Myriad Advances MRD Commercialization Timeline, Bolstered by New Study Data

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) plans a limited clinical launch of Precise MRD in March 2026, starting with breast cancer and expanding to colorectal and renal cancers later in 2026, with potential further expansion in 2027.

Key study data show ultrasensitive ctDNA detection down to 1 part-per-million, 93% baseline sensitivity in MONITOR-Breast, and 100% baseline detection plus 100% one-month post-surgery sensitivity for recurrence prediction in MONSTAR-SCREEN-3; one-month postoperative ctDNA positivity was linked to shorter disease-free survival (median follow-up ~6 months, p<0.001).

Positive

• Limited clinical launch scheduled for March 2026
• Detection down to 1 ppm ctDNA sensitivity
• 93% baseline sensitivity reported in MONITOR-Breast
• 100% baseline detection and 100% recurrence prediction sensitivity in MONSTAR-SCREEN-3

Negative

• Initial rollout limited to select community clinicians, constraining near-term scale
• Key results are interim analyses rather than final long-term outcomes
• Median follow-up of approximately six months for recurrence data

Key Figures

Baseline sensitivity (breast): 93% Ultrasensitive baseline samples: 21% Ultrasensitive post-therapy samples: 73% +5 more

8 metrics

Baseline sensitivity (breast) 93% MONITOR-Breast baseline ctDNA detection with Precise MRD

Ultrasensitive baseline samples 21% Baseline breast ctDNA samples detected below 100 ppm

Ultrasensitive post-therapy samples 73% Post-neoadjuvant breast ctDNA samples detected below 100 ppm

Detection limit 1 part-per-million Precise MRD ctDNA detection threshold described as ultrasensitive

Baseline detection (colorectal) 100% Universal baseline ctDNA detection in MONSTAR-SCREEN-3

Ultrasensitive range samples 20% Colorectal baseline samples in ultrasensitive ctDNA range

Recurrence prediction sensitivity 100% Sensitivity at one-month post-surgery for colorectal recurrence prediction

Significance level p<0.001 Association of ctDNA status with disease-free survival in colorectal cancer

Market Reality Check

Price: $5.81 Vol: Volume 738,617 is at 0.81...

normal vol

$5.81 Last Close

Volume Volume 738,617 is at 0.81x the 20-day average of 915,301 shares. normal

Technical Shares trade below the 200-day MA, at 5.81 vs 200-day MA of 6.29.

Peers on Argus

Peers show mixed moves: FLGT -1.04%, NEO -2.51%, while CDNA, CSTL, and PSNL are ...

Peers show mixed moves: FLGT -1.04%, NEO -2.51%, while CDNA, CSTL, and PSNL are up between 0.78% and 1.87%, suggesting MYGN’s -1.02% move is more stock-specific.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Prelim earnings, guidance	Positive	-0.1%	Released preliminary 2025 results and introduced detailed full-year 2026 financial guidance.
Jan 05	Investor conference	Neutral	+0.0%	Announced CEO presentation at the 44th Annual J.P. Morgan Healthcare Conference.
Dec 09	MRD, SABCS data	Positive	+4.0%	Highlighted eight abstracts at SABCS 2025, including ultra-sensitive Precise MRD data.
Nov 25	AI risk platform	Positive	-3.9%	Launched integrated AI and genetic breast risk platform with Clairity and MagView.
Nov 11	Investor conferences	Neutral	+3.1%	Planned participation in Wolfe Research and Piper Sandler healthcare conferences.

Pattern Detected

Recent news often shows mixed alignment: positive clinical/strategic updates have sometimes been followed by both gains and pullbacks.

Recent Company History

Over the last few months, Myriad has focused on financial visibility and oncology innovation. Preliminary Q4 2025 and full‑year 2025 results with 2026 guidance, multiple MRD‑related presentations at SABCS 2025, and an AI‑enabled breast risk platform have all highlighted a pivot toward precision oncology and improved economics. Today’s MRD commercialization roadmap builds directly on the MRD data presented at SABCS 2025 and at major oncology meetings.

Market Pulse Summary

This announcement outlines a clear commercialization path for Precise MRD, backed by strong breast a...

