Myriad Genetics, Inc. (MYGN) SWOT Analysis

Myriad Genetics, Inc. (MYGN): SWOT Analysis [Nov-2025 Updated]

US | Healthcare | Medical - Diagnostics & Research | NASDAQ
Myriad Genetics, Inc. (MYGN) SWOT Analysis

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You're tracking Myriad Genetics, Inc. (MYGN) because you know 2025 is a make-or-break year for their strategic pivot. They've successfully diversified beyond their legacy test, with GeneSight revenue defintely on track to exceed $230 million, which is a massive strength. But that move hasn't solved the core profitability puzzle yet, and the market is brutal, with lower-cost competitors constantly chipping away at margins, even as the company targets a full-year adjusted EPS of $0.15 to $0.25. If you want to understand the real risks and the clear opportunities driving that valuation right now, you need to see the full SWOT breakdown.

Myriad Genetics, Inc. (MYGN) - SWOT Analysis: Strengths

Established brand in hereditary cancer testing (myRisk)

Myriad Genetics holds a powerful, established position in hereditary cancer testing, primarily through its MyRisk Hereditary Cancer Test. This test is widely considered the gold standard in germline testing, which is a major strength because it means clinicians trust the results and the data behind them.

The company aggressively maintains this lead, expanding the MyRisk panel in November 2025 to include 63 genes across more than 11 cancer types, covering 100% of genes strongly recommended by national oncology guidelines from organizations like NCCN (National Comprehensive Cancer Network) and ASCO (American Society of Clinical Oncology). This commitment to clinical utility is why MyRisk Hereditary Cancer Testing volumes in the affected population grew by a strong 14% year-over-year in the second quarter of 2025. For the full 2025 fiscal year, hereditary cancer testing is projected to generate approximately $370 million in revenue, which is about 45% of the company's total sales. That is a serious cornerstone of the business.

Strong volume growth in GeneSight, with Q3 2025 revenue of $38.7 million

While the pharmacogenomics (PGx) market has faced payer headwinds, the underlying strength of the GeneSight product-which helps guide treatment for depression and other mental health conditions-remains a key asset. The test's volume growth is a clear indicator of its clinical demand. In the third quarter of 2025, GeneSight test volume grew 8% year-over-year, demonstrating a clear market recovery and physician adoption following earlier payer policy changes.

This volume growth translated into a Q3 2025 revenue of $38.7 million for the GeneSight test. This is a critical strength because it shows the product can regain traction even after a major insurer like UnitedHealthcare discontinued coverage for multi-gene panel PGx tests earlier in 2025. The continued, defintely solid performance in Q3 2025 proves the test's value proposition is resonating with clinicians who need better tools for mental health care. The market is still there, you just have to fight for it.

Extensive data repository and clinical validation for key tests

Myriad Genetics' most powerful, unassailable strength is its proprietary data and the clinical validation that underpins its test portfolio. This isn't just a lab; it's a data engine. The company maintains the largest repository of comparative data covering all ancestries, which is vital for providing accurate results across a diverse patient population.

The Myriad Collaborative Research Registry (MCRR) is pre-loaded with de-identified data on over 1.1 million patients, combining genetic/genomic results with structured clinical data. This massive dataset allows for ongoing research and the continuous improvement of its testing algorithms. For instance, the MyRisk test delivers unmatched accuracy, with variant classification techniques independently verified and clinically validated at >99.9% accuracy. This level of precision is a high barrier to entry for competitors and gives clinicians confidence in the results, which is something you can't buy overnight.

Key Clinical Data Points for Myriad Genetics' Tests (FY 2025)
Test/Data Asset Key Metric (2025 Data) Value/Impact
MyRisk Hereditary Cancer Test Genes Covered (Expanded Nov 2025) 63 genes (100% of NCCN/ASCO strongly recommended genes)
MyRisk Hereditary Cancer Test Volume Growth (Q2 2025 Y-o-Y) 14% in the affected population
MyRisk with RiskScore Validation Data Validated with outcomes data from >130,000 patients across all ancestries
MyRisk Test Accuracy Variant Classification Accuracy >99.9% accuracy
Myriad Collaborative Research Registry (MCRR) Patient Data Repository Size De-identified data on >1.1 million patients

Diversified portfolio across mental health, women's health, and oncology

Myriad Genetics has successfully transitioned from being primarily a hereditary cancer company to a diversified precision medicine firm. This portfolio diversification across three major clinical areas-Oncology, Women's Health, and Mental Health-mitigates the risk of relying too heavily on any single product or payer policy.

The portfolio includes:

  • Oncology: MyRisk, Prolaris (prostate cancer), Precise Tumor, and the upcoming Precise MRD (minimal residual disease) assay.
  • Women's Health/Reproductive: Prequel Prenatal Screen, Foresight Carrier Screen, and FirstGene Multiple Prenatal Screen.
  • Mental Health: GeneSight.

