Download GRID Analysis Patient Report RUO result

GenomeDx Biosciences Laboratory
10355 Science Center Dr. Suite 240, San Diego, CA 92121
Tel: 1-888-792-1601 | Fax: 1-855-324-2768
[email protected] | www.genomedx.com
Patient Details
Order Information
Patient Name:
Order Date:
GRID Analysis
Patient Report!
Specimen Received Date:
Medical Record Number:
Date of Birth:
GenomeDx Accession ID:
Patient Name: DEC1234
Date of Prostatectomy:
____________________________________________________________
!Report Date: Sept 21, 2015!
Specimen ID:
Ordering Physician:
FOR RESEARCH USE
ONLY*!
Clinic/Hospital
Name:
Pathology Laboratory:
Pathologist:
Patient Details!
Pathologist Address:
Patient Name: SAMPLE!
Clinical
Date of Birth:
NA!Details
Pre-operative PSA (ng/mL):
Date of Prostatectomy:
NA!
Gleason Score:
Medical Record
Number: NA!
!
Your Decipher Result:
Clinic/Hospital Address:
RUO GRID information:!
Additional Physician:
Decipher® Accession ID: DEC1234!
!
Ordering
Dr. Urologist!
EPE Physician:
SVI
SM+
LNI
BCR
Clinic/Hospital
Name:
Urology Inc!
Other:
Clinic/Hospital Address:!
Genomic! high risk
*Decipher GRID is a whole genome array analysis: This
Report isrisk
forresult:
Research
Use Only
YourAnalysis
Decipher genomic
Independent
of
(RUO) and is not intended as an aid to clinical decision
making
!
clinical
risk factors,
your five year Decipher genomic
RUO result – implicated markers*!
Marker!
Genomic Event!
SPINK-1!
CD274!
Positive!
Over-expression!
risk of metastasis after radical prostatectomy is
21.8%. Your Decipher risk is 3.6 times the average*
patient with adverse pathology.
Interpretation: Clinical studies concluded that
Decipher high risk men with adverse pathology have
Implicated
Pathway!
a poor prognosis
overall.1-3 These
men may benefit
from adjuvant or early salvage radiotherapy and
consideration for clinical trials.4-6
EGFR !
PD-1 !
Relevant findings from published clinical studies: Patients with
Decipher high risk had 77% 5 year metastasis-free survival and
70% 10 year cancer-specific survival.1,3 For these patients there
was improved metastasis-free survival favoring adjuvant and early
salvage postoperative radiotherapy.4-6
In patients with PSA rise or biochemical recurrence after surgery
that received salvage radiotherapy, only 66.5% remained
metastasis-free after 5 years.6
The Decipher risk reported here has a 95% confidence interval of
20.0% to 42.4%.
References on reverse
*Average clinical risk refers to the average cohort risk of clinically high-risk men post surgery, established in a cohort of 1,010 clinically high-risk patients that received radical prostatectomy as first line treatment at the Mayo Clinic between 2000 and 2006. The average incidence of metastasis was 6.0% at 5 years post radical prostatectomy.
5-year Predicted Probability of Clinical Metastasis: a genomic risk score is derived by measuring the RNA expression of 22 biomarkers in a primary prostate adenocarcinoma specimen
(Erho et al., 2013). Decipher uses the genomic risk score to predict the 5-year probability for developing clinical metastasis; using a cox-proportional hazards survival model based upon
a cohort of 1,010 clinically high-risk patients with 6.9 median years of follow-up (Karnes et al., 2013). Decipher probabilities range between 0% and 100%. Decipher risk categories are
determined from an optimized statistical model, representing significantly distinct metastatic risk (hazard ratios) between the risk categories. Relative risk is calculated as a ratio of the
patient’s Decipher probability as compared to the 6.0% average risk of clinical metastasis observed in this population of clinically high-risk men.
GenomeDx Medical Director (Name & Signature)
Medical Directors:
Timothy J. Triche, MD PhD • Doug Dolginow, MD
Date
Disclaimer: The Decipher test was developed and its performance characteristics were determined by
GenomeDx Biosciences Laboratory. The GenomeDx Biosciences Laboratory is certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA ‘88) to perform high complexity testing. This test has
not been cleared or approved by the U.S. Food and Drug Administration. Summary of surgical pathology
report is provided for convenience of Ordering Physician. Please refer to Referring Pathologist’s original
pathology report to guide treatment decisions.