Analysis

This announcement outlines a clear commercialization path for Precise MRD, backed by strong breast and colorectal ctDNA data, including 93% baseline sensitivity and 100% recurrence prediction sensitivity at one month. It builds on prior MRD presentations at SABCS and ASCO GI, reinforcing Myriad’s precision oncology focus. Investors may watch execution of the March 2026 limited launch, future cancer-type expansions, and continued outcome data linking ctDNA dynamics to disease-free survival.

Key Terms

molecular residual disease, circulating tumor dna, ctdna, neoadjuvant therapy, +4 more

8 terms

molecular residual disease medical

"commercialization roadmap for its Precise MRD™ (molecular residual disease) assay"

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

circulating tumor dna medical

"clinical value of ultrasensitive circulating tumor DNA (ctDNA) detection across cancer types"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

ctdna medical

"ability to detect ctDNA down to one part-per-million (ppm)"

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

neoadjuvant therapy medical

"assessed ctDNA using Precise MRD ... at frequent intervals during neoadjuvant therapy"

Neoadjuvant therapy is medicine given before the main treatment—usually drugs, radiation, or both—aimed at shrinking a tumor or improving surgical outcomes. For investors it signals a strategic step in a drug’s development and commercial path: successful neoadjuvant results can make a treatment easier to use, expand its approved indications, and increase market value much like priming soil before planting improves the eventual harvest.

whole-genome sequencing medical

"Precise MRD, a tumor-informed whole-genome sequencing (WGS)-based assay"

Whole-genome sequencing is the process of reading an organism’s entire DNA instruction manual to capture all genetic information rather than just selected parts. For investors, it matters because having the full genetic picture can reveal new diagnostics, drug targets, or personalized treatments that drive product value, regulatory approvals, and long-term revenue potential, while improvements in speed and cost can expand market reach like making a complex map easier and cheaper to produce.

wgs medical

"Precise MRD, a tumor-informed whole-genome sequencing (WGS)-based assay"

Whole genome sequencing (WGS) is a laboratory method that reads an individual’s complete DNA instruction set, capturing all genetic differences across the genome; think of it as scanning an entire instruction manual instead of inspecting only a few pages. For investors, WGS matters because it can enable broader diagnostics, guide targeted drug development, and create new clinical and commercial opportunities—so firms using or offering WGS may have different growth potential, regulatory paths, and risk profiles than those relying on limited genetic tests.

pathological complete response medical

"ctDNA negativity, was significantly associated with pathological complete response"

Pathological complete response is when tissue examined under a microscope after cancer treatment and surgery shows no remaining invasive tumor cells. Investors care because it is a strong signal that a therapy is working, often used as a key endpoint in clinical trials and a predictor of better long‑term outcomes; like finding an empty crime scene after a cleanup, it can boost confidence in a drug’s market potential and regulatory prospects.

disease-free survival medical

"ctDNA positivity at one-month post-surgery was associated with significantly shorter disease-free survival"

Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.

AI-generated analysis. Not financial advice.

Precise MRD™ to transition from research-use-only into a limited clinical launch in March 2026

SALT LAKE CITY, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced a commercialization roadmap for its Precise MRD™ (molecular residual disease) assay and highlighted compelling data that reinforces the clinical value of ultrasensitive circulating tumor DNA (ctDNA) detection across cancer types.

Myriad will launch Precise MRD with select community-based clinicians in March 2026 in breast, followed by colorectal and renal cancers later this year. The company may expand into additional cancer types, including ovarian and endometrial in 2027 and beyond.

“Our Precise MRD program reflects Myriad’s unwavering commitment to advancing precision oncology by bringing ultrasensitive MRD testing into real-world clinical care,” said Sam Raha, President and CEO, Myriad Genetics. “By detecting ctDNA at extremely low levels and demonstrating a clear link to clinical outcomes, this limited clinical launch represents meaningful progress toward earlier insight, more informed decisions, and better outcomes for patients.”

This timeline reflects the clinical evidence demonstrating Precise MRD’s high sensitivity and ability to detect ctDNA down to one part-per-million (ppm). Interim study analyses have suggested near-universal baseline detection and recurrence prediction in colorectal cancer, as well as high baseline sensitivity in breast cancer.

