All next generation sequencing (NGS)-derived molecular test results of cancer specimens used in the diagnosis, clinical evaluation or treatment of cancer patients must be reported to the Kentucky Cancer Registry (KCR) and in a format prescribed by KCR in accordance with KRS 214.556.  Tests include, but are not limited to, targeted panels, RNAseq, whole genome sequencing (WGS), whole exome sequencing (WES), and DNA Methylation.  Reportable data currently include, but are not limited to FASTQ, binary sequence alignment maps (BAM), structured RNAseq and the accompanying clinical mutation results (MAF, VCF and/or clinical mutation reports).  Mutation results should include all variants of both known and unknown significance.  PDF clinical reports alone are not sufficient.

Identifiers needed for record linkage

Associated patient identifiers such as name, birth date, social security numbers, medical record numbers, pathology specimen number and other identifiers must accompany test result files.  Identifiers must be sufficient to identify the patient, cancer case and pathology specimen used for sequencing.

Reporting methods and formats

In accordance with KRS 214.556, all healthcare providers are required to report these data to the KCR.  However, it is preferable for molecular testing laboratories report the results directly to the Kentucky Cancer Registry electronically on behalf of the providers.

National standard formats for reporting these data to cancer registries have not yet been established.  KCR is working with NGS labs and national and federal agencies to facilitate the development of such standards. For new providers, KCR will facilitate the establishment of a secure and mutually agreeable transmission mechanism and file format.  Please contact KCR for more information.  

Supported Molecular Data Providers

KCR has an established reporting protocol in place with the following providers:

This information is current as of May 2022.