Pipeline

Lung Cancer Risk Predictor

bcr/abl

Pipeline





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PIPELINE

Test

# of Genes

Sample Types

# of Samples

Clinical Accuracy

Correlation Coefficient

Next Step

LungSentryDx-Genetic Predisposition to Lung Cancer Risk

10

Normal BEC from Non-CA Patients

27 

96% Sensitivity 78%  Specificity

NA

Pre-IDE FDA Meeting; Proceed with Clinical Validation

Normal BEC from CA Patients

22

Lung Cancer Diagnostic

3

Lung cancer FNA

80

>87% Sensitivity

>96% Specificity

NA

Test Additional Samples (use with RNA Quality test)

Primary Normal

58

SCLC vs NSCLC Subclassification Diagnostic

2

SCLC FNA Biopsy

5

75% Sensitivity 96% Specificity

NA

Validate 50-100 more samples

NSCLC FNA Biopsy

55

Irinotecan (CPT-11) Chemoresistance

4

Carcinoma Cell Lines

15

100% Sensitivity 95% Specificity

>0.9

Test a Cut-Off in Clinical Samples

Cisplatin Chemoresistance

4

Carcinoma Cell Lines

14

NA

>0.9

Test a Cut-off in Clinical Samples

 

Test

# of Genes

Sample Types

# of Samples

Clinical Accuracy

Correlation Coefficient

Next Step

BCR-ABL1 – Monitoring therapy for chronic myelogenous leukemia

4

Whole blood / CML cell lines

TBA

TBA

TBA

Test a Cut-off in Clinical Samples

JAK – Myeloid Neoplasia

TBA

Whole blood / Myeloid Neoplasia  cell lines

TBA

TBA

TBA

Test a Cut-off in Clinical Samples

Male Infertility diagnostic-sperm metabolic dysfunction

14

Normal-healthy volunteers

30 

TBA

TBA

Sample collection

Samples from smokers and patients with infertility of unknown etiology

30

Male Infertility diagnostic-Presence of leukocytes in ejaculate

3

Patients testing positive for leukocytes using current methodology and normal

12

100

TBA

Sample collection

 

 
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