Castle Biosciences, Inc. - CSTL STOCK NEWS

Castle Biosciences (CSTL) announced preliminary unaudited results for Q4 and full-year 2024, expecting to meet or exceed the top end of its guided revenue range of $320-330 million, representing at least 50% growth over 2023. The company delivered 96,071 total test reports in 2024, up 36% from 2023.

Q4 2024 saw 24,071 test reports delivered, a 19% increase year-over-year. Notable growth was seen in TissueCypher Barrett's Esophagus tests (+94%) and DecisionDx-SCC (+22%), while MyPath Melanoma and IDgenetix tests decreased by 14% and 5% respectively.

The company's year-end 2024 financial position shows approximately $293 million in combined cash, cash equivalents, and marketable investment securities. However, Novitas, a Medicare Administrative Contractor, finalized a non-coverage determination for the DecisionDx-SCC test on January 9, 2025.

Castle Biosciences (CSTL) has received assay approval from the New York State Department of Health for its TissueCypher Barrett's Esophagus test. This approval marks the completion of New York state approval for all of Castle's tests across its dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh.

TissueCypher is the first AI-driven precision medicine test designed to predict progression risk from Barrett's esophagus (BE) to esophageal cancer. The test analyzes cancer-associated biomarkers and spatial biology features to identify molecular signatures of BE progression before visible tissue changes occur. This tool helps clinicians risk-stratify the estimated 5% of U.S. adults with BE, enabling risk-aligned surveillance or earlier interventions to prevent cancer development.

Castle Biosciences (CSTL) provided an update on its pipeline test for moderate-to-severe atopic dermatitis (AD) patients seeking systemic treatment. Preliminary data shows the test may identify patients likely to achieve a super response (90% or greater reduction in EASI score) to targeted therapies within three months.

The company has enrolled over 1,100 patients across 39 clinical study sites for its development and validation study. With an estimated 6 million U.S. patients diagnosed with moderate-to-severe AD annually, and approximately 760,000 seeking systemic treatment, the test aims to improve the current 'trial-and-error' approach, where 25% of patients discontinue initial therapy and 50% show persistent disease burden.

Assuming successful validation, Castle expects to launch the test by the end of 2025.

Castle Biosciences (CSTL) announced that its Board of Directors' Compensation Committee has granted restricted stock units (RSUs) to 135 employees, covering 173,542 shares of common stock. The grants were made under the Company's 2022 Inducement Plan, complying with Nasdaq Listing Rule 5635(c)(4). The RSUs have a four-year vesting schedule, with 25% vesting after the first year and the remaining balance vesting in three equal annual installments, contingent on continued employment.

Castle Biosciences (CSTL) announced the publication of an independent meta-analysis in Cancers evaluating their DecisionDx-Melanoma test for predicting melanoma patient outcomes. The analysis, reviewing 13 peer-reviewed studies, confirms the test's effectiveness in risk stratification for cutaneous melanoma (CM) patients.

The study revealed five-year melanoma-specific survival rates of 99.8% for lowest risk (Class 1A), 97.6% for increased risk (Class 1B/2A), and 83.4% for highest risk (Class 2B) patients. The test demonstrated consistent ability to stratify patients into risk groups with significantly different outcomes, supporting its use alongside current staging systems for enhanced patient care management.

Castle Biosciences (Nasdaq: CSTL), a healthcare company specializing in innovative diagnostic tests, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's executive management will deliver a corporate overview on Wednesday, Dec. 4, 2024, at 10:50 a.m. Eastern time.

A live audio webcast of the presentation will be accessible through Castle Biosciences' investor relations website. Additionally, a replay of the presentation will be made available after the live broadcast concludes.

Castle Biosciences (CSTL) has been named a Houston Top Workplace for 2024 by the Houston Chronicle, marking its fourth consecutive year receiving this recognition. The company also earned three additional Culture Excellence awards for Employee Appreciation, Employee Well-Being, and Professional Development.

The recognition is based on anonymous employee feedback collected through Energage's third-party survey, which measures various aspects of employee experience including feeling respected, supported, and empowered. Castle has accumulated a total of 12 Top Workplaces awards for 2024, including regional awards for Houston and Arizona, and ten national awards. The company ranked 28th among 370 companies in the Top Workplaces USA category and fourth out of 95 firms in the Healthcare Industry category.

Castle Biosciences (Nasdaq: CSTL) will present new data on its DecisionDx-Melanoma and MyPath Melanoma tests at the American Society of Dermatopathology 61st Annual Meeting in Chicago, November 7-10. The presentations will showcase the clinical performance of these tests in risk-stratification for patients with confirmed or suspected melanoma.

Two posters will be presented by Dr. Etan Marks during a poster defense session on November 9. The first poster focuses on the integrated 31-gene expression profile test for melanoma recurrence risk stratification, while the second discusses statistical methods for assessing the diagnostic performance of the 23-gene expression profile test for cutaneous melanocytic neoplasms.

Castle Biosciences, a precision medicine company, announced a milestone for its TissueCypher Barrett’s Esophagus test, surpassing 25,000 test reports delivered since acquiring the test in late 2021. TissueCypher predicts the risk of progression from Barrett’s esophagus (BE) to esophageal cancer. BE is the only known precursor to esophageal adenocarcinoma, a rapidly increasing cancer in the U.S. with a five-year survival rate of 22%. TissueCypher, supported by 14 peer-reviewed studies, outperforms traditional pathology diagnoses, providing personalized risk scores and actionable insights. This test can help clinicians make informed decisions, potentially preventing esophageal cancer through tailored surveillance and intervention strategies.