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Myriad Genetics Reports Favorable Study Result on Prequel

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Myriad Genetics, Inc. MYGN publishes favorable study results on the Prequel Prenatal Screen in the journal Prenatal Diagnosis. The highlight of the study is to prove the superiority of Prequel over the traditional non-DNA screening used for identifying chromosomal abnormalities in pregnant women, including those with high body mass index (BMI).

Per the company, almost half the population of pregnant women have a BMI that can adversely affect the accuracy of the non-invasive prenatal screening (NIPS). This, in turn, leads to patient anxiety, and more expensive and invasive screening methods like amniocentesis or chorionic villus sampling.

With the positive outcome of NIPS, Myriad Genetics aims to strengthen foothold in the global NIPS test market — a segment of the company’s molecular diagnostic testing business.


About the Study

Prequel’s performance is based on the whole genome sequencing (WGS) approach, which identifies chromosomal irregularities like trisomy 21 (T21), trisomy 18 (T18) and trisomy 13 (T13). The Prequel screen uses cell-free DNA (cfDNA) to decide whether the pregnancy is at an increased risk for chromosome abnormalities, such as Down syndrome.

The Prequel Prenatal Screen: A Breakthrough

According to the previous results of the study, Prequel is accurate at all FF levels and does not necessitate a FF cutoff like other NIPS offerings. However, in the current study, the company has demonstrated the efficacy of Prequel in all women, irrespective of their BMI, race or ethnicity. This is an upgrade from the traditional NIPS, which had a higher fetal fraction (FF) cutoff and non-DNA screening methods.

It also indicated that the tests that are required to use a FF cutoff may actually underperform at higher BMIs, unlike the Prequel. This, in turn, will ease patient’s anxiety to some extent after the first screening itself, accelerating diagnosis.

Industry Prospects

Per a report by MarketsAndMarkets, the global non-invasive prenatal testing market is projected to reach $7.3 billion by 2024 from $3.9 billion in 2019, witnessing a CAGR of 13.5% between 2019 and 2024. The key drivers of the market are the high risk of chromosomal abnormalities with increasing maternal age and growing preference for non-invasive techniques over invasive methods, to name a few.

Given the huge potential of the NIPS test market, the study result has been published at the right time.

Recent Developments in Molecular Diagnostic

Myriad Genetics received the Ministry of Health, Labour and Welfare of Japan’s approval for the BRACAnalysis Diagnostic System (BRACAnalysis) in November. This is expected to help determine which women with breast cancer have Hereditary Breast and Ovarian Cancer (HBOC) syndrome and thus qualify for additional medical management.

In the same month, the company’s Vectra test was included in the American College of Rheumatology’s new recommendations on disease activity measures for patients with rheumatoid arthritis (RA).

The favorable outcome of the Prequel Prenatal Screen and GUIDED clinical trial were earlier published in the online journals Ultrasound in Obstetrics and Gynecology, and The Journal of Clinical Psychiatry, respectively, this November. The latter study focused on the improvement of clinical results (remission, response and symptoms) of the GeneSight Psychotropic test in patients taking medications with gene-drug interactions.

In February, the company announced the enhancement of the Prequel system to include all 23 chromosome pairs rather than just the standard five chromosomes (13, 18, 21, X and Y), previously tested.

Price Performance

Shares of Myriad Genetics have declined 19.6% in the past year compared with the industry’s 6.5% fall.

Zacks Rank & Stocks to Consider

Currently, Myriad Genetics has a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are NuVasive, Inc NUVA, National Vision Holdings, Inc EYE and ResMed Inc (RMD - Free Report) .

NuVasive currently has a Zacks Rank #2 (Buy) and a projected long-term earnings growth rate of 12.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2.

ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently sports a Zacks Rank #1.

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