On February 20, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that the National Comprehensive Cancer Network (NCCN) has updated its medical guidelines for prostate cancer treatment to broadly include biomarker testing in prostate cancer (Press release, Myriad Genetics, FEB 20, 2018, View Source [SID1234524056]). The changes to the guidelines include new language supporting Prolaris as standard of care in treatment decision making for patients with low and favorable-intermediate risk prostate cancer. Additionally, the new guidelines support an expansion of hereditary cancer testing for prostate cancer to include all patients with a family history regardless of Gleason score along with all patients with metastatic disease, and new recommendations supporting testing for homologous recombination deficiency (HRD) in patients with metastatic prostate cancer.

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"We view this significant update in guidelines as a clear indication of the increasing importance of molecular biomarkers in guiding prostate cancer care and Myriad is uniquely positioned with its broad portfolio of tests to address these clinical needs," said Nicole Lambert, general manager, Urology. "These new guidelines are critical in our efforts to broaden insurance coverage and increase patient access to Myriad’s entire portfolio of prostate cancer molecular diagnostic tests."

Below are the key updates from the guidelines:

Prolaris: now standard of care for 110,000 patients per year identified as low or favorable-intermediate risk patients.
myRisk Hereditary Cancer: now recommended for approximately 70,000 prostate cancer patients per year including all patients with metastatic prostate cancer and those with a family history of cancer regardless of Gleason score.
myChoice HRD: now recommended for 20,000 patients per year with metastatic prostate cancer to identify tumors with homologous recombination deficiency (HRD) so that these patients can be considered for targeted therapies.
About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with the development of eight hereditary cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification, a medical management tool and exceptional customer service.

Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and therefore eligible for myRisk Hereditary Cancer test.

About myChoice HRD
Myriad’s myChoice HRD is the most comprehensive homologous recombination deficiency test, enabling physicians to identify tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).

Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. Learn more: View Source