Clinical Data in Over 1,500 Patients Across All Stages of ... · (%CV) Intra-Assay 19.1%...
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Clinical Data in Over 1,500 Paents Across All Stages of Breast Cancer with Target Selector™ Circulang Tumor Cell Technology Julie Ann Mayer Ph.D., Deanna M Fisher B.S., Lan Huynh B.S., Edgar V. Sales B.S., and Veena M. Singh M.D. Biocept Inc, San Diego CA 2019 SABCS Session: Detecon/Diagnosis - Circulang Tumor Cells Poster# P4-01-13 Background Results Results Results Methods The detecon and molecular characterizaon of circulang tumor cells (CTCs) in paents with breast cancer affords the ability to profile and monitor paents in real me for progression, risk straficaon, recurrence, idenficaon of potenally aconable therapeuc targets, and monitoring of treatment efficacy and emergence of resistance mechanisms. To harness the promise of CTC analysis a highly sensive, robust, reproducible and clinically validated technology is required. Informaon acquired from a single ssue biopsy has temporal and spaal limitaons; addionally, in paents with progressive/metastac disease, a single biopsy may not be informave or in some instances difficult to perform and might fail to reflect inherent tumoral heterogeneity. CTCs on the other hand can provide a contemporaneous landscape of all cancerous lesions (primary and metastases) as well as the opportunity to track the evolving tumor genec mechanisms. Conclusions • The Target Selector™ CTC detecon assay has demonstrated highly specific and sensive CTC capture both for epithelial and non-epithelial sub-sets. • Hence the ability to capture and characterize a broader range of CTCs unlike other CTC technologies that idenfy only epithelial CTCs or ulize sized based selecon would be beneficial for subsequent biomarker analysis and clinical outcomes assessment. Summary • 92% concordance for Clinical Accuracy and 100% for Analycal Specificity was obtained. • Based on the linearity/reportable range data above, one (1) CTC per 8.0 mL can be detected by the Target Selector™ CTC plaorm resulng in a limit of detecon of one (1) CTC in a channel. References 1. Pecot CV, Bischoff FZ, Mayer JA, Wong KL, Pham T, Bosford-Miller J, Stone RL, Lin YG, Jaladurgam P, Roh JW, Goodman BW, Merri WM, Pircher TJ, Mikolajczyk SD, Nick AM, Celesno J, Eng C, Ellis LM, Deavers MT, Sood AK. A novel plaorm for detecon of CK+ and CK- CTCs. Cancer Discov. 2011 Dec;1(7):580-6. 2. Mayer JA, Pham T, Wong KL, Scoggin J, Sales EV, Clarin T, Pircher TJ, Mikolajczyk SD, Coer PD, Bischoff FZ. FISH-based determinaon of HER2 status in circulang tumor cells isolated with the microfluidic CEE™ plaorm. Cancer Genet. 2011 Nov;204(11):589-95. Peripheral blood from 2,757 paents across all stages of breast cancer and treatment me points (pre-treatment, post-treatment, on treatment) were collected in CEE-Sure™ blood collecon tubes and analyzed. CTC capture, staining, and FISH were performed in the microchannel as previously described 1-2 . Briefly, the CEE-Sure™ Microchannels were stained with pan- cytokeran cocktail, CD45, pan-CTC stain, and DAPI. Figure 1. Workflow of the Target Selector™ CTC Plaorm Assays Figure 2. Schemac Illustrang the benefits of the CEE-Sure™ Blood Collecon Tubes Figure 3. Types of cells captured in the microfluidic channels Table 1: Target Selector™ CTC Detecon Assay Overall Performance Summary Figure 4: Biomarker Detecon reported as percentages across all samples and across all stages CEE-Sure™ Blood Collecon Tubes Variety of Cell Types Captured CTC Detecon CTC Detecon Assay Performance Random size and placement of posts FISH for Rearrangements ICC for Proteins Copy Number Variaons Target Selector ™ CTC Detecon Assay Overall Summary of Passing Performance STUDY RESULTS Accuracy 92.0% Precision (%CV) Intra-Assay 19.1% Inter-Assay 17.7% Analycal Specificity 100.0% Clinical Specificity 93.0% Clinical Sensivity 82.0% Limit of Detecon One (1) CTC Reportable Range Detecon of CTCs were linear over the reportable range of 0 to 2094 tumor cells Dynamic Range Dynamic range of 1 to 136674 tumor cells 62.9% 12.3% 0 500 1000 1500 2000 2500 3000 CTC HER2 Total Samples All Stages Stage IV Breast 80.40% 20.50% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 100 200 300 400 500 600 700 800 900 CTC HER2 % Detected CTC and HER2 Detecon Total Cases % Detected
Transcript of Clinical Data in Over 1,500 Patients Across All Stages of ... · (%CV) Intra-Assay 19.1%...