*A complete list of the markers assayed & their researchCopyright
implications
can
be found
© GenomeDx
Biosciences
Inc. on page 2 of this report!
CLIA ID# 05D2055897
Page 1 of 2
Page 1 of 2!
GenomeDx Biosciences Laboratory
10355 Science Center Dr. Suite 240, San Diego, CA 92121
Tel: 1-888-792-1601 | Fax: 1-855-324-2768
[email protected] | www.genomedx.com
Patient Details
Order Information
Patient Name:
Order Date:
GRID Analysis
Patient Report!
Specimen Received Date:
Medical Record Number:
Date of Birth:
Marker!
Patient Name:
Date of Prostatectomy:
____________________________________________________________
Biological
Pathology
Laboratory:
Context!
Pathologist:
Genomic
Event*!
SPINK1! Pathologist
Intrinsic
Address:
Subtype!
Positive!
Clinical Details
Pre-operative PSA (ng/mL):
Gleason Score:
CD274!
Immune
!
Specimen ID:
!Report Date: !
Ordering Physician:
Percentile
Rank**!
NA!
GenomeDx Accession ID:
Relevant Research Findings!
Clinic/Hospital Name:
Clinic/Hospital Address:
Over-expression
of SPINK1 has been shown to be associated
Additional Physician:
with poor outcome in ERG- prostate cancer patients,
especially in men with African-American ancestry. In vitro
studies suggest
that SVI
SPINK1SM+
positive
prostate
cancer growth
EPE
LNI
BCR
is sensitive to EGFR inhibitors such as cetuximab6!
Other:
Over-
93rd!
PD-L1/PD-1-mediated T cell co-inhibition is involved in
Your
Decipher
Result: Genomic
Checkpoint!
expression!
immune high
evasion risk
in prostate cancer. Over-expression of PDL1
by cancer cells may enable tumors to evade T cell immune
responses. Over-expression of PDL1 is correlated to greater
Your
genomic
12! risk result: Independent of
responses
to Decipher
anti-PD1 therapy
clinical risk factors, your five year Decipher genomic
risk of metastasis after radical prostatectomy is
21.8%. Your Decipher risk is 3.6 times the average*
patient with adverse pathology.
Interpretation: Clinical studies concluded that
*Intrinsic subtypes are defined by outlier expression (e.g., either positive or negative).
High
or low
expression
areadverse
defined bypathology
1 standard deviation
Decipher
high
risk
men with
have
greater or lower than the mean of the GRID population (n=1,683).!
a poor prognosis overall.1-3 These men may benefit
**Percentile rank indicates the percentage of patient tumors in the GRID (n=1,683) with lower scores than your tumor’s expression!
Genomic markers assayed in Decipher GRID!
from adjuvant or early salvage radiotherapy and
consideration for clinical trials.4-6
Relevant findings from published clinical studies: Patients with
Decipher
highbelow
risk had
77% 5 yearthe
metastasis-free
and
Decipher GRID analyses ~44,000 coding and non-coding genes.
The list
represents
biomarkerssurvival
currently
70% 10 year cancer-specific survival.1,3 For these patients there
evaluated for their prognostic & predictive power in prostate cancer.
Decipher GRID will be updated as new markers
was improved metastasis-free survival favoring adjuvant and early
are studied and evaluated.!
salvage postoperative radiotherapy.4-6
Proliferation!
Metastasis/
Invasion!
Intrinsic
Subtypes!
In patients withNeuroendocrine
PSA rise or biochemical
recurrence
after surgery
Androgen
/
Immune
that received Small
salvage
radiotherapy, only Checkpoint!
66.5% remained
Signaling!
Cell!
6
Ki-671,2!
SChLAP13.4!
ERG1,2,6!
8!
AR1! The Decipher risk
NEAT1
B7-H32,11!
reported here has a 95% confidence
interval of
TOP2A1,2!
SPARCL15!
ETV12,6!
PSA2!
Cyclin D19!
PD112!
ETV46,7!
NKX3-11!
pRB1,10!
PDL112!
6!
metastasis-free after 5 years.
20.0% to 42.4%.
References on reverse
1,2,7!
2!