This strategy is paying off, with the Women's Health segment showing strong performance; prenatal testing revenue grew by 11% year-over-year in the first quarter of 2025. The Oncology business alone delivered $81.8 million in revenue in Q3 2025. This breadth provides multiple avenues for growth and a more stable revenue base, even as new products like the AI-enabled Prolaris test and Precise MRD are targeted for launch in late 2025 and early 2026, respectively.

Myriad Genetics, Inc. (MYGN) - SWOT Analysis: Weaknesses

Historical struggle with consistent profitability and high operating expenses

You're looking at a company that has yet to prove it can translate high gross margins into consistent GAAP profitability. Myriad Genetics' historical weakness is its inability to sustain net income, which is a structural issue, not just a cyclical one. For the nine months ended September 30, 2025, the company reported a substantial GAAP net loss of -$400.5 million.

While the company is focused on adjusted metrics, the full-year 2025 guidance still projects a very tight Adjusted EPS range of $(0.02) to $0.02. This struggle is compounded by high operating expenses (OPEX). In 2024, total operating expenses were approximately $708.90 million. Even with cost-cutting, the company had to recognize significant impairment charges in the first nine months of 2025, including $234.7 million for goodwill and $82.0 million for intangible assets. That's a massive write-down that signals a need for strategic reassessment.

Heavy reliance on third-party payor reimbursement (getting paid is still the bottleneck)

The genetic testing business is defintely a reimbursement game, and Myriad Genetics remains heavily exposed to the policy whims of major third-party payors. Getting paid is still the biggest bottleneck. The most recent, concrete example is the policy change by UnitedHealthcare (UHC) in early 2025, which discontinued coverage for multi-gene panel pharmacogenetic tests like GeneSight.

This single policy shift caused the Pharmacogenomics (GeneSight) revenue to decline by a sharp 20% year-over-year in the first quarter of 2025. This one event was a $10 million headwind in Q1 2025 alone and forced the company to lower its full-year 2025 revenue guidance to a range of $807 - $823 million.

  • One payor change can slash revenue guidance by tens of millions.

Pricing pressure from competitors eroding gross margins

The core of the weakness here is that the genetic testing market is becoming commoditized, forcing prices down and eroding Myriad Genetics' traditionally high margins. The full-year 2025 Adjusted Gross Margin guidance was revised downward to a range of 68.5% - 69.5%, compared to an earlier forecast of 69.5%-70.5%.

This margin pressure is a direct result of competition. While the company is working on laboratory efficiencies, the pricing trends are a constant headwind. You see this in the Q3 2025 results, where the adjusted gross margin of 70.1% was slightly down from the 70.6% reported in Q3 2024. This is happening even as test volumes are growing, meaning the average revenue per test (ASPr) is under continuous strain.

Metric Initial FY 2025 Guidance Updated FY 2025 Guidance (May 2025) Implication
Revenue Range $840 - $860 million $807 - $823 million Significant revenue headwind from payor policy changes.
Adjusted Gross Margin % 69.5% - 70.5% 68.5% - 69.5% Pricing pressure and product mix are eroding margins.
Adjusted EBITDA $25 - $35 million $19 - $27 million Profitability outlook is materially lower and tighter.

Sales force integration challenges following recent product pushes

The company is aggressively pushing new products like Precise MRD and AI-enabled Prolaris, but commercial execution is a clear risk. Management has acknowledged the 'operational complexity and execution challenges' and is working on a timeline for 'strategic clarity and operational streamlining' into late Q3 or Q4 2025.

Specifically, the sales and commercial teams have struggled with integrating new systems. The ramp-up of hereditary cancer testing in unaffected populations faced 'slower-than-anticipated EMR integration ramp-ups' (Electronic Medical Record), which directly impacts sales workflow and test ordering. Plus, the prenatal segment saw challenges tied to a new order management system. This shows that even volume-driving initiatives can be hampered by internal commercial and IT execution.

Here's the quick math: you can have the best test in the world, but if the doctor's office can't order it easily through their EMR, the sales team can't hit their numbers. The company is investing $35 million in commercial capabilities, but the benefit of that investment is dependent on flawless execution, which has been a challenge in 2025.

Myriad Genetics, Inc. (MYGN) - SWOT Analysis: Opportunities

The core opportunities for Myriad Genetics lie in aggressively expanding reimbursement for its flagship mental health test, replicating its domestic Women's Health success internationally, and capitalizing on a strong pipeline of next-generation oncology products. These actions are critical for the company to move past recent reimbursement headwinds and achieve its financial targets.

