Myriad Launches Proprietary AMPLIFY Technology, Further Increasing the Performance of its Prequel NIPS Test

SALT LAKE CITY, July 29, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched its proprietary AMPLIFY technology, which further increases the performance of its Prequel noninvasive prenatal screening (NIPS) test. The proprietary AMPLIFY process increases the fetal fraction of a NIPS sample by preferentially sequencing the fetal cell-free DNA fragments that circulate in a mother’s blood. AMPLIFY technology enables more accurate detection of fetal chromosome abnormalities. In the analytical validation involving samples from more than 1,000 pregnant women, fetal fraction is 2.3 times greater on average with AMPLIFY than with standard NIPS. This improvement reduces false positive and false negative results—including for common aneuploidies, expanded aneuploidies, microdeletions and a baby’s sex. For instance, false negative performance in common aneuploidies improves 45x with AMPLIFY technology. Additionally, no samples powered by AMPLIFY technology had a fetal fraction below four percent. Other laboratories may fail samples with less than four percent fetal fraction. 

“Prequel already provided highly accurate results and this proprietary technology further increases the sensitivity of our test,” said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. “With AMPLIFY, Prequel maintains an industry-leading low rate of failed samples—delivering results to 99.9 percent of patients. The important clinical benefits are that each woman who receives the test can expect highly accurate NIPS results, regardless of body mass index (BMI), race, or ethnicity.”

Up to 50 percent of pregnant women present with high BMI to their healthcare provider. Studies have demonstrated that BMI is not evenly distributed across ethnicities, and up to 24 percent of women with high BMI will not receive a result on standard NIPS platforms due to low fetal fraction. Women who don’t receive a result may do no further prenatal screening at all; they may go through subsequent rounds of NIPS, or they may undergo invasive procedures such as an amniocentesis or chorionic villus sampling, which can increase the risk of miscarriage and add unnecessary expense to the US healthcare system. Prequel with AMPLIFY technology overcomes the limitations of standard NIPS in order to provide equity of care to pregnant women.