National Study to Follow Patient Outcomes After BRCA1 Genetic Testing

October 1, 1996

SALT LAKE CITY--Myriad Genetic Laboratories, Inc. and the American College of Surgeons (ACS) have announced a long-term study that will follow the outcomes of patients currently undergoing BRCA1 genetic analysis for breast and ovarian cancer susceptibility.

SALT LAKE CITY--Myriad Genetic Laboratories, Inc. and the AmericanCollege of Surgeons (ACS) have announced a long-term study thatwill follow the outcomes of patients currently undergoing BRCA1genetic analysis for breast and ovarian cancer susceptibility.

The study--ACS-Myriad BRCA1 Longitudinal study (AMBLS)--will addresstwo major questions: Which BRCA1 mutations are strongly penetrant(have a strong correlation to the risk of getting the disease),and what is the likely clinical outcome after medical and surgicalintervention.

Sloan-Kettering to Administer

Administered for the ACS by the Sloan-Kettering Institute forCancer Research (SKI) in New York, the study will be under thecoordination of Ken Offit, MD, MPH, chief, Clinical Genetic Service,Department of Human Genetics, and Pat Borgan, MD, chief, BreastService, Department of Surgery, at SKI, and Dr. Samuel Wells,vice chair of the ACS board.

The AMBLS study will utilize Myriad's BRACone genetic analysistest and multicenter patient database to obtain mutation incidenceand clinical data. Investigators will fill out a baseline registrationform for consenting patients. At the patient's annual exam, investigatorswill provide follow-up information concerning the patient's status.

To ensure confidentiality, codes linking the database to patientidentifiers will reside solely in the hands of the patient's localphysician investigator.