PCA3
Chromogranin
A patients that received radical prostatec*Average clinical risk refers to the average cohortETV5
risk of clinically high-risk men post
surgery, established in a cohort
of 1,010 clinically high-risk
tomy as first line treatment at the Mayo Clinic between 2000 and 2006. The average incidence of metastasis was 6.0% at 5 years post radical prostatectomy.
SPINK16!
5-year Predicted Probability of Clinical Metastasis: a genomic risk score is derived by measuring the RNA expression of 22 biomarkers in a primary prostate adenocarcinoma specimen
(Erho et al., 2013). Decipher uses the genomic risk score to6 predict the 5-year probability for developing clinical metastasis; using a cox-proportional hazards survival model based upon
FLI1
a cohort of 1,010 clinically high-risk patients with 6.9
median! years of follow-up (Karnes et al., 2013). Decipher probabilities range between 0% and 100%. Decipher risk categories are
determined from an optimized statistical model, representing significantly distinct metastatic risk (hazard ratios) between the risk categories. Relative risk is calculated as a ratio of the
GenomeDx References:!
patient’s Decipher probability as compared to the 6.0% average risk of clinical metastasis observed in this population of clinically high-risk men.
1.  Yamoah, et al. Novel biomarker signature that may predict aggressive disease in African-American men with prostate cancer. Journal of Clinical Oncology, 2015; DOI: 10.1200/JCO.2014.59.8912.!
2.  Erho, N., et al., Discovery and Validation of a Prostate Cancer Genomic Classifier that Predicts Early Metastasis
Following
PLoS
One. 2013
Jun 24;8(6):e66855.!
Disclaimer: The
DecipherRadical
test wasProstatectomy.
developed and its
performance
characteristics
were determined by
3.  Prensner, et al. RNA biomarkers associated with metastatic progression in prostate cancer: a multi-institutional
analysis
of SChLAP1,Lancet
Oncology,is2014,
GenomeDxhigh-throughput
Biosciences Laboratory.
The GenomeDx
Biosciences Laboratory
certified15(13):1469-80!
under the Clinical
Laboratory
Improvementcomplex,
Amendments
of 1988
(CLIA ‘88)2013,
to perform
high complexity testing. This test has
4.  Prensner, et al. The long noncoding RNA SChLAP1 promotes aggressive prostate cancer and antagonizes
the SWI/SNF
Nature
Genetics,
45(11):1392-8!
not beenprostate
cleared orcancers
approvedand
by the
U.S. Food and
Summary
of surgical
5.  Hurley, et al., Secreted protein, acidic and rich in cysteine-like 1 (SPARCL1) is down regulated in aggressive
is prognostic
forDrug
poorAdministration.
clinical outcome,
PNAS,
2012,pathology
109(37):
Date
14977-82! GenomeDx Medical Director (Name & Signature)
report is provided for convenience of Ordering Physician. Please refer to Referring Pathologist’s original
6.  Tomlins, et al. Characterization of 1577 Primary Prostate Cancers Reveals Novel Biological and Clinicopathologic
Insights
into
Molecular
Subtypes,
Eur
Urology,
2015!
pathology report to guide treatment decisions.
Medical
Directors:
7.  Aytes, et al. ETV4
promotes
metastasis in response to activation of PI3-kinase and Ras signaling in a mouse model of advanced prostate cancer. PNAS, 2013,110(37):E3506-15 !
Timothy
J.
Triche,
MD
PhD
•
Doug
Dolginow,
MD
8.  Chakravaty, et al. The oestrogen receptor alpha-regulated lncRNA NEAT1 is a critical modulator of prostate cancer, Nature Comm , 2014, 21;5:5383!
9.  Tsai, et al., Cyclin D1 Loss Distinguishes Prostatic Small Cell Carcinoma from Most Prostatic Adenocarcinomas, Clinical Cancer Research, 2015,!
CLIA ID# 05D2055897
10. Tan,et al., Rb loss is characteristic of prostatic small cell neuroendocrine carcinoma, Clinical Cancer Research, 2014, 20(4):890-903!
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11. Chavin, et al. Expression of immunosuppresive B7-H3 ligand by hormone-treated Copyright
prostate cancer
tumors Biosciences
and metastases.
© GenomeDx
Inc. Clinical Cancer Research, 2009,15(6):2174-80!
12. Zitvogel and Kroemer, Targeting PD-1/PD-L1 interactions for immunotherapy, Oncoimmunology, 2012,1(8):1223-1225 !
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