f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PAS Clinical Study

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Study Status Completed
Application Number /
Requirement Number
P160045 S027/ PAS001
Date Original Protocol Accepted 01/21/2022
Date Current Protocol Accepted  
Study Name PAS Clinical Study
Device Name Oncomine™ Dx Target Test
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of the clinical validation study is to provide evidence in support of the safety and effectiveness of the ODxT Test when used in accordance with its indications for use and product labeling. The study will support the use of the ODxT Test as an aid to determine EGFR exon 20- insertion mutation status in identifying patients with NSCLC screened and enrolled for treatment with JNJ-372 using multiple Clinical Trial Assays (CTAs) in study JNJ-61186372.

The purpose of this PAS is to:
1) Supplement the Olympic clinical study with minimum of approximately 24 additional samples to assess the analytical accuracy of the ODxT Test by evaluating its agreement with an orthogonal test method(s) using EGFR exon 20 insertion-positive clinical samples obtained from the dose expansion cohort of Janssen’s Phase 1/2 clinical trial (Clinical Study Protocol JNJ-61186372);

2) To assess the clinical effectiveness of the ODxT Test in selecting patients for treatment with JNJ-372 administered in subjects with locally advanced or metastatic NSCLC, by evaluating:
a. the concordance between the CTA results and the ODxT Test results
b. the objective response rate (ORR) based on ODxT Test results;
A minimum of approximately 24 EGFR exon 20 insertion mutation-positive NSCLC clinical trial samples collected from the dose expansion Cohort D of Janssen’s clinical study will be tested by both the ODxT Test (CDx) and the TST170 Assay (comparator).
Study Population The primary analyses population includes specimens with valid ODxT Test results from the efficacy evaluable registrational cohort of Janssen’s clinical study.
Sample Size A minimum of approximately 24 EGFR exon 20 insertion mutation-positive NSCLC clinical trial samples collected from the dose expansion Cohort D of Janssen’s clinical study will be tested by both the ODxT Test and the TST170 Assay.
Key Study Endpoints The primary endpoint will be overall response rate (ORR) by RECIST 1.1 as assessed by independent radiologic review and a description of the duration of response (DoR).
Follow-up Visits and Length of Follow-up The efficacy evaluable analysis set will consist of subjects who received at least one dose of study drug and either had at least 2 post-baseline efficacy disease assessments, or discontinued treatment for any reason, or had disease progression/ death prior to the 2nd post-baseline disease assessment. Moreover, subjects in the efficacy evaluable analysis set for this diagnostic study include only those treated at the recommend phase 2 dose (RP2D) with metastatic NSCLC (metastases within 12 months from last platinum-based chemotherapy use) positive for Exon 20 Insertion whose disease progressed on or after platinum-based chemotherapy. This analysis set will be used for efficacy analysis unless otherwise stated.
Interim or Final Data Summary
Actual Number of Patients Enrolled 24
Actual Number of Sites Enrolled 14
Patient Follow-up Rate At least 2 post-baseline efficacy disease assessments
Final Safety Findings The testing for this clinical validation study was conducted retrospectively on archived study specimens. No treatment decisions were made based on any of these test results; therefore, there were no unanticipated adverse device events related to the study products or procedures to subjects or operators.
Final Effect Findings The Blinded Independent Central Review (BICR)-assessed confirmed overall response rate (confirmed Complete Response + confirmed Partial Response) was 41.7% in the primary efficacy population with EGFR exon 20 insertions detected by the ODxT Test (n=24) versus 41.5% in the primary efficacy population (n-41) based on the Clinical Trial Assays (Local tests).
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes Yes. The labeling supplement should include a summary of the post-approval study design and results.

PAS Clinical Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
final report 06/01/2022 05/09/2022 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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