LCD Reference Article Response To Comments Article

Response to Comments: MolDX-CDD: Percepta©

A55453

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A55453
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Article Title
Response to Comments: MolDX-CDD: Percepta©
Article Type
Response to Comments
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03/13/2017
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The comment period for the MolDX: APC and MUTYH Gene Testing (LCD) DL36908 began on 11/16/2016 and ended on 01/03/2017. Comments were received from
the provider community. The notice period begins on 01/26/2017 and ends 03/12/2017 . The LCD becomes final on 03/13/2017.

Response To Comments

Number Comment Response
1 Veracyte is currently sponsoring the PERCEPTA Registry Trial, an IRB approved, prospective observational trial involving 43 academic and community hospital sites across the United States. In the Registry, the Percepta classifier is being utilized prospectively in the management of eligible patients at low or intermediate pre-test risk who have an inconclusive bronchoscopy result. The PERCEPTA Registry is collecting an extensive body of clinical, imaging and outcome data of the ‘real world’ utilization of the test. The data elements being collected include but are not limited to: age, smoking history, physician assessed risk of malignancy, CT scan images, CT scan reports, cytology reports from the index bronchoscopy, lesion size, characteristics, location, presence of adenopathy, Percepta classifier results, pre-Percepta diagnostic plan, post-Percepta diagnostic plan, histopathology reports for patients who proceed to surgery or other invasive diagnostic procedures and longitudinal follow-up data. Patients consented and enrolled in the PERCEPTA Registry Trial will be followed for up to three years post index bronchoscopy when their Percepta classifier sample is collected. The objectives of the PERCEPT Registry are to prospectively evaluate the adoption, utilization, test performance, safety and outcome of patients managed prospectively using the Percepta classifier. Study investigators have already presented interim analysis data from the Percepta Registry at the annual meeting of the American College of Chest Physicians in Los Angeles, CA., and they intend to publish on clinical outcomes of patients managed with the Percepta classifier to further inform clinical practice protocols. The intended use population for the Percepta classifier is not the same as the population who undergoes lung cancer screening. Patients indicated for the Percepta classifier are only those patients with an inconclusive bronchoscopy result. Therefore, we do not recommend that the comparator of performance for Percepta be the current screening standard. However, we would recommend that among those patients with post-Percepta test risk result of ‘very low’ or ‘low’ risk, that they demonstrate clinical stability during a 12 month clinical follow-up period using either standard RECIST criteria (v1.1) on CT imaging of the index lesion or other standard-of-care clinical criteria consistent with a benign diagnosis and commensurate with the performance characteristics of the Percepta classifier as published in the New England Journal of Medicine(NEJM). This Medicare contractor welcomes the prospective data that will be derived from the PERCEPT Registry to support evidence of clinical utility that will further define and support continued coverage.
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