FirstGene Study Demonstrates High Analytical Sensitivity and Specificity for Each Component of the Test

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) announced publication of the analytical validation of the FirstGene Multiple Prenatal Screen in Clinical Chemistry on February 19, 2026. Using nearly 500 samples, the study reported each test component achieved ≥98.2% analytical sensitivity and ≥99.0% analytical specificity.

The assay evaluates fetal aneuploidy, RhD compatibility, and recessive condition status for the pregnant person and fetus across 19 prevalent severe conditions. The test uses fetal-fraction amplification and a trajectory analysis algorithm to improve genotype resolution and reproducibility, which the company says supports broader commercialization efforts.

Positive

• Analytical sensitivity ≥98.2% across all test components
• Analytical specificity ≥99.0% across all test components
• Validation used nearly 500 samples, including fetal and maternal assessments
• Covers 19 prevalent, severe recessive conditions in one integrated screen
• Employs fetal-fraction amplification and a novel trajectory algorithm

Negative

• None.

News Market Reaction – MYGN

-0.34%

1 alert

-0.34% News Effect

On the day this news was published, MYGN declined 0.34%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Sample size: nearly 500 samples Conditions covered: 19 conditions Analytical sensitivity: ≥98.2% +1 more

4 metrics

Sample size nearly 500 samples Analytical validation of FirstGene Multiple Prenatal Screen

Conditions covered 19 conditions Recessive condition status in pregnant person and fetus

Analytical sensitivity ≥98.2% Each component of FirstGene test

Analytical specificity ≥99.0% Each component of FirstGene test

Market Reality Check

Price: $4.38 Vol: Volume 819,850 versus 20-...

normal vol

$4.38 Last Close

Volume Volume 819,850 versus 20-day average 947,924, indicating somewhat muted trading interest ahead of this news. normal

Technical Shares at $4.37, trading below the $6.09 200-day MA and sitting closer to the 52-week low of $3.76 than the high of $15.47.

Peers on Argus

Pre-news, MYGN was down 2.89% while peers showed mixed moves: FLGT and NEO down,...

Pre-news, MYGN was down 2.89% while peers showed mixed moves: FLGT and NEO down, CDNA and PSNL up, and CSTL roughly flat, pointing to stock-specific dynamics rather than a unified diagnostics sector trend.

Historical Context

5 past events · Latest: Feb 16 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 16	Earnings timing update	Neutral	+0.2%	Announced date and call details for Q4 and full-year 2025 results.
Jan 27	MRD data update	Positive	+1.9%	Shared new Precise MRD study data and commercialization timing plans.
Jan 12	Prelim results, guidance	Positive	-0.1%	Released preliminary Q4/2025 revenue ranges and 2026 financial guidance.
Jan 05	Conference appearance	Neutral	+0.0%	Announced presentation at the 44th Annual J.P. Morgan Healthcare Conference.
Dec 09	Scientific presentations	Positive	+4.0%	Detailed 8 abstracts on MRD and hereditary cancer testing at SABCS.

Pattern Detected

MYGN has generally reacted positively to data- and study-focused announcements, while preliminary financial updates have shown at least one instance of negative price reaction.

Recent Company History

Over the last few months, MYGN has mixed operational and financial catalysts. Positive scientific and clinical updates, such as MRD data and SABCS abstracts, were followed by modest gains, while preliminary 2025 results and 2026 guidance saw a slight decline. Earnings-date logistics and conference appearances have had minimal impact. Against this backdrop, the strong analytical validation for FirstGene adds to a series of data-driven milestones as the company advances its testing portfolio, alongside upcoming detailed 2025 financials on Feb. 23, 2026.

Market Pulse Summary

This announcement highlights strong analytical validation for the FirstGene Multiple Prenatal Screen...

Analysis

This announcement highlights strong analytical validation for the FirstGene Multiple Prenatal Screen, with all test components achieving at least 98.2% sensitivity and 99.0% specificity across nearly 500 samples and 19 severe conditions. In recent months, MYGN has complemented financial updates with multiple data-driven milestones. Investors may watch how this validation supports future commercialization, interacts with upcoming 2025 financial results, and fits into the broader shift in Myriad’s diagnostics portfolio and technology stack.

Key Terms

analytical sensitivity, analytical specificity, cfdna, aneuploidy, +3 more

7 terms

analytical sensitivity medical

"It found that every component of the test had ≥98.2% analytical sensitivity and ≥99.0%..."

