It’s certainly been a white-knuckle ride in 2019 for shareholders of the molecular diagnostics and precision medicines company Myriad Genetics (NASDAQ: MYGN), with shares doubling and getting halved over a few weeks this summer. A slow climb starting in June from $22 culminated with a 55% explosion on August 1-2 to $48 thanks to news that UnitedHealthcare (NYSE: UNH) was starting to cover a MYGN genetics test. The exuberance didn’t last long, as shares collapsed on August 13 back to where they started upon lower-than-expected revenue and scrutiny from the FDA on claims for marketed genetics tests.
The announcement regarding the FDA and subsequent nosedive in share price spurred an onslaught of lawsuit-trolling legal firms searching for a lead plaintiff is a class action case charging that the company damaged shareholders.
Shares managed to recover from $22 in August back up to $35 at the start of November before once again having the bottom fall out back down to about $20.
On Wednesday, the Salt Lake City-based company offered a little bit of sunshine, saying that a new, large study (>58,000 women) of its Non-Invasive Prenatal Screening (NIPS) product branded Prequel ™ Prenatal Screen was published online in the journal Prenatal Diagnosis. Prequel uses whole genome sequencing to find chromosomal abnormalities during pregnancy, which can indicate diseases such as Down syndrome.
Of particular importance, the research concluded that Prequel is superior to traditional non-DNA screening for identifying chromosomal abnormalities in pregnant women, including those with high body mass index.
Previously, Myriad showed that Prequel is accurate at all fetal fraction levels and doesn’t require a fetal fraction cutoff like other NIPS products. Non-invasive prenatal testing usually requires a minimum fetal fraction for accurate trisomy screening, generally estimated at 4%.
The latest study also suggested that tests that need a fetal fraction cutoff may underperform at higher BMIs versus non-DNA screens.
“In our study, we demonstrated that the Prequel Prenatal Screen delivers accurate results to women irrespective of their body size, race or ethnicity and significantly outperforms NIPS offerings using a 4% fetal fraction cutoff and traditional non-DNA screening methods,” commented Dr. James Goldberg, CMO of Myriad Women’s Health, in a statement on the publication.
Dr. Goldberg went on to explain that Prequel maintaining high analytical sensitivity across the full spectrum of BMI’s means that “more women will receive an answer the first time they are screened, which may reduce patient anxiety and prevent the need for costly invasive procedures like amniocentesis or chorionic villus sampling and a delay in diagnosis.”
After three straight down days – and four out of the last five – shares of MYGN have eked up 1.65% in early trading Wednesday morning at $25.19.