Expanding GeneSight's reimbursement to more commercial payors

The primary near-term opportunity is to secure new coverage for the GeneSight pharmacogenomics (PGx) test to offset the significant revenue loss from UnitedHealthcare (UNH). The UNH discontinuation of coverage for multi-gene PGx testing became effective in the first quarter of 2025, creating a substantial financial headwind of approximately $45 million in annualized revenue compared to 2024.

Despite this setback, the underlying demand for GeneSight remains strong. Test volume for GeneSight actually grew by 8% year-over-year in the third quarter of 2025, a clear sign that clinicians see the value, even if reimbursement is challenging. The company's focus must be on leveraging this clinical demand to finalize contracts with other major commercial payors. Every new contract that covers GeneSight for major depressive disorder (MDD) or anxiety represents a direct path to recovering the lost revenue base, quickly turning a 2025 weakness into a 2026 strength.

One new major payor can change the whole financial picture.

International market expansion, especially for women's health products

Myriad Genetics has a clear opportunity to grow its Women's Health portfolio-MyRisk, Foresight, Prequel, and SneakPeek-by focusing on key international markets. The company has strategically realigned its international operations to concentrate direct sales efforts on high-growth areas like Germany, France, and Japan. This focus is a smart move following the divestiture of the international EndoPredict business in August 2024, which streamlines the organization.

The Prenatal testing segment in the US is already showing strong momentum, with revenue growing 7% year-over-year in the second quarter of 2025 and 2% in the third quarter of 2025, driven by expanding payer coverage for products like the Foresight Expanded Carrier Screen. Translating this success-especially with the enhanced Foresight Universal Plus Panel and the Prequel Early Gestational Age test-into the focused international markets is the next logical step for growth. The Oncology business has already shown this is possible, with the BRACAnalysis CDx test seeing a 200% year-over-year increase in volume in Japan previously, setting a precedent for international success.

New product launches like Precise Tumor Profiling gaining traction

The Oncology pipeline is a significant opportunity, moving Myriad Genetics into the high-growth liquid biopsy and minimal residual disease (MRD) markets. The company is already seeing continuing traction with its Precise Tumor comprehensive genomic panel, a somatic test that examines over 500 genes to match patients with advanced solid tumors to appropriate therapy.

The real upside, however, comes from the new product pipeline:

  • Precise Liquid: A liquid biopsy therapy selection test, expected to commercially launch in 2026, offering comprehensive genomic profiling from a simple blood draw.
  • Precise MRD: A monitoring test to detect cancer recurrence earlier, which is already available for research use by pharmaceutical partners. Clinical data presented in May 2025 showed Myriad's ultra-sensitive Precise MRD test achieved 100% sensitivity at baseline in a Japanese study.
  • Strategic Collaboration: In September 2025, Myriad Genetics entered a strategic collaboration with SOPHiA GENETICS to develop a global liquid biopsy companion diagnostic (CDx) solution, a major boost to its Oncology offerings.

This shift to a comprehensive suite of oncology tests-from diagnosis (Precise Tumor) to therapy selection (Precise Liquid) and monitoring (Precise MRD)-provides a clear path to market share gains in the lucrative cancer care continuum.

Achieving full-year adjusted EPS guidance of $0.15 to $0.25 for FY2025

While the company's most recent full-year 2025 adjusted EPS guidance is a narrow range of $(0.02) to $0.02 as of November 2025, achieving the high end of the initial guidance or even exceeding the prior year's performance remains a key opportunity. The company is focused on operational discipline and revenue growth to drive profitability. Full-year 2025 revenue is projected to be between $818.0 million and $828.0 million.

Here's the quick math: reaching the upper bound of the aspirational $0.15 to $0.25 range would represent a substantial beat over the current guidance, signaling a successful navigation of the GeneSight headwind and a strong ramp-up of new products. The company's focus on maintaining a high gross margin, which was 69.9% in Q3 2025, and disciplined cost management (adjusted operating expenses decreased year-over-year in Q3 2025) are the levers to pull for this EPS acceleration. The goal is to drive top-line growth faster than operating expenses, a defintely achievable goal with successful new payor coverage.

FY2025 Financial Guidance and Performance Drivers Value/Range Key Opportunity Driver
Full-Year 2025 Revenue Guidance $818.0 million to $828.0 million New product traction (Precise Tumor) and Women's Health expansion.
Full-Year 2025 Adjusted EPS Guidance (Most Recent) $(0.02) to $0.02 Exceeding this range requires securing a major new GeneSight payor.
Q3 2025 GeneSight Test Volume Growth (Year-over-Year) 8% Demonstrates strong underlying demand despite UNH coverage loss.
Q3 2025 Women's Health Prenatal Revenue Growth (Year-over-Year) 2% Replicating this growth internationally, especially in Germany, France, and Japan.
Q3 2025 Gross Margin 69.9% Maintaining this high margin while growing revenue will drive EPS.

