
FOXA1
FOXO1
GEN1
HOXB13
HRAS
IDH1
MLH1
MRE11A
MSH2
MSH6
MUTYH
MYC
NBN
NTRK1
PALB2
PIK3CA
PMS2
PPP2R2A
PTEN
RAD51B
RAD51C
RAD51D
RAD54L
RB1
SPOP
TERT
TP53

TK84-0

ARID1A
BRAF
BRCA1
BRCA2
CCNE1
ERBB2
FGFR1
FGFR2
FGFR3
IDH1
IDH2
KRAS
MLH1
MSH2
MSH6
NRAS
PALB2
PIK3C2G
PMS2
STK11
TGFBR2
TP53
VHL

TJ16-5

AKT1
APC
ARID1A
ATM
BRAF
BRCA1
BRCA2
CDH1
CDKN2A
CTNNB1
EGFR
EPCAM
ERBB2
ERBB4
FBXW7
FGFR1
FGFR2
FGFR3
GNA11
GNAQ
GNAS
HRAS
IDH1
IDH2
KDR
KIT
KRAS
MEN1
MET
MLH1
MSH2
MSH6
NOTCH1
NRAS
PDGFRA
PIK3CA
PMS2
POLE
PTEN
PTPN11
RB1
RET
SMAD4
SMO
STK11
TERT
TSC1
TSC2
TP53
VHL

TM57-2

Visit www.genpathdiagnostics.com/onkosight-advanced-complete/ to view the panel components

^Virtual karyotyping or CNA assessment will require samples with >50% tumor content. Normal findings will not be reported. For TJ16, CNA assessment will be performed on samples with an indication for tumor subtypes with HRD- associated therapy including high-grade serous ovarian (HGSO), fallopian tube, primary peritoneal, prostate, breast, and pancreaticobiliary carcinoma.

References:

  1. Stewart MD, Merino Vega D, Arend RC, Baden JF, Barbash O, Beaubier N, Collins G, French T, Ghahramani N, Hinson P, Jelinic P, Marton MJ, McGregor K, Parsons J, Ramamurthy L, Sausen M, Sokol ES, Stenzinger A, Stires H, Timms KM, Turco D, Wang I, Williams JA, Wong-Ho E, Allen Homologous Recombination Deficiency: Concepts, Definitions, and Assays. Oncologist. 2022 Mar 11;27(3):167-174. doi: 10.1093/oncolo/oyab053. PMID: 35274707; PMCID: PMC8914493.
  2. Rempel E, Kluck K, Beck S, Ourailidis I, Kazdal D, Neumann O, Volckmar AL, Kirchner M, Goldschmid H, Pfarr N, Weichert W, Hübschmann D, Fröhling S, Sutter C, Schaaf CP, Schirmacher P, Endris V, Stenzinger A, Budczies Pan- cancer analysis of genomic scar patterns caused by homologous repair deficiency (HRD). NPJ Precis Oncol. 2022 Jun 9;6(1):36. doi: 10.1038/s41698-022-00276-6. PMID: 35681079; PMCID: PMC9184602.
  3. Gou R, Dong H, Lin B. Application and reflection of genomic scar assays in evaluating the efficacy of platinum salts and PARP inhibitors in cancer therapy. Life Sci. 2020 Nov 15;261:118434. doi: 10.1016/j.lfs.2020.118434. Epub 2020 Sep 14. PMID: 32941897.
  4. NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer 2.2023- June 2, 2023. Accessed 7.26.2023
  5. Quesada S, Fabbro M, Solassol J. Toward More Comprehensive Homologous Recombination Deficiency Assays in Ovarian Cancer, Part 1: Technical Considerations. Cancers (Basel). 2022 Feb 23;14(5):1132. doi: 10.3390/ PMID: 35267439; PMCID: PMC8909526.