Castle Biosciences’ IDgenetix® Test Receives 2024 MedTech Breakthrough Award for “Best Overall Mental Health Solution”

This marks the fourth consecutive year that Castle has earned a MedTech Breakthrough Award for its innovative testing solutions

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been selected as the winner of the “Best Overall Mental Health Solution” award in the eighth annual MedTech Breakthrough Awards program for its IDgenetix® pharmacogenomic (PGx) test. The MedTech Breakthrough Awards honor excellence and recognize innovation, hard work and success in a range of health and medical technology categories, attracting thousands of nominations from over 18 countries across the world.

“Nearly half of all Americans will meet the criteria to be diagnosed with a mental health condition at some point during their life,”¹ said Derek Maetzold, president and chief executive officer of Castle Biosciences. “This stark reality underscores the critical need for advanced tests like IDgenetix that can improve medication management for those struggling with neuropsychiatric conditions.”

“By taking into account lifestyle factors and drug-drug interactions in addition to drug-gene interactions, IDgenetix provides invaluable information that may impact a patient’s response to medications,” said Steve Johansson, managing director, MedTech Breakthrough. “So many patients with major depressive disorder don’t achieve remission even after trying multiple medications. Others don't achieve remission until trying four or more medications, delaying critical relief for those struggling with the daily challenges of their conditions. IDgenetix is designed to arm clinicians with personalized health information to help guide medication selection and management decisions, so patients can potentially achieve remission from their neuropsychiatric condition faster.”

“May is Mental Health Month, and receiving this recognition now makes it even more meaningful, as we strive to improve mental health care through personalized PGx testing," continued Maetzold. “We are incredibly honored to have earned a fourth MedTech Breakthrough Award for our innovative tests designed to improve patient care.”

Observed each May, Mental Health Month was founded by Mental Health America (MHA) to promote awareness, provide vital resources and education, and advocate for the mental health and well-being of all people living in the United States. Castle is proud to be a platinum sponsor of MHA in 2024, which marks the 75th year since the organization launched Mental Health Week, which later evolved into Mental Health Month.

IDgenetix is Castle Biosciences' advanced precision medicine test that offers clinicians an objective way to choose or modify neuropsychiatric medication for their patients with mental health conditions. By combining pharmacogenomics (PGx) — the practice of analyzing a patient’s DNA for pharmacogenetic biomarkers that may influence response to medication — with drug-drug interactions and lifestyle factor data, IDgenetix can help facilitate a more informed approach to mental health care in patients suffering from 10 neuropsychiatric conditions. While currently available PGx tests include information on genetic variants that may affect the efficacy or side-effect profile of a prescribed medication, Castle believes IDgenetix offers more by also considering lifestyle factors and drug-drug interactions. Randomized controlled study data presented at Psych Congress 2023 showed that integrating drug-gene, drug-drug and lifestyle factors provides 75% more guided information compared to traditional drug-gene interactions alone.²

Castle has previously won three consecutive MedTech Breakthrough Awards: “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 gene expression profile (GEP) test, and “Best New Technology Solution — Oncology” in 2021 for its DecisionDx®-SCC and DiffDx®-Melanoma GEP tests.

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.

About Mental Health America

Mental Health America (MHA) is the nation's leading national nonprofit dedicated to the promotion of mental health, well-being and illness prevention. MHA’s work is informed, designed, and led by the lived experience of those most affected. Operating nationally and in communities across the country, MHA advocates for closing the mental health equity gap while increasing nationwide awareness and understanding through public education, direct services, tools and research. MHA’s annual State of Mental Health in America report is among the most widely respected health reports in the nation. Visit MHANational.org for more information.

About IDgenetix

IDgenetix is a pharmacogenomic (PGx) test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that observed clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. IDgenetix is currently reimbursed by Medicare for the following eight mental health conditions: major depressive disorder, schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

1. Mental Health America; https://mhanational.org/mentalhealthfacts; accessed 4/23/24
2. The Importance of Incorporating Drug-Drug Interactions and Lifestyle Factors in Pharmacogenomics-Guided Medication Management for Patients With Major Depressive Disorder in a Randomized Controlled Trial; https://castlebiosciences.com/Scientific%20Evidence/Files/MH_01_002%20Psych%20Congress%20Final%20Upload.pdf

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: the ability of IDgenetix to (i) improve medication management for those struggling with neuropsychiatric conditions; (ii) provide invaluable information that may impact a patient’s response to medications; (iii) arm clinicians with personalized health information to help guide medication selection and management decisions to help patients potentially achieve remission from their neuropsychiatric condition faster; and (iv) help facilitate a more informed approach to mental health care in patients suffering from 10 neuropsychiatric conditions. The words “can,” “would” 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 shown in this study, including with respect to the discussion of IDgenetix in this press release; actual application of our IDgenetix test 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, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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.

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