News | August 24, 2021

Castle Biosciences Awarded U.S. Federal Supply Schedule Contract For DecisionDx-Melanoma

FRIENDSWOOD, TEXAS--(BUSINESS WIRE)--

Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, today announced that it has been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration (VHA) for its DecisionDx®-Melanoma gene expression profile test.

The VHA is a component of and implements the healthcare program for U.S. veterans through the U.S. Department of Veterans Affairs (VA). The contract became effective on Aug. 15, 2021, and provides greater access to DecisionDx®-Melanoma for veterans being treated through the VHA, the largest integrated health care system in the U.S., as well as active-duty service members and their families seeking medical treatment through the Military Health System (MHS).

“At Castle, we are committed to improving the lives of patients with skin cancer,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We believe that adding the personalized genomic information provided by our DecisionDx-Melanoma test to traditional clinical and pathology factors can help clinicians make improved treatment decisions for their patients. This contract provides veterans and active-duty service members treated in VA and MHS medical centers greater access to our test, allowing them to incorporate DecisionDx-Melanoma into their management plans.”

Melanoma is the most frequently diagnosed and most deadly form of skin cancer, according to the American Cancer Society. Additionally, according to a 2017 study in the Journal of the American Academy of Dermatology(JAAD) titled “Skin cancer in the military: A systematic review of melanoma and nonmelanoma skin cancer incidence, prevention, and screening among active duty and veteran personnel,” active-duty military personnel and veterans are at increased risk of developing melanoma due to occupational sun exposure.

In early-stage melanoma, reliance upon clinicopathologic staging factors alone has been shown to result in a significant overuse of sentinel lymph node biopsies and miss patients with aggressive tumor biology. DecisionDx-Melanoma uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors, to improve patient outcomes and inform disease management decisions.

About Veterans Health Administration

The Veterans Health Administration (VHA) is the largest integrated health care system in the United States, providing care at 1,293 health care facilities, including 171 VA Medical Centers and 1,112 outpatient sites of care of varying complexity (VA outpatient clinics) to over 9 million Veterans enrolled in the VA health care program. VA Medical Centers provide a wide range of services including traditional hospital-based services such as surgery, critical care, mental health, orthopedics, pharmacy, radiology and physical therapy.

About Military Health System

The Military Health System (MHS) is one of America’s largest and most complex health care institutions, and the world’s preeminent military health care delivery operation. The MHS saves lives on the battlefield, combats infectious disease around the world, and is responsible for providing health services through both direct care through military treatment facilities and private sector care to approximately 9.6 million beneficiaries, composed of uniformed service members, military retirees and family members.

About U.S. Federal Supply Schedule

The U.S. Federal Supply Schedule (FSS), also known as the General Services Administration (GSA) Schedule and the Multiple Award Schedule (MAS), is a long-term government-wide contract with commercial companies that provide access to millions of commercial products and services at fair and reasonable prices to the government. MAS makes buying easy and efficient with the use of modern technology to connect government buyers and industry.

About DecisionDx-Melanoma

DecisionDx®-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic diagnostics company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx® -CMSeq), cutaneous squamous cell carcinoma (DecisionDx®-SCC), suspicious pigmented lesions (myPath® Melanoma, DecisionDx® DiffDx™-Melanoma,) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com.

Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix.

For more information, visit www.CastleBiosciences.com.

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

Forward-Looking Statements

The information in this press release contains forward-looking statements and information 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 DecisionDx-Melanoma’s ability to predict the risk of cutaneous melanoma metastasis or recurrence, as well as SLN positivity, independent of traditional staging factors, improve patient outcomes and inform and improve disease management decisions, and our contract with the VHA providing greater access to DecisionDx®-Melanoma for those within the VHA and MHS systems. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “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, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, subsequent study results and findings that contradict earlier study results and findings, DecisionDx-Melanoma’s ability to provide the aforementioned benefits to patients, our VHA contract’s ability to provide access to those within the VHA and MHS systems, and the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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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