How does Caris measure ALK/ROS1/MET/RET and why is this technology a better choice?
RNAseq.
Compared to DNA sequencing, used by most other companies, RNA sequencing will better frame the therapeutic significance of the translocation/fusion found.
100
Why does Caris repeat ER, PR and HER 2 tests when they have already been performed on the primary tumor?
Because the status of these biomarkers can change with disease progression.
CMI can identify new potential treatment options.
100
What is the clinical definition of platinum resistance?
Disease recurrence within 6 months of completion of platinum based chemotherapy.
CMI can help guide the next therapy after recurrence.
100
What technology/biomarkers does Caris use to test for Lynch Syndrome?
Caris uses IHC to test for mismatch repair (MMR) deficiency which includes, MLH1, MSH2, MSH6, PMS2, and fragment analysis to test for MSI.
100
In addition to NSCLC, name at least 3 other lineages where PD L1 inhibitors have been approved.
Bladder, Kidney, Head and Neck, Melanoma
200
What exons in the EGFR gene are most important for targeted therapy?
Exons 18-21
Caris analyzes the full gene and pathway to identify all variables that could impact response to anti-EGFR therapies. Some other companies only analyze 19-21 with PCR.
200
What 3 technologies does Caris use to determine HER 2 status in breast cancer, and why is this important?
NGS/IHC/ISH
To rule out equivocal HER2 status.
200
Name at least 1 of the 2 current FDA approved PARP inhibitors for recurrent ovarian cancer?
Lynparza/Olaparib
Rubraca/Rucaparib
200
NCCN guidelines suggest testing for what 3 biomarkers in mCRC?
KRAS, NRAS, BRAF
Caris performs all of these.
200
What is the most common mutation in pancreatic cancer, and why would an oncologist send for CMI on a newly diagnosed patient?
KRAS
There is no defined standard of care for these patients and the "first shot is the best shot"
300
Name the technologies used by Caris to measure EGFR mutations and how would you position this to an oncologist?
NGS /IHC/RFLP.
Caris makes every attempt to get this critical result. When tissue is limited, Caris is one of the only companies that offers these reflex options to avoid QNS results.
300
What is the response rate for Herceptin on HER2 positive breast cancer? Why is this important?
40%
Targeted therapies are not the "silver bullet". CMI can offer additional beneficial options for non-responders, and rule out resistant drugs.
300
In the Herzog study, patients in the matched cohort had a higher median overall survival advantage of how many months, compared to the unmatched cohort?
9 months
300
Name at least 2 IHC biomarkers and their associated drugs in the colon panel.
ERCC1 /oxaliplatin
TOPO1/irinotecan
TS/ 5-FU or capcitabine
These associations could not be made from DNA analysis alone.
300
What is an important biomarker not tested by Foundation Medicine for Glioma patients, and what testing platform does Caris use to measure?
MGMT Methylation
Pyrosequencing
400
What percentage of NSCLC patients are ALK positive?
2-7%.
Because this is such a small percentage, as are the other lung specific mutations, a more comprehensive profile, which includes protein analysis, delivers much more clinical utility.
400
What was the overall response rate for women who received MP guided treatment in the Jameson (Sideout) study?
44% (11/25) which is remarkable considering an average of 7 prior therapies.
400
What is the companion diagnostic / assay for Rubraca(Rucaparib)? How would you position CMI?
BRCA / Foundation Focus CDx assay.
CMI is very comparable to the CDx assay for BRCA, as they both detect somatic mutations from tissue samples. Furthermore, CMI will be able to provide additional biomarker information beyond BRCA to help determine next therapy.
400
What therapy is approved for the treatment for MSI H colon cancer?
New data indicates that MSI H colorectal cancer patients are good candidates for the immune checkpoint therapies
Keytruda (Pembrolizumab) and Opdivo (Nivolumab)
400
What is the newest class of drugs for castration resistant prostate cancer, and what is the corresponding biomarker?
How often and when does a T790M mutation occur? What is the significance?
It occurs 50% of the time when there is disease progression after treatment with and anti-EGFR agent.
There are now targeted therapies( Tagrisso)
Caris identifies this mutation.
500
What has changed in the latest NCCN guidelines for breast cancer with regards to BRCA testing?
BRCA mutation detected by tumor profiling in the absence of germline analysis warrants further personalized risk assessment, genetic counseling and genetic testing.
500
What is chemosensitivity and how is CMI different?
Chemosensitivity is a test performed in vitro that measures the number of tumor cells killed only by specific lineage related chemotherapies.
CMI looks at biomarkers within the tumor and makes drug associations based on established clinical data for all tumor types.
500
This IHC biomarker is associated with reduced benefit to EGFR targeted monoclonal antibodies
PTEN
500
What is the technology Caris utilizes to determine MSI status and in what 2 tumor types does this drive therapy?