Analytical sensitivity is the smallest amount of a substance—like a virus particle, protein or chemical—that a lab test can reliably detect. Think of it as how faint a whisper a microphone can pick up: higher sensitivity means the test finds lower levels of the target. For investors, sensitivity affects a test’s clinical usefulness, regulatory approval chances, market competitiveness and potential revenue, as well as the credibility of reported results.

analytical specificity medical

"It found that every component of the test had ≥98.2% analytical sensitivity and ≥99.0% analytical specificity."

Analytical specificity measures how well a diagnostic test or laboratory assay avoids reacting to substances it should ignore — in other words, how rarely it gives a positive result for the wrong thing. For investors, high specificity means fewer false positives, which lowers the risk of costly recalls, regulatory problems, or damaged reputation and supports clearer market demand for the product, similar to a smoke detector that only alarms for real smoke and not harmless steam.

cfdna medical

"Titled “Simultaneous prenatal cfDNA screening of aneuploidy, recessive single-gene conditions..."

Cell-free DNA (cfDNA) is short fragments of genetic material that float freely in the bloodstream after cells die and release their contents. Investors care because cfDNA can be sampled with a simple blood draw to reveal signs of pregnancy complications, organ damage, or cancer without invasive procedures, making it the basis for high-growth diagnostic tests, monitoring tools and companion products that can change how diseases are detected and treated.

aneuploidy medical

"Simultaneous prenatal cfDNA screening of aneuploidy, recessive single-gene conditions..."

Aneuploidy is a condition in which cells have an abnormal number of chromosomes—too many or too few—like a deck of cards missing or repeating certain cards. It matters to investors because it underlies many cancers and genetic disorders, affects how diseases progress, and can determine whether diagnostic tests or drugs work; treatments targeting aneuploidy or tests that detect it can drive clinical value and commercial opportunities.

rhd compatibility medical

"including fetal aneuploidy testing, RhD compatibility, and recessive condition status..."

RhD compatibility describes whether a blood donor and recipient (or a pregnant person and their fetus) have matching Rhesus D status — the presence or absence of a specific protein on red blood cells. Like matching plug types before joining electrical cords, ensuring RhD compatibility prevents an immune reaction that can destroy blood cells. Investors watch this because compatibility affects demand for specialized blood products, diagnostics and treatments, regulatory approvals, and the size of addressable markets for blood-related medical products.

fetal-fraction amplification medical

"Like our Prequel test, the FirstGene screen employs fetal-fraction amplification to improve accuracy..."

Fetal-fraction amplification is a laboratory method used in non-invasive prenatal testing to increase the proportion of fetal DNA in a blood sample taken from the mother. By boosting the fetal signal relative to the mother’s background DNA—like turning up a weak radio station so you hear it clearly—it makes genetic screening more reliable, reduces inconclusive results, and can expand the number of pregnancies that can be accurately tested, which matters to investors tracking test adoption, reimbursement, and market size.

genotype medical

"can help further enhance genotype resolution. Publishing these results marks an important milestone..."

The genotype is an organism’s set of genes — its genetic makeup — that helps determine traits and how it responds to drugs or diseases. For investors, genotype matters because genetic differences can shape whether a therapy works, which patients are eligible, and how large or specialized a market will be; think of it like a product’s compatibility list that decides who can use it and how well it performs.

AI-generated analysis. Not financial advice.

Analytical validation of FirstGene Multiple Prenatal Screen published in Clinical Chemistry

SALT LAKE CITY, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, announced the publication of the analytical validation of the FirstGene^® Multiple Prenatal Screen in Clinical Chemistry. The study showed that each component of the test had exceptional sensitivity and specificity.

Titled “Simultaneous prenatal cfDNA screening of aneuploidy, recessive single-gene conditions, and fetomaternal blood compatibility,” the study used nearly 500 samples to assess the multiple components of the FirstGene screen, including fetal aneuploidy testing, RhD compatibility, and recessive condition status in the pregnant person and fetus, including 19 prevalent and severe conditions. It found that every component of the test had ≥98.2% analytical sensitivity and ≥99.0% analytical specificity.

“The FirstGene screen was designed as an integrated, multifaceted solution that analyzes key aspects of the maternal and fetal genomes simultaneously,” said Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. “For clinicians to have confidence in, and consider acting on, FirstGene results, it is important that every component of the assay have strong accuracy and reproducibility, which is why we undertook extensive analytical validation. Our analysis adds important evidence in the rapidly evolving landscape of prenatal screening tests, particularly because it provides a thorough characterization of the ability to call fetal recessive genotypes—even technically challenging variants—with high accuracy.”

