Purpose

This policy describes the scope of services provided by the Salt Lake City site of Myriad Genetics Inc. and specifically includes hours of operation, test menu, and turnaround times for each of the clinical tests offered. It also describes the policy for notifying physicians when testing is delayed.

Scope

This policy applies to the Salt Lake City site of Myriad Genetics Inc.

Definitions

Term	Definition
Turnaround Time (TAT)	The interval between specimen release by Customer Service and results reporting.

Provisions

Hours of Operation

Myriad accepts patient samples via FedEx every day.

Myriad is not open to the public. Patients will need to contact their healthcare providers (HCPs).

Test Menu

Myriad Genetic Laboratories, Inc. (MGL) is a free-standing laboratory and subsidiary of Myriad Genetics, Inc. (MGI). The first MGL product was launched in 1996.

MGL’s predictive and personalized test offerings include:

BRACAnalysis® – assesses a person’s risk of developing hereditary breast or ovarian cancer based on the detection of mutations in the BRCA1 and BRCA2 genes (November 27, 1996)

Colaris® - assesses a person’s risk of developing hereditary colorectal cancer and a woman’s risk of developing hereditary uterine/endometrial cancer by detecting disease-causing mutations in the MLH1, MSH2, MSH6 and PMS2 genes (December 21, 2000)

Colaris AP® - testing assesses a person’s risk of developing hereditary colorectal polyps and cancer by detecting mutations in the APC and MYH genes
(June 14, 2002)

EndoPredict - a molecular diagnostic test that analyzes 12 genes in early stage breast cancer. EndoPredict can be used in conjunction, with other clinical parameters, to aid in clinical management by determining the risk of distant recurrence for the patient over a 10-year timeframe. (March 10, 2017)

Melaris® – assesses a person’s risk of developing hereditary melanoma by detecting inherited mutations in the p16 gene (also called CDKN2A or INK4A) (May 9, 2002)

Panexia™ – assesses a person’s risk of developing hereditary pancreatic cancer by analyzing the PALB2 and BRCA2 genes, which are most commonly mutated in families with hereditary pancreatic cancer (November 10, 2010)

Prolaris® - a molecular diagnostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris® can be used in conjunction with other clinical parameters to determine prostate cancer aggressiveness (February 12, 2012)

MyRisk™ Hereditary Cancer (including myRisk™ Disease Specific Panels (DSPs)) – a multi-gene panel that helps to determine a patient’s risk by evaluating a number of hereditary cancer syndromes, with focus on primary cancer sites (September 3, 2013)

BRACAnalysis CDx™ - an FDA-approved companion diagnostic test for germline BRCA1 and BRCA2 mutations intended to be used as an aid in treatment decision making (December 19, 2014)

MyChoice™ CDx - a next generation sequencing (NGS) test designed to identify a comprehensive signature for Homologous Recombination Deficiency (HRD) by testing genome-wide single nucleotide variants in DNA extracted from FFPE tumor specimens (February 24, 2016)

Precise Tumor™ - a comprehensive germline testing and somatic tumor profiling test that is comprised of Myriad Assays (available assays: MyRisk™ Hereditary Cancer, BRACAnalysis CDx™, BRACAnalysis®, MyChoice™ CDx) (March 14, 2022)

Turnaround times are defined as follows:

Assay	TAT (days)
BRACAnalysis	14
Colaris	21
Colaris AP	21
EndoPredict	14
Melaris	14
Panexia	14
Prolaris	14
MyRisk Hereditary Cancer	21
BRACAnalysis CDx	14
MyChoice CDx	14
Precise Tumor	14

The ordering healthcare provider (HCP) will be notified of delayed testing by the Customer Service department one day after the TAT has been exceeded. For example, HCP will be notified on day 22 of delayed Colaris testing.

Sources

Title
College of American Pathologists (CAP) Lab General Checklist 2021

Referenced Documents

Document Number	Title
None	None

Additional Resources

Document Number	Title
SOP-0527	Nonconformance (NC) and CAPA Procedure
SOP-1216	Customer Service Case Processing-Patient Services Coordinators

Revision History

Change Control # (if applicable)	Revision Number	Author(s)	Affected Sections	Description of Changes
CC-2022-153	06	Amanda Arnesen	All	Updated title to include Scope of Service and Test Menu. Added operating hours and test menu.
Additional Resources	Updated title of SOP-0527.
N/A	05	Alexis Jones, Jennifer Dansie	Provisions	Removed SARS-CoV-2, Vectra, and myPath Melanoma; added Precise Tumor
Michelle Sharkey	All	Updated template and document numbers due to MasterControl upgrade.
CCG_2021_2736	MGL POL 027.4	Jamie Bodily	Provisions	Added SARS-CoV-2, updated myChoice CDx name.

Appendices

None