Myriad Genetics Applauds New Guidelines Recommending Screening for Chromosomal Abnormalities

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) is advancing non-invasive prenatal screening (NIPS) with its products Prequel and the upcoming FirstGene test, leveraging AMPLIFY technology. The recent update by the American College of Medical Genetics and Genomics (ACMG) endorses NIPS for various chromosomal abnormalities. Prequel already screens for sex-chromosome aneuploidies and microdeletions, enhancing accuracy through increased fetal fraction. The new FirstGene test will combine multiple screening modalities into a single blood draw, expected to launch in Q3 2023, offering significant improvements in prenatal screening.

Positive

• Launch of FirstGene test expected in Q3 2023, enhancing ease of prenatal screening.
• Prequel test utilizes AMPLIFY technology, improving accuracy by increasing fetal fraction above 20%.
• ACMG's strong recommendation for NIPS supports future growth and market demand.

Negative

• None.

• Myriad Genetics continues to advance non-invasive prenatal screening with Prequel^® and the forthcoming FirstGene™ test using AMPLIFY™ technology

SALT LAKE CITY, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced its support for a recent guideline update by the American College of Medical Genetics and Genomics (ACMG), reaffirming the clinical value of non-invasive prenatal screening (NIPS) for a range of chromosomal abnormalities. Myriad is dedicated to advancing NIPS with best-in-class technology and important product launches.

ACMG continues to recommend offering screening for common trisomies (on chromosomes 13, 18, and 21) in all pregnancies, and newly updated guidance now provides a strong recommendation for offering screening for sex-chromosome aneuploidies (SCAs) and conditional support for offering screening for 22q microdeletion syndrome.

Myriad Genetics’ Prequel NIPS already offers this screening for SCAs and common microdeletions, such as 22q, for physicians and patients who opt-in, providing a flexible option that is consistent with ACMG's recommendations. Prequel is the only NIPS to use Myriad’s proprietary AMPLIFY™ technology, which makes it easier to identify chromosomal abnormalities in the fetus by substantially increasing fetal fraction (the share of cell-free DNA originating from fetal tissue).

In today’s announcement, Myriad Genetics also confirmed the upcoming product launch of FirstGene, an innovation that will enhance the ease-of-use and utility of prenatal screening by combining multiple screening modalities into one test performed entirely on a single blood draw from a pregnant person. FirstGene is a 4-in-1 offering that includes NIPS for chromosomal abnormalities, carrier screening for recessive conditions, simultaneous single-gene assessment of whether the fetus is affected with a condition identified via carrier screening, and feto-maternal blood compatibility. As part of the NIPS within FirstGene, both SCAs and 22q will be available for opt-in.

“We’re excited to introduce our FirstGene product in Q3 2023,” said Melissa Gonzales, President, Women’s Health, Myriad Genetics. “FirstGene employs our proprietary AMPLIFY™ technology to achieve the same best-in-class accuracy as Prequel, and will include additional enhancements to improve performance for all fetal chromosome abnormalities, including the common trisomies, SCAs, and 22q. Key components of FirstGene are within guidelines and supported by established reimbursement practices.”

“Microdeletions such as 22q can be very difficult to identify when fetal fraction is less than 8%, which is the average fetal fraction on NIPS offerings without AMPLIFY technology,” said Dr. Dale Muzzey, Chief Scientific Officer, Myriad Genetics. “However, Myriad’s Prequel NIPS with AMPLIFY technology provides more accurate results because nearly all samples tested with AMPLIFY technology are above 8% fetal fraction. The average fetal fraction with AMPLIFY is above 20%, more than double the level where microdeletions become very hard to detect.”

Dr. Muzzey added, “We are currently assessing the positive predictive value (PPV) of Prequel’s 22q screening based on clinical outcomes, and we plan to present our progressively growing data set at several high-profile conferences in 2023. We are very encouraged to see that initial data supports our view that Prequel provides exemplary PPV for 22q screening via NIPS.”

About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. Fast Company named Myriad among the World’s Most Innovative Companies for 2022. For more information, visit www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, Colaris AP, MyRisk, Myriad MyRisk, MyRisk Hereditary Cancer, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, FirstGene, SneakPeek, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are trademarks or registered trademarks of Myriad Genetics, Inc. © 2022 Myriad Genetics, Inc. All rights reserved.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the forthcoming FirstGene test using AMPLIFY technology, which is expected to be launched in the third quarter of 2023, the benefits of the FirstGene test, including enhanced ease-of-use and utility and that the FirstGene test will include additional enhancements to improve performance for all fetal chromosome abnormalities, the components of the FirstGene product, the initial data supports the company’s view that Prequel provides exemplary PPV for 22q screening via NIPS, and the company’s plan to present its growing data set at several high-profile conferences in 2023. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to a number of known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 25, 2022, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

Media Contact:	Investor Contact:
Glenn Farrell	Matt Scalo
(801) 584-1153	(801) 584-3532
Glenn.Farrell@myriad.com	Matt.Scalo@myriad.com

FAQ

What is the significance of Myriad Genetics' <b>Prequel</b> test for prenatal screening?

The Prequel test offers advanced non-invasive prenatal screening for chromosomal abnormalities, utilizing AMPLIFY technology to enhance accuracy.

When is the <b>FirstGene</b> test from Myriad Genetics expected to launch?

The FirstGene test is expected to launch in the third quarter of 2023.

How does <b>AMPLIFY</b> technology improve prenatal screening accuracy?

AMPLIFY technology increases the fetal fraction, significantly enhancing the detection of chromosomal abnormalities.

What new features does the <b>FirstGene</b> test offer compared to previous tests?

The FirstGene test combines multiple screening modalities into one test, performed entirely on a single blood draw.

What recent guideline update supports Myriad Genetics’ NIPS products?

The American College of Medical Genetics and Genomics (ACMG) updated guidelines to strongly recommend screening for sex-chromosome aneuploidies and offer conditional support for 22q microdeletion syndrome.