Castle Biosciences' AdvanceAD-Tx™ Test Receives 2026 MedTech Breakthrough Award for Genomics Innovation

Castle Biosciences (Nasdaq:CSTL) announced that its AdvanceAD-Tx test won the 2026 MedTech Breakthrough Genomics Innovation Award, the company’s fifth MedTech Breakthrough honor.

Rhea-AI Summary

Castle Biosciences (Nasdaq:CSTL) announced that its AdvanceAD-Tx test won the 2026 MedTech Breakthrough Genomics Innovation Award, the company’s fifth MedTech Breakthrough honor.

AdvanceAD-Tx is a clinically validated, non-invasive gene expression profile test guiding systemic treatment selection for patients 12+ with moderate-to-severe atopic dermatitis, supported by prospective multi-center data on skin clearance and symptom relief.

Positive

• Prospective study: JAK Inhibitor Responder Profile patients were 5.5x likelier to achieve near-clear skin (EASI-90) when treated in alignment with AdvanceAD-Tx results
• Aligned JAK Inhibitor Responder Profile patients reached near-clear skin 3.8x faster than those treated with a Th2-targeted therapy
• AdvanceAD-Tx uses a non-invasive lesional skin scraping, avoiding the need for a biopsy in moderate-to-severe AD patients
• AdvanceAD-Tx provides objective molecular guidance at the therapy-class level, potentially reducing unnecessary systemic treatment cycling
• This is Castle’s fifth MedTech Breakthrough Award, adding third-party recognition for its testing portfolio

Negative

• None.

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News Market Reaction – CSTL

On May 12, the day this news came out, CSTL closed 2.15% below the previous close.

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Key Figures

MedTech Breakthrough awards: 5 awards Program edition: 10th annual Eligible patient age: 12 and older +5 more

MedTech Breakthrough awards

5 awards

Total MedTech Breakthrough Awards Castle has earned

Program edition

10th annual

10th annual MedTech Breakthrough Awards program

Eligible patient age

12 and older

Patients with moderate-to-severe atopic dermatitis for AdvanceAD-Tx

Genes measured

487 genes

AdvanceAD-Tx gene expression profile test

Pathways analyzed

12 pathways

Skin and inflammatory pathways linked to atopic dermatitis

Likelihood of EASI-90

5.5 times more likely

JAK responder patients treated per AdvanceAD-Tx profile

Time to response

3.8 times faster

Time to near-clear skin vs Th2-targeted therapy

Countries represented

more than 20

Nominations for this year’s MedTech Breakthrough Awards

Historical Context

5 past events · Latest: May 06

5 events

1. May 06

   Q1 2026 earnings

   24h Move

   -22.3%

   Reported Q1 results, narrowed net loss and raised full-year 2026 revenue guidance.

2. May 05

   Advocacy initiatives

   24h Move

   -3.6%

   Announced broad skin cancer awareness efforts with screenings and advocacy partnerships.

3. May 04

   Clinical data update

   24h Move

   +2.9%

   Presented Mayo Clinic data showing TissueCypher improves risk stratification in Barrett’s esophagus.

4. Apr 21

   Upcoming data

   24h Move

   -2.3%

   Planned presentations of DecisionDx-Melanoma data highlighting recurrence risk identification.

5. Apr 15

   Earnings date notice

   24h Move

   +1.0%

   Announced timing of Q1 2026 earnings release and webcast for investors.

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

Key Terms

gene expression profile, atopic dermatitis, janus kinase (jak) inhibitor, t-helper 2 (th2) molecular profile, +3 more

7 terms

gene expression profile medical

"AdvanceAD-Tx is Castle's clinically validated gene expression profile (GEP) 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.

atopic dermatitis medical

"...treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD)."

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.

janus kinase (jak) inhibitor medical

"...two results: a Janus kinase (JAK) Inhibitor Responder Profile or a T-helper 2 (Th2) Molecular Profile..."