The growing body of evidence behind Precise MRD and the increasing role of ultrasensitive MRD testing in clinical practice has been shared across multiple leading scientific and industry forums, including publication in The Lancet Oncology, presentations at the 2025 San Antonio Breast Cancer Symposium^® (SABCS) and the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, and the introduction of Myriad’s MRD strategy at the J.P. Morgan Healthcare Conference.

Study Findings
MONITOR-Breast is a prospective, multicenter observational study evaluating patients with Stage I-III breast cancer across all subtypes. The study systematically assessed ctDNA using Precise MRD, a tumor-informed whole-genome sequencing (WGS)-based assay, at frequent intervals during neoadjuvant therapy, with a median of 10 timepoints per patient. This design enabled a high-resolution, longitudinal analysis of ctDNA dynamics across the neoadjuvant treatment course. Results shared at SABCS demonstrated:

• High baseline sensitivity: 93% baseline sensitivity, with high detection rates across stage, nodal status, or subtype.
• Ultrasensitive detection: 21% of baseline samples and 73% of post-neoadjuvant therapy ctDNA samples were detected at levels below 100 ppm, a range typically below the threshold of first-generation assays.
• Early clearance predicts response: Clearance of ctDNA by day 50 of neoadjuvant therapy, followed by sustained ctDNA negativity, was significantly associated with pathological complete response.
• Persistent ctDNA positivity predicts residual disease: Ongoing or intermittent ctDNA positivity throughout the neoadjuvant period, even at ctDNA levels below 20 ppm, was significantly associated with residual disease.

At ASCO^® GI, collaborators from the National Cancer Center Hospital East in Japan reported interim key outcomes from MONSTAR-SCREEN-3, a multi-center, prospective study of patients with resectable Stage I-IV colorectal cancer that incorporates Precise MRD:

• Universal baseline detection: 100% baseline ctDNA detection across all patients with 20% of samples identified at levels in the ultrasensitive range.
• High sensitivity for recurrence prediction: 100% sensitivity at one-month post-surgery in predicting recurrence.
• Postoperative prognostic significance: ctDNA positivity at one-month post-surgery was associated with significantly shorter disease-free survival over a median follow-up of approximately six months (p<0.001).
• Quantitative risk stratification: Patients with ctDNA levels above 100 ppm experienced significantly worse disease-free survival than those with lower level ctDNA detection, demonstrating the importance of an ultra sensitive assay (p<0.001).

About Precise MRD
Precise MRD is Myriad’s tumor-informed circulating tumor DNA (ctDNA) assay designed to support longitudinal monitoring after cancer treatment. Using whole-genome sequencing to create a personalized assay for each patient, Precise MRD enables ultrasensitive detection of ctDNA down to one part per million.

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 Oncology, Myriad provides a portfolio of advanced genetic and tumor genomic testing solutions including risk assessment, screening, tools to aid treatment guidance, and survivorship. For more information, visit www.myriad.com.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s plans to launch Precise MRD with select community-based clinicians in March 2026 in breast, followed by colorectal and renal cancers later this year, with potential expansion into additional cancer types, including ovarian and endometrial in 2027 and beyond, and statements that the Precise MRD program reflects the company’s unwavering commitment to advancing precision oncology by bringing ultrasensitive MRD testing into real-world clinical care and that this limited clinical launch represents meaningful progress towards earlier insight, more informed decisions, and better outcomes for patients. 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

When will Myriad (MYGN) begin the Precise MRD clinical launch?

Myriad will begin a limited clinical launch of Precise MRD in March 2026, starting in breast cancer.

What ctDNA sensitivity does Precise MRD (MYGN) report?

The assay reports ultrasensitive detection down to 1 part-per-million (ppm) with high baseline sensitivity in studies.

What were the MONITOR-Breast study findings relevant to MYGN's Precise MRD?

MONITOR-Breast showed 93% baseline sensitivity and that early ctDNA clearance predicted pathological complete response.

What colorectal outcomes were reported for Precise MRD at ASCO GI?

MONSTAR-SCREEN-3 reported 100% baseline detection and 100% sensitivity at one month post-surgery for recurrence prediction.

How strong is the postoperative prognostic evidence for Precise MRD (MYGN)?

Postoperative ctDNA positivity at one month was associated with significantly shorter disease-free survival (p<0.001) over ~six months median follow-up.