Castle Biosciences Announces New York State Department of Health Approval of its AdvanceAD-Tx™ Test

Rhea-AI Summary

Castle Biosciences (Nasdaq: CSTL) received assay approval from the New York State Department of Health (NYSDOH) for its AdvanceAD-Tx™ gene expression profile test, a non-invasive assay designed to guide systemic therapy selection in patients aged 12 and older with moderate-to-severe atopic dermatitis (AD).

According to Castle Biosciences, AdvanceAD-Tx classifies patients into either a JAK Inhibitor Responder Profile or a Th2 Molecular Profile using a simple skin sample, providing molecular insight to support treatment choice. With this decision, Castle now has NYSDOH approval for all tests in its dermatology and ophthalmology portfolios, its TissueCypher test in gastroenterology, and its clinical laboratories in Phoenix and Pittsburgh.

Positive

• NYSDOH assay approval for AdvanceAD-Tx test for moderate-to-severe AD
• Non-invasive molecular test classifies patients into JAK inhibitor or Th2 profiles
• Expanded regulatory footprint with New York approval across dermatology and ophthalmology portfolios
• NYSDOH approval also covers TissueCypher test and labs in Phoenix and Pittsburgh

Negative

• None.

News Market Reaction – CSTL

+3.89%

+3.89% Session close to close

In the Jul 15 session, CSTL gained 3.89%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Set against a backdrop of Net Selling by insiders over the last 90 days and relatively low short pos...

Analysis

Set against a backdrop of Net Selling by insiders over the last 90 days and relatively low short positioning per platform data, this state-level test approval mainly adds to Castle’s execution story; investors may watch future utilization data and follow-on commercial metrics.

Key Figures

Eligible patient age: 12 years and older AD adult prevalence: 16.5 million adults AD pediatric prevalence: 9.6 million children +1 more

4 metrics

Eligible patient age 12 years and older AdvanceAD-Tx systemic therapy selection test

AD adult prevalence 16.5 million adults Atopic dermatitis in the United States

AD pediatric prevalence 9.6 million children Atopic dermatitis in the United States

Molecular profiles 2 profiles JAK Inhibitor Responder vs Th2 Molecular Profile in AdvanceAD-Tx

Historical Context

5 past events · Latest: Jul 09 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 09	Earnings call scheduling	Neutral	+3.9%	Announcement of timing for Q2 2026 results release and webcast.
Jun 25	Clinical study data	Positive	+6.1%	DecisionDx-Melanoma i31-SLNB outperformed MIA nomogram in DECIDE study.
Jun 23	Leadership recognition	Positive	+0.8%	CFO named 2026 CFO Awards honoree by Houston Business Journal.
Jun 16	Test adoption milestone	Positive	-1.0%	TissueCypher Barrett's Esophagus Test surpassed 100,000 clinical orders.
May 13	Conference presentation	Neutral	-2.6%	Planned company overview at 2026 Jefferies Global Healthcare Conference.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news has produced mixed reactions, with strong clinical data sometimes rewarded and certain commercial milestones seeing negative follow-through.

Key Terms

atopic dermatitis, gene expression profile, t helper type 2 (th2), janus kinase (jak) inhibitor, +1 more

5 terms

atopic dermatitis medical

"patients with moderate-to-severe atopic dermatitis"

A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.

gene expression profile medical

"AdvanceAD-Tx is a non-invasive gene expression profile test"

A gene expression profile is a snapshot of which genes in a cell or tissue are switched on and how strongly they are producing their products, like a theater marquee showing which plays are running and how popular each is. For investors, these profiles matter because they can indicate whether a drug or diagnostic is likely to work, reveal which patient groups will benefit, and reduce development time and risk—factors that influence a biotech company’s value and commercial prospects.

t helper type 2 (th2) medical

"including T helper type 2 (Th2)-targeted biologics and Janus kinase (JAK)"

T helper type 2 (Th2) are a subgroup of white blood cells that direct parts of the immune system by signaling other cells to make certain antibodies and drive allergy-related inflammation. They matter to investors because drugs, vaccines, or diagnostics that raise or lower Th2 activity can change treatment outcomes for allergies, asthma and related conditions, so clinical or regulatory news tied to Th2 biology can materially affect companies working in immunology — think of Th2 as a thermostat that controls one immune circuit.

janus kinase (jak) inhibitor medical

"including T helper type 2 (Th2)-targeted biologics and Janus kinase (JAK) inhibitor therapies"

A janus kinase (JAK) inhibitor is a type of medicine that blocks a family of enzymes inside cells that act like message relays for the immune system and cell growth. By interrupting those internal “phone lines,” these drugs can reduce harmful inflammation or slow certain cancers; for investors, JAK inhibitors matter because clinical trial results, regulatory approvals, safety signals, and patent position directly affect market potential and company valuation.

laboratory-developed tests regulatory

"the only U.S. jurisdiction that conducts a formal review of laboratory-developed tests"

Laboratory-developed tests are medical tests that a single clinical laboratory designs, builds and runs internally rather than buying from outside manufacturers. Think of them as an in-house recipe a lab creates to detect a disease or measure a biomarker; they matter to investors because they can drive revenue, offer faster product development and carry distinct regulatory and reimbursement risks that affect a healthcare company's financial outlook.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Approval expands access to Castle's precision medicine test designed to guide systemic treatment decision making in patients with moderate-to-severe atopic dermatitis

FRIENDSWOOD, Texas, July 14, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its AdvanceAD-Tx test. AdvanceAD-Tx is a non-invasive gene expression profile test designed to guide systemic therapy selection for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).