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.

t-helper 2 (th2) molecular profile medical

"...a Janus kinase (JAK) Inhibitor Responder Profile or a T-helper 2 (Th2) Molecular Profile..."

A T-helper 2 (Th2) molecular profile is a pattern of genes and proteins that shows a person’s immune system is skewed toward Th2-type activity, the pathway often involved in allergies and certain inflammatory conditions. Investors should care because this profile acts like a biological fingerprint used to predict which patients are likely to respond to specific drugs, shape clinical trial design, and affect the size and pricing of the addressable market for therapies and diagnostics.

easi-90 medical

"...were 5.5 times more likely to achieve near-clear skin (EASI-90) and reached that response..."

A clinical-trial endpoint that measures a 90% improvement in a patient’s eczema signs and affected skin area compared with their baseline score. It’s a high bar for treatment effectiveness—like cutting nine out of ten problem spots—and matters to investors because achieving EASI-90 can signal a therapy is substantially better than existing options, boosting chances of regulatory approval, market adoption, and commercial value.

multi-center validation study medical

"In a prospective, multi-center validation study, patients with a JAK Inhibitor Responder Profile..."

A multi-center validation study is a research test conducted at several independent hospitals, clinics, or labs to confirm that a medical test, treatment, or device works reliably across different places and patient groups. For investors, results from such studies carry more weight because they reduce the chance that positive findings were a fluke, support regulatory approval and wider market adoption, and therefore lower development and commercialization risk.

systemic therapy medical

"...actionable guidance for systemic therapy class selection in AD."

Treatments that travel through the bloodstream or throughout the body to reach disease sites rather than targeting a single spot—think of a citywide water main delivering resources rather than a local hose. They include drugs given orally, by injection, or infusion and are commonly used for cancers, infections, and autoimmune diseases. Investors care because systemic therapies often address large patient populations, drive long-term drug sales, carry regulatory and safety risks, and shape competitive positioning and pricing in healthcare markets.

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

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This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions

FRIENDSWOOD, Texas, May 12, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its AdvanceAD-Tx test has been selected as the winner of the "Genomics Innovation Award" in the 10th annual MedTech Breakthrough Awards program, which recognizes companies driving meaningful progress and improving patient care across the global health and medical technology industry. AdvanceAD-Tx is Castle's clinically validated gene expression profile (GEP) test designed to guide systemic treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD).

"AdvanceAD-Tx builds on our expertise in dermatologic gene expression profiling, extending personalized, molecularly guided care into inflammatory skin disease for the first time," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "AdvanceAD-Tx provides an objective tool designed to guide systemic therapy class selection for patients suffering from moderate-to-severe AD, helping clinicians more confidently select systemic treatments that can improve patient outcomes."

Using a novel, non-invasive lesional skin scraping — no biopsy required — the AdvanceAD-Tx test measures the expression of 487 genes across 12 skin and inflammatory pathways linked to AD. Advanced analytics translate this biology into two results: a Janus kinase (JAK) Inhibitor Responder Profile or a T-helper 2 (Th2) Molecular Profile, providing clear, actionable guidance at the therapy-class level. AdvanceAD-Tx allows clinicians to match therapy to an individual's immune profile using objective molecular testing, personalizing treatment for their patients and reducing unnecessary treatment cycling.

In a prospective, multi-center validation study, patients with a JAK Inhibitor Responder Profile who were treated in alignment with their AdvanceAD-Tx test results were 5.5 times more likely to achieve near-clear skin (EASI-90) and reached that response 3.8 times faster than those treated with a Th2-targeted therapy.¹ These patients also experienced significantly greater itch relief, fewer flares and improvements in quality of life — without dose escalation.

"AdvanceAD-Tx translates disease biology into actionable guidance for systemic therapy class selection in AD. AD affects millions of patients and is biologically heterogeneous, yet treatment selection has traditionally relied on clinical assessment alone. As a result, most patients cycle through systemic therapies that don't adequately address the immune pathways driving the disease," said Steve Johansson, managing director, MedTech Breakthrough. "By providing objective insight to support systemic treatment selection, AdvanceAD-Tx transforms how moderate-to-severe AD is managed, enabling more confident, biology-informed treatment decisions that can improve patient outcomes, patient experience and healthcare value."

