Veracyte Secures Medicare Reimbursement for Prosigna Breast Risk of Recurrence Test

Coverage establishes a reimbursement path for eligible Medicare patients following Prosigna’s June 2026 U.S. launch.

Rhea-AI Summary

Veracyte (Nasdaq: VCYT) secured Medicare coverage for its Prosigna Breast Risk of Recurrence test, effective August 19, 2026.

Coverage through Palmetto GBA’s MolDX program applies to postmenopausal women with early-stage estrogen receptor positive breast cancer who meet Medicare criteria, including stage I or II disease with 0-3 positive lymph nodes. Following the test’s June 2026 U.S. launch, Veracyte expects reimbursement to support broader adoption. Prosigna estimates the risk of breast cancer recurring over 10 years. The independent phase III OPTIMA trial demonstrated that Prosigna-guided treatment could spare chemotherapy for more than two-thirds of patients with clinically high-risk breast cancer without compromising outcomes.

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0 major · 1 point

How the balance works

Positive

• Moderate pointMedicare coverage effective August 19, 2026, establishes a reimbursement path for eligible Prosigna patients.
• Moderate pointOPTIMA phase III trial showed Prosigna-guided treatment could spare chemotherapy for more than two-thirds of clinically high-risk patients without compromising outcomes.
• Minor pointVeracyte Access Program offers financial assistance or tailored payment plans for eligible uninsured and underinsured patients.

Negative

• Minor pointCoverage eligibility is limited to qualifying postmenopausal women with early-stage estrogen receptor positive breast cancer meeting Medicare criteria.

Key Figures

Coverage effective date: August 19, 2026 Eligibility criteria: Stage I or II; 0-3 positive lymph nodes Patients potentially spared chemotherapy: More than two-thirds +1 more

Coverage effective date

August 19, 2026

Medicare coverage for eligible patients

Eligibility criteria

Stage I or II; 0-3 positive lymph nodes

Applicable Medicare criteria for eligible patients

Patients potentially spared chemotherapy

More than two-thirds

Clinically high-risk breast cancer patients in the OPTIMA phase III trial; without compromising outcomes

Recurrence risk horizon

10 years

Period over which Prosigna estimates breast cancer recurrence risk

Key Terms

estrogen receptor positive, phase iii, laboratory-developed test, clia-certified

4 terms

estrogen receptor positive medical

"early-stage estrogen receptor positive (ER+) breast cancer"

A tumor labeled "estrogen receptor positive" means the cancer cells carry proteins that act like locks for the hormone estrogen; when estrogen fits the lock it can fuel tumor growth. For investors this matters because ER-positive tumors usually respond to hormone-blocking medicines and are treated differently than other cancers, so the ER status shapes which drugs are likely to succeed, how trials are designed, and the commercial outlook for therapies.

phase iii medical

"The independent, randomized phase III OPTIMA trial"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

laboratory-developed test regulatory

"Prosigna is available as a laboratory-developed test"

A laboratory-developed test is a diagnostic test that a single clinical laboratory designs, builds and uses in its own facility rather than buying from an outside manufacturer; think of it as a custom recipe made and run in-house for diagnosing disease. Investors care because these tests can be quicker to bring to market and create a revenue stream for labs, but they also carry regulatory and quality-risk differences that can affect demand, reimbursement and legal exposure.

clia-certified regulatory

"Veracyte’s CLIA-certified laboratory in San Diego"

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

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Milestone supports broader U.S. adoption of Prosigna and expands access for eligible patients with early-stage breast cancer

SOUTH SAN FRANCISCO, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Prosigna® Breast Risk of Recurrence (ROR) test has received coverage for its Technical Assessment submission through Palmetto GBA’s MolDX program. The decision creates a reimbursement path for eligible patients with early-stage breast cancer to receive critical genomic information to help guide their treatment.

Following Prosigna’s June 2026 U.S. launch, this milestone establishes a reimbursement foundation to support broader adoption of the test. Coverage is effective as of August 19, 2026, and applies to postmenopausal women with early-stage estrogen receptor positive (ER+) breast cancer who meet the applicable Medicare criteria, including stage I or II disease with 0-3 positive lymph nodes.¹

“We are pleased that Medicare has taken this significant step to ensure access to Prosigna for physicians and their breast cancer patients to support personalized treatment decisions,” said Marc Stapley, Veracyte's chief executive officer. “Securing Medicare reimbursement is a key step in establishing broad coverage for Prosigna. This milestone will help more patients with early-stage breast cancer, and their oncologists, make confident decisions about their treatment, including whether chemotherapy will truly benefit them.”

Prosigna analyzes the biology of a patient’s tumor to estimate the risk that breast cancer will recur over 10 years. By combining molecular information with clinical and pathological factors, the test helps oncologists tailor treatment to the individual patient and weigh the potential benefit of chemotherapy against its short- and long-term effects.

The independent, randomized phase III OPTIMA trial, led by University College London and presented at ASCO 2026, demonstrated that for more than two-thirds of patients with clinically high-risk breast cancer, Prosigna-guided treatment could spare them chemotherapy without compromising outcomes.²

Prosigna is available as a laboratory-developed test through Veracyte’s CLIA-certified laboratory in San Diego. The Veracyte Access Program offers financial assistance or tailored payment plans for eligible uninsured and underinsured patients. For clinical resources and ordering information, visit www.veracyte.com/prosigna.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company with a vision to transform cancer care for patients around the world. The company’s molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and AI, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma® Genomic Sequencing Classifier test, Decipher® Bladder Genomic Classifier test, Decipher® Prostate Genomic Classifier test, Prosigna® Breast Risk of Recurrence test, and the TrueMRD™ Monitoring Test for MIBC. For more information, visit Veracyte’s website or follow the company on LinkedIn or X (Twitter).

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding the potential clinical utility, impact, and benefits of Veracyte’s Prosigna® Breast Risk of Recurrence (ROR) test; the ability of the Prosigna test to help guide treatment decisions, including whether chemotherapy may benefit a patient; the extent to which the results of the OPTIMA trial may support treatment decisions; the potential for reimbursement of the Prosigna test through Medicare to expand access to the Prosigna test for eligible patients; the potential for broader adoption of the Prosigna test and broader coverage of the Prosigna test across patient populations; and the availability of financial assistance programs and patient access to the Prosigna test. Forward-looking statements can be identified by words such as “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” “ultimately,” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from our predictions. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 26, 2026, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or the reasons why actual results might differ, whether as a result of new information, future events, or otherwise. 

References:

1. Centers for Medicare & Medicaid Services. MolDX Breast Cancer Assay Prosigna. Local Coverage Determination L36125. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36125
2. Stein RC, Makris A, Macpherson IR, et al. First results from the OPTIMA phase III randomized non-inferiority trial of test-directed chemotherapy in patients with high clinical risk ER-positive HER2-negative early breast cancer. J Clin Oncol. 2026;44(16_suppl):500. doi:10.1200/JCO.2026.44.16_suppl.500.

Investors:
Kelly Gura
investors@veracyte.com

Media:
Molly Cornbleet
media@veracyte.com
+1 858-742-1258

FAQ

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Who qualifies for Medicare coverage of Veracyte’s Prosigna test?

Coverage applies to postmenopausal women with early-stage estrogen receptor positive breast cancer who meet applicable Medicare criteria, including stage I or II disease with 0-3 positive lymph nodes. Coverage is effective August 19, 2026, through Palmetto GBA’s MolDX program.

Does Veracyte offer financial assistance for Prosigna testing?

The Veracyte Access Program offers financial assistance or tailored payment plans for eligible uninsured and underinsured patients.