Finance: Track GeneSight volume growth against revenue per test to forecast the impact of new payor contracts by the end of Q4 2025.

Myriad Genetics, Inc. (MYGN) - SWOT Analysis: Threats

Honestly, the biggest threat you face isn't a single event, but a sustained, multi-front war on price and coverage. The market has fundamentally changed from the days of patent protection, and every dollar of revenue is now hard-fought against aggressive, lower-cost rivals and relentless payor scrutiny.

Aggressive, lower-cost competition from labs like Invitae and Natera

The genetic testing landscape is now a commodity market in many respects, forcing you to compete on price, turnaround time, and clinical utility (the test's real-world value) against labs that have built their models on high-volume, low-cost testing. This is why Myriad Genetics' volume growth is consistently outpacing revenue growth in key segments. For instance, in the second quarter of 2025, hereditary cancer testing volume in Oncology grew 10% year-over-year, but the revenue for that same segment only grew 9% year-over-year.

Here's the quick math: when volume growth is higher than revenue growth, it means your average revenue per test is declining or stabilizing at a lower rate. That's the direct impact of competitors like Natera, which is consolidating its position, especially after acquiring reproductive health assets from Invitae in early 2024. Natera's women's health tests, for example, have self-pay options typically priced around $249 to $349, a clear challenge to maintaining premium pricing for your own tests like Foresight.

  • Volume growth outpaces revenue: clear sign of pricing pressure.
  • Competitors offer low self-pay options, pressuring average selling price.
  • Consolidation (Natera acquiring Invitae assets) creates stronger rivals.

Regulatory changes impacting clinical utility and coverage decisions

The most immediate and quantifiable threat in 2025 came directly from a major private payor. UnitedHealthcare (UNH) made a decision to discontinue coverage for certain multi-gene panel pharmacogenetic tests, including your GeneSight test, effective in the first quarter of 2025.

This single regulatory shift immediately hit your bottom line. Pharmacogenomics revenue fell by a significant 20% year-over-year in the first quarter of 2025 due to this reduced coverage. This kind of 'headwind' is why your full-year 2025 revenue guidance was initially adjusted downward, and even after a subsequent raise, the current full-year 2025 revenue guidance of $818 million to $828 million still reflects the need to overcome major payor policy changes. What this estimate hides is the administrative cost and time spent fighting to re-establish coverage. It's a defintely a constant battle.

Ongoing risk of payor audits and reimbursement rate cuts

The structural pressure on reimbursement is a persistent threat, especially from federal payors like Medicare, which often sets the tone for private insurers. The Centers for Medicare & Medicaid Services (CMS) finalized cuts for 2025 that affect the entire laboratory industry, including you.

Specifically, the 2025 Medicare Physician Fee Schedule (PFS) conversion factor was reduced from $33.29 in 2024 to $32.35 in 2025, a 2.83% decrease. More broadly, the statutory phase-in of payment reductions under the Clinical Laboratory Fee Schedule (CLFS) from private payor rate implementation continues, with an applicable 15% reduction applying for Calendar Years (CYs) 2025 through 2027. This is a multi-year, programmed reduction that you must budget for, regardless of your test volumes.

Reimbursement Pressure Point (CY 2025) Specific Financial Impact/Rate Duration
Medicare PFS Conversion Factor Cut Reduction of 2.83% (from $33.29 to $32.35) Effective January 1, 2025
CLFS Payment Reduction Phase-in 15% reduction from private payor rates CY 2025 through 2027
Major Private Payor Coverage Loss (GeneSight) Pharmacogenomics revenue fell 20% in Q1 2025 Effective Q1 2025

Patent expirations increasing generic test availability

The core threat here isn't a single, imminent patent expiration date in 2025, but the permanent, post-monopoly reality established by the 2013 Supreme Court ruling that invalidated patents on isolated human genes like BRCA1 and BRCA2. This ruling permanently opened the door for any lab to offer multi-gene hereditary cancer panels, which is the definition of generic test availability in this industry.

While you continue to differentiate with proprietary tools like RiskScore and focus on high-value new products, the lack of a patent shield on your core hereditary cancer testing franchise means you are in a constant battle against low-cost, multi-gene panels. This forces significant and ongoing investment in clinical evidence and service differentiation to justify your price point over the competition. To be fair, you are working to build new patent protection around next-generation products, with the U.S. Patent and Trademark Office granting two new patents in February 2025 related to your Precise Molecular Residual Disease (MRD) assay. This shows the shift: the threat is the past loss of patent exclusivity, and the action is the race to patent the future of precision medicine.


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