On May 8, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal third-quarter 2018, provided an update on recent business highlights and raised its fiscal year 2018 financial guidance (Press release, Myriad Genetics, MAY 8, 2018, View Source [SID1234526272]).

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"We saw strong results in the third quarter with financial performance once again exceeding our expectations due to better than anticipated hereditary cancer volumes, strong new product volume growth and the success of our Elevate 2020 program," said Mark C. Capone, president and CEO, Myriad Genetics. "Our diversification efforts achieved record results in the third quarter, with new products now representing 71 percent of sample volume and 36 percent of revenue. And the landmark GeneSight clinical trial results have led to our first commercial coverage decision. Given that this new product growth is being built upon a solid hereditary cancer foundation, we are raising our financial guidance for fiscal year 2018."

Business Highlights

Hereditary Cancer

Achieved the fifth consecutive quarter of year-over-year hereditary cancer volume growth with total hereditary cancer volume exceeding our three percent growth target on a year-over-year basis.

riskScore led to accelerating growth in our preventive care segment over the last two quarters.

GeneSight

Revenue increased 27 percent year-over-year to $30.4 million with record volumes in the quarter.

Myriad has been notified of a commercial coverage decision from a top-20, mid-Atlantic payer.

Presented data from the largest-ever pharmacogenomics clinical study in patients with moderate-to-very severe depression at the American Psychiatric Association annual meeting in New York City, demonstrating that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight Psychotropic genetic test.

Submitted the randomized controlled trial study manuscript to a peer-reviewed journal and anticipate publication around the end of fiscal year 2018.

Submitted manuscripts for the IMPACT study and a second major health economic study utilizing the

Optum Healthcare Solutions dataset.

Vectra DA

Revenue increased 34 percent year-over-year in the quarter with volumes growing in the double-digits on a sequential basis.

Initiated plans to move the Vectra DA customer service group and commercial laboratory to our Salt Lake City headquarters with plans to complete both moves by the end of fiscal year 2019.

Prolaris

Revenue in the quarter increased 91 percent year-over-year to $6.5 million and test volumes grew 10 percent sequentially.

NCCN issued new guidelines supporting Prolaris as standard of care for treatment decisions in patients with low and favorable-intermediate risk prostate cancer. The guidelines also support the broad use of hereditary cancer testing in 40,000 specific prostate cancer patients diagnosed every year in the United States and support the use of biomarkers such as myChoice HRD Plus to identify prostate cancer patients for targeted therapies.

American Association of Clinical Urology and the Large Urology Group Practice Association, that represent 70 percent of urologists in the country, issued a position paper supporting the new NCCN guidelines.

Received positive medical policy recommendations for Prolaris in the quarter from 14 Medicaid states, first Blue Cross Blue Shield plan and several regional payers.

EndoPredict

Reported $2.3 million in the quarter an increase of 15 percent sequentially.

Received final Medicare local coverage decision from Noridian which became effective on January 30 increasing total coverage to approximately 90 percent of the United States market.

One of the largest private insurers in the United States has expanded its coverage policy on EndoPredict to aid in the clinical decision of whether or not to extend adjuvant hormonal therapy beyond five years of treatment.

Companion Diagnostics

Received Food and Drug Administration approval for BRACAnalysis CDx as a companion diagnostic in conjunction with AstraZeneca’s Lynparza (olaparib) for HER2- metastatic breast cancer.

Launched BRACAnalysis CDx to approximately 3,000 oncologists who treat greater than two-thirds of metastatic breast cancer and saw a 70 percent increase in metastatic breast cancer testing in the third quarter compared to the second quarter.

International

Received a revised draft guidance document from the United Kingdom’s National Institute for Health and Care Excellence (NICE) which includes EndoPredict as one of three approved breast cancer prognostic tests.

Initiated a restructuring to shift all laboratory developed testing to United States laboratories which will lead to closing the laboratory in Munich Germany and the sale of the German Clinic.

Received pre-market approval from the Japanese Ministry of Health, Labor, and Welfare for our BRACAnalysis CDx test for HER2- metastatic breast cancer.

Conference Call and Webcast

A conference call will be held today, Tuesday, May 8, 2018, at 7:30 a.m. EST to discuss Myriad’s financial results for the fiscal third-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-699-0623. International callers may dial 1-303-223-4362. All callers will be asked to reference reservation number 21887258. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.