xT/xR
What is the % of reducing somatic false positives when doing a TNM approach with xT/xR?
28%
What is the tumor content needed for RNA and is there additional tissue required?
xR needs to report, most algos needs at least 20% tumor content to report and No additional tissue required.
Explain CtDNA
xF = Fluid strecks blood
cTDNA = floating cancer in the blood stream
Is consent needed?
Yes, consent in needed in the State of California
Whole Genome (DNA, RNA, FUSIONS)
What % of patients are found to harbor a pathogenic or likely pathogenic germline variant through xT/xR TNM?
7% ~ 1/10 patients
Explain TO and how many samples were used for the validation?
RNA expression results to predict the patient’s most likely cancer type(s) from 68 possible cancer diagnoses.
49k samples
What is the % of patients that have actionable variants found in CtDNA but not observed in solid tissue?
9%
What is the difference between xG, xG+, and xG+ RNA insight?
xG= 40 common cancers
xG+ = 77 Common and Rare Cancers
xG+/RNA = 77 Common and Rare Cancers and upgrading/downgrading a calling
Who are the main competitors for MRD?
Tumor Informed - Signatera, Foundation Tracker, RADAR (Neogenomics)
Tumor Naive - Guradant Reveal
What therapies are associated with the xT CDX? Is this gene mutated or wild type?
Explain HRD and which subtype requires higher tumor content?
HRD = Homologous recombination deficiency
The inability to repair double stranded DNA breaks via the homologous recombination repair (HRR) pathway. BRCA1/2
Breast & Ovarian: 40% tumor content with TNM
Other subtypes: 20% tumor content with NO TNM
What are the selling features for xF+?
bTMB
Tumor Fraction
MSI-H status
How can you order FVT?
Through the portal and you will need the new patients' insurance info,
If not tested within the 90 day period they will get charged.
What is needed to process?
1. Tissue from pathology
2. Initial 3 blood vials (EDTA, 2 Streck)
3. No consent needed
What are our current IHC staining offerings?
PDL1 (4 clones bonus points for naming all)
MMR
HER2 - *newly added UltraLow (0)
CLDN18 - GEJ cancers
c-MET for non-squamous NSCLC late stage
FOLR1
Explain IPS
Bonus point: What does IPS stand for?
Multimodal biomarker designed to help guide management decisions for adult patients with metastatic and/or stage IV pan-solid tumors who are already candidates for immune checkpoint inhibitor (ICI) therapy. IPS is a unique biomarker complementary to TMB, PD-L1, and MSI status.*
It may identify patients in the indicated population who are likely to have an overall survival benefit while receiving ICI therapy.
Immune profile score
What is our LOD?
0.2 for SNV and lower at the pathologists discrection
What are requirements for a patient who does not have a common or rare cancer... who wants testing?
Supplemental form - any family members who had cancer
or
Self pay $249 all xG tests or Provider Reasoning
What is the turn around time for the landmark and subsequent draws?
Landmark 4-6 weeks from time of receipt
1st subsequent draw ~12 days
Which Variant showed the greatest increase of detection when doing RNA seq in addition to DNA compared to other guideline NSCLC variants?
ROS1 by 34.1%
Published in the JAMA network
Owen D, Rotem Ben-Shachar, Feliciano J, et al. Actionable Structural Variant Detection via RNA-NGS and DNA-NGS in Patients With Advanced Non–Small Cell Lung
Cancer. JAMA Netw Open. 2024;7(11):e2442970-e2442970.
Explain HER2 Prediction Algo
The HER2 predictive algorithm uses RNA expression data to predict likelihood of HER2 positivity by IHC in order to identify patients who may benefit from confirmatory IHC HER2 testing.
Auto add on to xR reports for all subtypes except: Breast, NSCLC, CRC, Gastric, and GEJ.
How many genes are enhanced?
114
Can heme patients get tested for xG?
If it is not active
What is the LOD?
Limit of Detection is 95.
LOD 95 - is where we can reliably detect CtDNA in the blood sample ~ 4PPM
& LOD50 - the detection threshold of how often we see CtDNA ~ 1.67 PPM