"We are proud to announce the final approval of our AdvanceAD-Tx test by the NYSDOH's Clinical Laboratory Evaluation Program. This approval makes it easier than ever for patients in New York with moderate-to-severe AD to access a test which helps identify the class of systemic therapy to which they are most likely to respond based on the underlying biology of their disease," said Kristen Oelschlager, chief operating officer at Castle Biosciences. "New York State is the only U.S. jurisdiction that conducts a formal review of laboratory-developed tests before they can be offered to patients; this approval further demonstrates the level of quality and regulatory rigor we seek to achieve with each of our test offerings."

With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher® test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh.

"Too often, patients with AD spend months on therapies that do not adequately control their disease," said Matthew Goldberg, M.D., senior vice president, medical, at Castle Biosciences. "AdvanceAD-Tx was developed to provide clinicians with objective molecular insight that can help guide a more confident and personalized treatment decision from the start, with the goal of helping patients achieve meaningful relief from their symptoms sooner."

AD is a chronic inflammatory skin disease that affects approximately 16.5 million adults and 9.6 million children in the United States. Despite a rapidly expanding treatment landscape, including T helper type 2 (Th2)-targeted biologics and Janus kinase (JAK) inhibitor therapies, identifying the most appropriate systemic therapy for an individual patient remains a major clinical challenge. Patients frequently experience treatment switching and modification due to inadequate response, highlighting the need for molecular tools to guide therapy selection.

AdvanceAD-Tx analyzes a patient's individual disease biology from a simple, non-invasive skin sample to classify them into one of two molecular profiles — a JAK Inhibitor Responder Profile or a Th2 Molecular Profile — providing clinicians with objective molecular insight to help guide systemic treatment selection.

About AdvanceAD-Tx
AdvanceAD-Tx is a non-invasive gene expression profile (GEP) test designed to guide systemic treatment decisions for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). Using RNA expression data from lesional skin scraping samples—no biopsy required—the test evaluates 487 genes across 12 inflammatory and cutaneous biology pathways to reveal the underlying immune biology driving an individual patient's disease. Results classify patients into one of two molecular profiles: a Janus kinase (JAK) Inhibitor Responder Profile or a T helper 2 (Th2) Molecular Profile.

The prospective, clinical validation study showed that patients with a JAK Inhibitor Responder Profile given JAK inhibitor therapy experience significantly greater clinical benefit — including improved and faster skin clearance (EASI-90), greater likelihood of achieving no itch and remaining flare-free, and better quality of life by three months — compared to those treated with a Th2-targeted therapy.¹ AdvanceAD-Tx provides clinicians with objective, molecular-based insights to help personalize systemic treatment decisions and improve care for patients. Learn more at https://castlebiosciences.com/tests/therapy-guidance/advancead-tx/overview.

About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes.

We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Instagram, Facebook and X. 

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, Esopredict, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. These forward-looking statements include, but are not limited to, statements concerning: expanded access to diagnostic testing; and AdvanceAD-Tx's ability to (i) extend personalized, molecularly guided care into inflammatory skin disease, (ii) help clinicians select treatments that can improve patient outcomes and reduce unnecessary treatment cycling, (iii) transform how moderate-to-severe AD is managed, (iv) enable biology-informed treatment decisions and (v) help patients achieve meaningful relief from their symptoms. The words "believe," "can," "may" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and our subsequent Quarterly Reports on Form 10-Q, each as filed or to be filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

¹ Silverberg JI, Eichenfield LF, Armstrong AW, et al. The 487-gene expression profile test guides systemic therapy selection to improve outcomes for patients with atopic dermatitis: results from a prospective trial. J Am Acad Dermatol. 2026. doi:10.1016/j.jaad.2026.02.034

Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com

Media Contact:
Allison Marshall
amarshall@castlebiosciences.com

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SOURCE Castle Biosciences, Inc.

FAQ

What did New York State approve for Castle Biosciences (CSTL) on July 14, 2026?

New York State approved Castle Biosciences’ AdvanceAD-Tx assay on July 14, 2026. According to Castle Biosciences, the NYSDOH clearance allows the company to offer this atopic dermatitis gene expression test to eligible patients within New York.

What is Castle Biosciences’ AdvanceAD-Tx test for atopic dermatitis (CSTL)?

AdvanceAD-Tx is a non-invasive gene expression profile test for moderate-to-severe atopic dermatitis. According to Castle Biosciences, it analyzes skin samples to classify patients into JAK Inhibitor Responder or Th2 Molecular Profiles to help guide systemic treatment selection.

Who is eligible for the AdvanceAD-Tx atopic dermatitis test from Castle Biosciences (CSTL)?

AdvanceAD-Tx is intended for patients aged 12 years and older with moderate-to-severe atopic dermatitis. According to Castle Biosciences, the test is designed to support systemic therapy decision making in this specific patient population using molecular insights.

How does AdvanceAD-Tx guide treatment decisions for atopic dermatitis according to Castle Biosciences (CSTL)?

AdvanceAD-Tx guides treatment by classifying a patient’s disease biology into JAK inhibitor or Th2 profiles. According to Castle Biosciences, this objective molecular information can help clinicians select systemic therapies more confidently and potentially reduce ineffective treatment cycles.

What other Castle Biosciences (CSTL) tests have New York State approval?

According to Castle Biosciences, New York State has approved all tests in its dermatology and ophthalmology portfolios, its TissueCypher test in gastroenterology, and its clinical laboratories in Phoenix and Pittsburgh, alongside the newly approved AdvanceAD-Tx assay.

Why is New York State approval important for Castle Biosciences’ AdvanceAD-Tx test (CSTL)?

New York requires formal review of laboratory-developed tests before patient use, so approval expands access there. According to Castle Biosciences, NYSDOH clearance demonstrates regulatory rigor and enables patients in New York to access the AdvanceAD-Tx precision medicine test.