TOO MUCH IS AT STAKE.

Purpose of the petition

Hereditary cancer genetic screening is essential to patient care and utilized in numerous clinical settings. According to the National Cancer Institute, inherited cancer causing genetic variants are thought to contribute to approximately 5 to 10% of all cancers. However, hereditary cancer genetic tests from different clinical laboratories vary in accuracy and usefulness in non-transparent ways. These differences are due in part to weak regulation of laboratory developed testing in the United States. Lack of transparency and a low bar for laboratory credentialing make it difficult for clinicians and patients to confidently select the most appropriate tests, even when hereditary cancer testing is recommended by clinical guidelines. To address this information gap, the Utah Department of Health and Human Services Cancer Genomics Program has contracted with the Center for Genomic Interpretation, in collaboration with the Association for Utah Genetic Counselors, to perform a survey of prominent laboratories offering comprehensive hereditary cancer testing to patients nationwide. In addition to petition signers on this webpage, the survey has been foundationally endorsed by the Screening and Genetics Section within the Division of Prevention and Community Health of the Washington State Department of Health, and the ScreenWise Program of the Oregon Health Authority, Public Health Division.

The attached transparency survey will facilitate comparison of similarities and differences between major laboratories’ comprehensive hereditary cancer genetic tests, and the laboratories’ patient support services for these tests. The information collected through this survey will be publicly accessible on the TestWisely.org website. Every patient being screened for hereditary cancer, and their clinicians and caregivers should have access to this important information.

Transparency survey sent to laboratories

List of laboratories that received the survey

In the first week of June 2023, the Chief Executive Officers of prominent hereditary cancer testing laboratories received an invitation, via recorded delivery courier service, to voluntarily participate in this transparency effort by having their laboratory complete the transparency survey by the 7th of July, 2023.  In response to laboratory requests, the deadline has been extended to Friday, July 21st for all invited laboratories. The following eleven executives received invitations regarding their tests:

Mr. Tom Schoenherr, CEO of Ambry Genetics, for their CustomNext-Cancer test.

Mr. Andy Theurer, CEO of ARUP Laboratories for their Hereditary Cancer Panel.

Mr. Othman Laraki, CEO of Color Health, for their Color Hereditary Cancer Test.

Kevin T. Conroy, Esq., CEO of Exact Sciences, for their PreventionGenetics Cancer Panel.

Mr. Ming Hsieh, CEO of Fulgent Genetics, for their Full Comprehensive Cancer Panel.

Ms. Katherine Stueland, CEO of GeneDx, for their Comprehensive Common Cancer Panel.

Mr. Kenneth Knight, CEO of Invitae, for their Invitae Multi-Cancer Panel.

Mr. Adam H. Schechter, CEO of Labcorp, for their VistaSeq Hereditary Cancer Panel.

Paul J. Diaz, Esq., CEO of Myriad Genetics, for their MyRisk test.

Mr. Steve Chapman, CEO of Natera, for their Empower Hereditary Cancer Test.

Mr. James E. Davis, CEO of Quest Diagnostics, for their Comprehensive Hereditary Cancer Panel.

Which laboratories are participating?

Follow the TestWisely.org news feed throughout June 2023 and into the first week of July 2023 for regular updates on which laboratories have accepted the invitation to participate in the transparency survey. Laboratories may choose to participate in full, or in part, or not at all. These updates will also track which laboratories, if any, choose not to participate in this transparency effort. Progress report updates will also be provided on the TestWisely.org news feed regarding the timeline and release dates of the collated information collected from laboratories.

Sources of project funding

Sign the petition

By adding my name and/or my organization’s name below, I endorse the laboratory transparency survey. I urge the invited laboratories to respond on time and in full to all of the survey questions. Transparency from laboratories is essential to improve access to high quality hereditary cancer genetic testing for those that need it.

SIGNING INSTRUCTIONS: Please complete four boxes below.  Also, under “Organization”, you are invited to enter “self” if you are signing on behalf of yourself only and not an organization.