OncoCytes initial focus is on a confirmatory diagnostic solution - - PowerPoint PPT Presentation

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oncocyte s initial focus is on a confirmatory diagnostic
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OncoCytes initial focus is on a confirmatory diagnostic solution - - PowerPoint PPT Presentation

Mar 22, 2023 149 likes •206 views

OncoCytes initial focus is on a confirmatory diagnostic solution Confirmatory 7 10M Americans 30 Pack-year history Malignant USPSTF Guidelines recommended screening covered by Medicare Biopsy Benign Nodules nodule High-risk

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SLIDE 1

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High-risk patients LDCT screening Clear Biopsy Malignant Benign nodule Follow-up LDCT scans Nodules

Confirmatory

OncoCyte’s initial focus is on a confirmatory diagnostic solution

No nodules

Additional 5M Americans

30 Pack-year history USPSTF Guidelines recommended screening – covered by Medicare

7–10M Americans

Incidentally detected nodules

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SLIDE 2
  • Prototype classifier presented at 2015

ATS annual meeting

  • Sensitivity: 76%; Specificity: 88%
  • Proof of concept for confirmatory, screening

diagnostic

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  • Bioinformatics lab of
  • Dr. Louise C. Showe
  • 9+ years developing blood-

based tests for lung cancer

  • Significant sample set (3,000

samples and ongoing collection)

  • OncoCyte exclusive global

licensing agreement

OncoCyte’s preliminary test shows strong performance

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SLIDE 3

Wistar validation shows strong results

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  • Validated results of earlier study with

comparable findings

  • Large sample (n=610) analysis,

biomarkers only

  • Sensitivity 90%; Specificity 62%
  • Results suggest commercially attractive

diagnostic

  • OncoCyte internal cross-validation

study underway

  • Results anticipated March 2017
  • Poster discussion session at

May 2017 ATS annual meeting

NEXT STEPS

100 Gene Model

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SLIDE 4

Breast confirmatory diagnostic second product focus due to high unmet need

Follow-up MRI

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Two potential intended use profiles

  • Confirmatory for suspicious

mammograms

  • Adjunct for high-risk patients
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SLIDE 5

Compelling proof of concept presented at 2016 San Antonio Breast Cancer Symposium

Serum Samples SomaScan 1.3K Biomarker Identification

15-Marker Model: AUC = 0.92 Sensitivity = 90%, Specificity = 76%

  • Serum samples from 100 women

with suspicious imaging results

  • Pathology confirmed benign (50) and

malignant (50)

  • Malignancy detected in Stages I and

II at 90% sensitivity, 76% specificity

  • Proof of concept for non-invasive

blood test which could help to avoid unnecessary biopsies

  • OncoCyte is undertaking 300 patient

study to confirm initial results Serum Biomarker Assay Research

Patients undergoing biopsy Screen 1,310 protein analytes in multiplexed format Analysis and algorithm development

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