Castle Biosciences Announces Expanded Medicare Coverage for DecisionDx-Melanoma in Cutaneous 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. The test has been studied in more than 5,700 patient samples.
“We are pleased to have received positive expanded coverage for our DecisionDx-Melanoma test for patients diagnosed with cutaneous melanoma,” said
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. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. 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
About
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
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 the ability of DecisionDx-Melanoma test results to predict recurrence and metastatic risk in patients with invasive cutaneous melanoma and optimize or improve diagnostic treatment decisions. 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, changes in the competitive landscape and the introduction of competitive products, changes in local coverage determinations, the impact of the COVID-19 pandemic on our business and results of operations, as well as the other risks set forth in our Annual Report on Form 10-K for the year ended
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Castle Bio Receives Expanded Medicare Coverage for Melanoma Test
NEW YORK – Castle Biosciences announced Thursday its DecisionDx-Melanoma test has received expanded coverage from Medicare Administrative Contractor Palmetto for patients with cutaneous melanoma.
The future local coverage determination released by Palmetto covers molecular diagnostic tests to assist in risk stratification of melanoma patients when the patient has a personal history of melanoma and has either stage T1b and above or has stage T1a with documented concern about the adequacy of microstaging. They must also be undergoing workup or being evaluated for treatment, not have metastatic disease, have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy, and has a disease stage, grade, and Breslow thickness within the intended use of the test. The expanded LCD establishes a 0.3mm and thicker threshold for any use of the test, lower than the original coverage, according to an analyst note from SVB Leerink's Puneet Souda.
The tests covered in the LCD must have demonstrated through a technical assessment the clinical validity of analytes tested in predicting metastatic disease in peer-reviewed scientific literature, as well as utility beyond clinical, histological, and radiographical factors to accurately stratify patients into risk groups. It must also demonstrae appropriate analytical validity and performance characteristics equal to other similar, covered tests.
The LCD covers these tests generally but cites an evaluation of the DecisionDx-Melanoma test in its evidence review, and the company confirmed the gene expression profile test is included under the expanded coverage decision. Palmetto's LCD goes into effect for services covered on or after Nov. 22. Another MAC, Wisconsin Physicians Service Insurance Corporation, aligned its coverage with Palmetto's, and its LCD goes into effect the same day.
Castle Bio's test uses a patient's tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, along with sentinel lymph node positivity. Palmetto originally released a draft LCD proposing expanded coverage for the test last year.
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