Notice Number: NOT-CA-19-070

Key Dates
Release Date: August 29, 2019

Issued by
National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to inform potential applicants about a clarification regarding required genomic characterizations for RFA-CA-19-045 " Participant Engagement and Cancer Genome Sequencing (PE-CGS) (U2C Clinical Trial Optional)". Specifically, the change pertains to the required characterizations performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

The correction applies to Section I., Subheading, "Required Attributes of the Genomic Characterizations Proposed for U2C Research Centers", under "Required Characterizations". This text currently reads:

All genomic characterizations must be conducted in parallel on tumor and normal specimens in Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (state-of-the-art methods are expected).

This text is now corrected to read:

All genomic characterizations must be conducted in parallel on tumor and normal specimens. Whole exome sequencing (WES) must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Other genomic characterizations need not be done in a CLIA pipeline. State-of-the-art methods are expected for all genomic characterizations.

In addition, the correction applies to Section I., Subheading, " Structure of the PE-CGS U2C Research Centers", under " Genome Characterization Unit". This bullet currently reads:

• Perform, at a minimum, whole exome sequencing (WES), low-pass whole genome sequencing (coverage of 15X), and RNA sequencing of tumor and normal specimens in a CLIA-certified laboratory using state-of-the-art methods;

This bullet is now corrected to read:

• Perform, at a minimum, whole exome sequencing (WES), low-pass whole genome sequencing (coverage of 15X), and RNA sequencing of tumor and normal specimens using state-of-the-art methods. WES must be performed in a CLIA-certified laboratory;

All other aspects of RFA-CA-19-045 remain unchanged.

Inquiries

Please direct all inquiries to:

Leah E. Mechanic, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6847
Email: NCI_PE-CGS@mail.nih.gov

Elizabeth M. Gillanders, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6764
Email: NCI_PE-CGS@mail.nih.gov

Wen-Ying Sylvia Chou, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6954
Email: NCI_PE-CGS@mail.nih.gov