LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Percepta© Bronchial Genomic Classifier (DL37195).

A55646

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Article ID
A55646
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Article Title
Response to Comments: MolDX: Percepta© Bronchial Genomic Classifier (DL37195).
Article Type
Response to Comments
Original Effective Date
09/16/2017
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) MolDX-CDD: Percepta© Bronchial Genomic Classifier (DL37195). Thank you for the comments.

Response To Comments

Number Comment Response
1

In the description for the Draft LCD, it indicates that the contractor is aware that Veracyte, Inc., is running a registry trial for a prospective evaluation. With low specificity and low positive predictive value, why initiate limited coverage now, he asked, instead of waiting until after the trial is completed?

Screening of smokers for lung cancer has resulted in a marked increase of patients with solitary lung nodules.  Clinical characteristics such as older age, smoking history, nodule size and speculation correlate with a higher risk of malignancy.  Anatomic location, solid versus part-solid or non-solid characteristics, and time since smoking discontinuation have had less consistent correlation.  A non-diagnostic bronchoscopy (40% of all procedures) leaves the treating physician with a dilemma.  Many patients assigned with a physician-assessed low or intermediate risk of malignancy frequently undergo costly serial CT surveillance, invasive biopsies, and surgery for benign disease.  A negative result in a test with high sensitivity is useful for ruling out disease.  A high sensitivity test is reliable when its result is negative, since it rarely misdiagnoses those who have the disease.   A test with 100% sensitivity will recognize all patients with the disease by testing positive.  A negative result would definitively rule out presence of the disease in a patient.  A high negative predictive value represents the probability that a negative test identifies a patient who does NOT have disease.  It is Precepta’s high sensitivity and high negative predictive value that show promise as a molecular lung cancer biomarker. 

Description Results
(with 95% Confidence Intervals if applicable)*
Low pretest risk (n = 62) Intermediate pretest risk (n = 101)
Sensitivity 100% (16-100%) 88% (68-97%)
Specificity 56% (42-69%) 48% (35-62%)
Negative Predictive Value (NPV) 100% (89-100%) 91% (75-98%)
Positive Predictive Value (PPV) 7% (1-24%) 40% (27-55%)
Cancer prevalence 5% 41%
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37195 - MolDX: Percepta® Bronchial Genomic Classifier
Related National Coverage Documents
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