Castle has won previous MedTech Breakthrough Awards for its innovative tests, including: "Best Use of Artificial Intelligence in Healthcare" in 2023 for its TissueCypher® Barrett's Esophagus test, "Best New Technology Solution — Dermatology" in 2022 for its DecisionDx®-Melanoma GEP test, and "Best New Technology Solution — Oncology" in 2021 for its DecisionDx®-SCC test.

This year's program drew a record-breaking number of nominations from leading companies and startups across more than 20 countries, reflecting the growing global impact and momentum of the digital healthcare industry.

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: Janus Kinase (JAK) Inhibitor Responder Profile or T helper 2 (Th2) Molecular Profile.

The prospective, clinical validation study showed that the test identifies a subset of patients with a JAK Inhibitor Responder Profile who experience significantly greater clinical benefit — including improved and faster skin clearance (EASI-90), reduced itch, fewer flares and better quality of life by three months — when treated with a JAK inhibitor therapy compared to those treated with a Th2-targeted therapy. 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.

About MedTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.

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: 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, and (iv) enable biology-informed treatment decisions. 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, Bagel J, Lockshin B, Boh E, Koo J, Farberg AS, Goldberg MS, Quick AP, Lebwohl MG,] The 487-gene expression profile test guides systemic therapy selection to improve outcomes for patients with atopic dermatitis: Results from a prospective, multi-center trial. J of Skin. 2025;9(6):s621. doi:10.25251/g9hnsn32

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SOURCE Castle Biosciences, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Castle Biosciences’ AdvanceAD-Tx test and who is it for (CSTL)?

AdvanceAD-Tx is a clinically validated gene expression profile test for patients 12 and older with moderate-to-severe atopic dermatitis. According to Castle Biosciences, it guides systemic therapy class selection using molecular insights from lesional skin scraping.

Why did AdvanceAD-Tx from Castle Biosciences (CSTL) win the 2026 MedTech Breakthrough Genomics Innovation Award?

AdvanceAD-Tx received the 2026 Genomics Innovation Award for its role in guiding systemic treatment decisions in atopic dermatitis. According to Castle Biosciences, the test translates expression of 487 genes into actionable JAK Inhibitor or Th2 molecular profiles.

How does the AdvanceAD-Tx test by Castle Biosciences (CSTL) work in atopic dermatitis?

AdvanceAD-Tx uses a non-invasive lesional skin scraping to measure 487 genes across 12 skin and inflammatory pathways. According to Castle Biosciences, advanced analytics classify patients into JAK Inhibitor Responder or Th2 Molecular Profiles to support therapy-class selection.

What clinical outcomes are associated with AdvanceAD-Tx-guided treatment in Castle Biosciences’ data?

In a prospective multi-center study, patients with a JAK Inhibitor Responder Profile treated accordingly were 5.5 times more likely to reach EASI-90. According to Castle Biosciences, they also reached near-clear skin 3.8 times faster with better itch, flare, and quality-of-life outcomes.

What makes AdvanceAD-Tx important for managing moderate-to-severe atopic dermatitis (CSTL)?

AdvanceAD-Tx offers objective molecular guidance for systemic therapy class selection in biologically heterogeneous atopic dermatitis. According to Castle Biosciences, it helps reduce empirical treatment cycling by matching therapies to individual immune profiles, potentially improving outcomes and healthcare value.

How many MedTech Breakthrough Awards has Castle Biosciences (CSTL) received and for which tests?

Castle Biosciences has earned five MedTech Breakthrough Awards, including the 2026 Genomics Innovation Award for AdvanceAD-Tx. According to the company, previous awards honored TissueCypher Barrett’s Esophagus, DecisionDx-Melanoma, and DecisionDx-SCC across AI, dermatology, and oncology categories.