“Like our Prequel test, the FirstGene screen employs fetal-fraction amplification to improve accuracy,” said Dr. Muzzey. “This publication describes how that approach, together with a novel trajectory analysis algorithm developed for the FirstGene screen, can help further enhance genotype resolution. Publishing these results marks an important milestone on the path to broad commercialization.”

About the FirstGene Multiple Prenatal Screen
Medical society guidelines recommend aneuploidy screening, recessive screening, and fetomaternal antigen testing.^1-3 However, fewer than half of pregnancies in the US receive screening for each of these recommended modalities individually, which may be driven in part by the logistical difficulty of administering the tests.^4-6 The FirstGene screen aims to streamline prenatal genetic risk assessment by combining each of these testing modalities into a single assay.

The FirstGene screen is currently being used in the CONNECTOR study, a large, multi-site, prospective clinical study designed to evaluate test performance in real‑world clinical practice. The study is designed to generate evidence to support clinical validity and clinical utility across the multiple components of the assay as FirstGene advances toward full commercial launch.

The FirstGene screen will be conducted in-house at Myriad’s laboratories using a single blood draw from the pregnant person. More information is available at FirstGeneScreen.com.

1. ACOG Practice Bulletin Summary, No. 226: Screening for fetal chromosomal 385 abnormalities. Obstet Gynecol 2020;136(4):859-67. 386;
2. ACOG Committee Opinion No. 691: Carrier screening for genetic conditions 2017. 387
3. Gregg AR, Aarabi M, Klugman S, Leach NT, Bashford MT, Goldwaser T, et al. Screening 388 for autosomal recessive and X-linked conditions during pregnancy and preconception: a 389 practice resource of the American College of Medical Genetics and Genomics (ACMG). 390 Genet Med 2021;23,1793-1806.
4. Prenatal Diagnosis 2020 Feb;40(3):311-316. doi: 10.1002/pd.5588. Epub 2019 Dec 2
5. Journal of Genetic Counseling. 2021 Apr;30(2):470-477. doi: 10.1002/jgc4.1333. Epub 2020 Oct 3
6. Prenatal Diagnosis. 2021 Jun;41(7):896-904. doi: 10.1002/pd.5900. Epub 2021 Feb 8

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

Myriad Genetics Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements that publishing these results marks an important milestone on the path to broad commercialization of FirstGene, that the CONNECTOR study is designed to generate evidence to support clinical validity and clinical utility across the multiple components of the assay as FirstGene advances toward full commercial launch, and that the FirstGene screen aims to streamline prenatal genetic risk assessment by combining each of the above mentioned testing modalities into a single assay. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to 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 28, 2025, 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. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. 

Investor Contact 
Matt Scalo 
(801) 584-3532 
IR@myriad.com 

Media Contact 
Kate Schraml
(224) 875-4493
PR@myriad.com  

FAQ

What analytical sensitivity and specificity did Myriad Genetics report for FirstGene (MYGN) on Feb 19, 2026?

The FirstGene analytical validation reported ≥98.2% sensitivity and ≥99.0% specificity. According to the company, these metrics applied to each component of the multi-part prenatal screen across nearly 500 validation samples.

Which prenatal conditions and components does the FirstGene screen (MYGN) evaluate in the Feb 19, 2026 study?

FirstGene evaluates fetal aneuploidy, RhD fetomaternal compatibility, and recessive condition status. According to the company, the validation included testing for 19 prevalent, severe recessive conditions in pregnant persons and fetuses.

How large was the validation cohort for the FirstGene Multiple Prenatal Screen (MYGN) published Feb 19, 2026?

The study used nearly 500 samples to assess assay components and performance. According to the company, that sample set supported analytical estimates of sensitivity and specificity for each component.

What technical methods does Myriad say improve FirstGene (MYGN) accuracy in the Feb 19, 2026 report?

The FirstGene screen uses fetal-fraction amplification plus a novel trajectory analysis algorithm to enhance genotype resolution. According to the company, these approaches help improve accuracy and reproducibility for challenging variant calls.

Does the Feb 19, 2026 publication claim FirstGene (MYGN) is ready for commercialization?

The company said publishing analytical validation is an important milestone toward broad commercialization. According to the company, the results support further commercial development but do not specify timing or regulatory steps.

What does the Feb 19, 2026 validation mean for clinicians using FirstGene (MYGN)?

The validation indicates each test component demonstrated high analytical accuracy and reproducibility. According to the company, clinicians can have increased confidence in component-level calls for aneuploidy, RhD, and selected recessive genotypes.