Myriad Genetics ($MYGN) faces the risk of its rheumatoid arthritis (RA) test Vectra DA may be excluded from coverage under Medicare program. The company told Streetinsider that it is disappointed that the MolDx program published a draft non-coverage decision for the test. Myriad stated that it strongly disagrees with the conclusions.
The decision has been based on data from the recently published AMPLE study. The company said that the study had severe shortcomings and limitations. It further stated that over 20 studies covering more than 3,000 patients have demonstrated the efficacy of the test.
The decision is not final yet. Myriad stock had a rough year as it lost over 60% of its value this year. The company suffered net loss in its first quarter. It announced loss of $1.2 million or $0.02 per share for the quarter ended September 30. It had reported $30.3 million in profit for the corresponding quarter of the previous year.
However, the company has otherwise strong pipeline, which may boost up its stock price. Myriad recently announced results of a large head-to-head study comparing the efficacy of six tests used to predict the recurrence of breast cancer. The study revealed that EndoPredict® (EPclin), a second-generation test, was superior to Oncotype Dx™ (RS), a first-generation test, in predicting the long-term recurrence of breast cancer.