Castle Biosciences' AdvanceAD-Tx™ Test Receives 2026 MedTech Breakthrough Award for Genomics Innovation
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.
AI-generated analysis. Not financial advice.
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.
Key Figures
Market Reality Check
Peers on Argus
CSTL fell 3.98% while close diagnostics peers were mixed, with FLGT up slightly and CDNA, MYGN, PSNL and NEO down modestly, pointing to a stock-specific move rather than a broad sector shift.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 06 | Q1 2026 earnings | Positive | -22.3% | Reported Q1 results, narrowed net loss and raised full-year 2026 revenue guidance. |
| May 05 | Advocacy initiatives | Positive | -3.6% | Announced broad skin cancer awareness efforts with screenings and advocacy partnerships. |
| May 04 | Clinical data update | Positive | +2.9% | Presented Mayo Clinic data showing TissueCypher improves risk stratification in Barrett’s esophagus. |
| Apr 21 | Upcoming data | Positive | -2.3% | Planned presentations of DecisionDx-Melanoma data highlighting recurrence risk identification. |
| Apr 15 | Earnings date notice | Neutral | +1.0% | Announced timing of Q1 2026 earnings release and webcast for investors. |
Recent positive or neutral news, including raised guidance and clinical data, has often been met with flat-to-negative price reactions.
Over the last month, Castle Biosciences reported Q1 2026 revenue of $83.7 million and raised 2026 guidance to $345–355 million, yet the stock fell 22.26% after earnings. Multiple clinically oriented announcements on TissueCypher and DecisionDx-Melanoma, plus advocacy initiatives around skin cancer awareness, saw mixed to negative reactions, with only the DDW 2026 TissueCypher data generating a modest 2.86% gain. Today’s AdvanceAD-Tx award extends the company’s dermatology and inflammatory disease positioning within this backdrop of cautious trading.
Market Pulse Summary
This announcement showcases continued recognition of Castle’s genomic testing capabilities, with AdvanceAD-Tx winning a 2026 MedTech Breakthrough award and demonstrating strong validation data, including 5.5x higher EASI-90 achievement. It adds to recent milestones such as Q1 2026 revenue of $83.7 million and raised guidance to $345–355 million. In assessing impact, investors might track adoption of AdvanceAD-Tx alongside performance of core tests like DecisionDx-Melanoma and TissueCypher and monitor how future earnings reflect growth in inflammatory skin disease testing.
Key Terms
gene expression profile medical
atopic dermatitis medical
janus kinase (jak) inhibitor medical
t-helper 2 (th2) molecular profile medical
easi-90 medical
systemic therapy medical
AI-generated analysis. Not financial advice.
This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions
"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
View original content to download multimedia:https://www.prnewswire.com/news-releases/castle-biosciences-advancead-tx-test-receives-2026-medtech-breakthrough-award-for-genomics-innovation-302768633.html
SOURCE Castle Biosciences, Inc.