Clinical Data in Over 1,500 Patients Across All Stages of Breast Cancer with Target Selector™ Circulating Tumor Cell Technology
Julie Ann Mayer Ph.D., Deanna M Fisher B.S., Lan Huynh B.S., Edgar V. Sales B.S., and Veena M. Singh M.D.
Biocept Inc, San Diego CA
2019 SABCS
Session: Detection/Diagnosis - Circulating Tumor Cells
Poster# P4-01-13
Background Results Results Results
Methods
The detection and molecular characterization of circulating tumor cells (CTCs) in patients with breast cancer affords the ability to profile and monitor patients in real time for progression, risk stratification, recurrence, identification of potentially actionable therapeutic targets, and monitoring of treatment efficacy and emergence of resistance mechanisms. To harness the promise of CTC analysis a highly sensitive, robust, reproducible and clinically validated technology is required. Information acquired from a single tissue biopsy has temporal and spatial limitations; additionally, in patients with progressive/metastatic disease, a single biopsy may not be informative or in some instances difficult to perform and might fail to reflect inherent tumoral heterogeneity. CTCs on the other hand can provide a contemporaneous landscape of all cancerous lesions (primary and metastases) as well as the opportunity to track the evolving tumor genetic mechanisms.
Conclusions• The Target Selector™ CTC detection assay has demonstrated highly
specific and sensitive CTC capture both for epithelial and non-epithelial sub-sets.
• Hence the ability to capture and characterize a broader range of CTCs unlike other CTC technologies that identify only epithelial CTCs or utilize sized based selection would be beneficial for subsequent biomarker analysis and clinical outcomes assessment.
Summary• 92% concordance for Clinical Accuracy and 100% for Analytical Specificity
was obtained.• Based on the linearity/reportable range data above, one (1) CTC per 8.0
mL can be detected by the Target Selector™ CTC platform resulting in a limit of detection of one (1) CTC in a channel.
References1. Pecot CV, Bischoff FZ, Mayer JA, Wong KL, Pham T, Bottsford-Miller J, Stone RL, Lin YG,
Jaladurgam P, Roh JW, Goodman BW, Merritt WM, Pircher TJ, Mikolajczyk SD, Nick AM, Celestino J, Eng C, Ellis LM, Deavers MT, Sood AK. A novel platform for detection of CK+ and CK- CTCs. Cancer Discov. 2011 Dec;1(7):580-6.
2. Mayer JA, Pham T, Wong KL, Scoggin J, Sales EV, Clarin T, Pircher TJ, Mikolajczyk SD, Cotter PD, Bischoff FZ. FISH-based determination of HER2 status in circulating tumor cells isolated with the microfluidic CEE™ platform. Cancer Genet. 2011 Nov;204(11):589-95.
Peripheral blood from 2,757 patients across all stages of breast cancer and treatment time points (pre-treatment, post-treatment, on treatment) were collected in CEE-Sure™ blood collection tubes and analyzed. CTC capture, staining, and FISH were performed in the microchannel as previously described1-2. Briefly, the CEE-Sure™ Microchannels were stained with pan-cytokeratin cocktail, CD45, pan-CTC stain, and DAPI.
Figure 1. Workflow of the Target Selector™ CTC Platform Assays
Figure 2. Schematic Illustrating the benefits of the CEE-Sure™ Blood Collection Tubes
Figure 3. Types of cells captured in the microfluidic channels
Table 1: Target Selector™ CTC Detection Assay Overall Performance Summary
Figure 4: Biomarker Detection reported as percentages across all samples and across all stages
CEE-Sure™ Blood Collection Tubes Variety of Cell Types Captured CTC Detection
CTC Detection Assay Performance
Random size and placement of posts
FISH for Rearrangements
ICC forProteins
Copy NumberVariations
Target Selector™ CTC Detection Assay Overall Summary of Passing Performance
STUDY RESULTS
Accuracy 92.0%
Precision(%CV)
Intra-Assay 19.1%
Inter-Assay 17.7%
Analytical Specificity 100.0%
Clinical Specificity 93.0%
Clinical Sensitivity 82.0%
Limit of Detection One (1) CTC
Reportable Range Detection of CTCs were linear over the reportable range of 0 to 2094 tumor cells
Dynamic Range Dynamic range of 1 to 136674 tumor cells
62.9%
12.3%
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2000
2500
3000
CTCHER2
Tota
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All Stages Stage IV Breast
80.40%
20.50%
0%10%20%30%40%50%60%70%80%90%100%
0100200300400500600700800900
CTCHER2
% D
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CTC and HER2 Detection
Total Cases % Detected
