Myriad Genetics Rides On Solid Molecular Diagnostics Suite

Myriad Genetics, Inc. (NASDAQ:MYGN) has been consistently trying expand in the high-potential molecular diagnostics market, which is expected to reach a value of around $10.12 billion at a CAGR of 9.1% between 2016 and 2021 (per a report by MarketsandMarkets).

Progress in Molecular Diagnostics So Far

Of late, Myriad Genetics’ performance in the Molecular Diagnostics business has been encouraging. The company has been gaining on the back of solid contributions from the GeneSight and EndoPredict tests. Management particularly expects double-digit volume growth in fiscal 2018 for GeneSight, Vectra DA, Prolaris and EndoPredict tests, all of which make up a major part of the Molecular Diagnostics portfolio.

GeneSight

Per the company, the GeneSight test represents significant opportunities. As GeneSight is placed in a highly under-penetrated preventive care market, the product has huge growth potential. Management expects consistent growth in GeneSight test revenues in the quarters ahead.

EndoPredict

According to Myriad Genetics, EndoPredict presents a global market opportunity of more than $600 million annually, with major demand in countries like Canada and the United States.

Over the last few months, the company has been making encouraging progress with the EndoPredict test. In March, Myriad Genetics launched the EndoPredict test in the United States for patients with early-stage breast cancer. In August, the company received positive coverage decision for the test from Palmetto GBA, a Medicare Administrative Contractor (MAC) and Anthem, Inc., one of the largest private insurers in the United States. Notably, full implementation of this decision will lend Myriad Genetics coverage for approximately 90% of breast cancer patients.

The company recently announced positive results from a clinical study evaluating EndoPredict which highlights its superiority over the first-generation Oncotype DX Breast Recurrence Score in predicting breast cancer recurrence in women determined to be at intermediate clinical risk by the Nottingham Prognostic Index.

Notably, Myriad Genetics has been riding high on strength in the Hereditary Cancer testing space. In the last reported quarter, the company witnessed year-over-year growth in Hereditary Cancer testing volumes for the third consecutive quarter, with pricing meeting expectations.

myRisk Hereditary Cancer

The company believes the global market for myRisk Hereditary Cancer along with other types of hereditary cancer tests is worth roughly $5 billion annually. In December, Myriad Genetics presented favorable riskScore test data at the 2017 San Antonio Breast Cancer Symposium (SABCS) in Texas. In September, the company introduced riskScore under its myRisk Hereditary Cancer testing portfolio and also presented encouraging riskScore test data. It also announced favorable study results for its myRisk Hereditary Cancer suite.

BRACAnalysis CDx

The company’s companion diagnostic program recently received a boost through the collaboration with AstraZeneca. In October 2017, the company announced FDA acceptance of supplementary premarket approval (sPMA) application for BRACAnalysis CDx’s usage as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer. The company expects the FDA’s priority review process to be completed by third-quarter fiscal 2018. Per management, on approval, the test will be available for around 125,000 metastatic breast cancer patients.

Also, Myriad Genetics submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for treating HER2- metastatic breast cancer patients. Per the company, this approval will help cash in on a market opportunity of more than 10,000 patients per year.

Prolaris

Management seems to be upbeat about the prospects of the Prolaris test as it represents a global market opportunity of approximately $1.5 billion annually.

In May, Myriad Genetics announced the receipt of a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the Prolaris test from Palmetto GBA, a Medicare Administrative Contractor (MAC).

In the same month, the company announced plans of presenting data demonstrating the utility of the Prolaris test in efficiently predicting the 10-year risk of metastases in men treated for prostate cancer at the American Urological Association (AUA) 2017 Annual Meeting. These positive flows of news are expected to to boost the top line in the to-be-reported quarter.

Price Performance

Myriad Genetics has been gaining investor confidence on consistently positive results. Over the past six months, the company’s share price has outperformed the broader industry. The stock has gained 41.1%, compared with the broader industry’s 0.1% rise.

Zacks Rank & Other Key Picks

Myriad Genetics sports a Zacks Rank #1 (Strong Buy).

Other top-ranked medical stocks are PetMed Express, Inc. (NASDAQ:PETS) , Align Technology, Inc. (NASDAQ:ALGN) and Luminex Corporation (NASDAQ:LMNX) . Notably, PetMed and Align Technology sport a Zacks Rank #1, while Luminex carries Zacks Rank #2 (Buy) . You can see the complete list of today’s Zacks #1 Rank stocks here.

PetMed has a long-term expected earnings growth rate of 10%. The stock has rallied roughly 94.1% over a year.

Align Technology has a long-term expected earnings growth rate of 28.9%. The stock has gained 136.1% in a year.

Luminex has a long-term expected earnings growth rate of 16.3%. The stock has gained 4% over the past three months.

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