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local coverage determination

The company's AlloSure Kidney test received coverage, along with its AlloSure Heart test when used with the firm's AlloMap test.

Novitas added multiple leukemia biomarkers to its coverage determination, as well as the ThyGeNEXT molecular panel.

The tests are covered when the patient has a personal history of melanoma and the test has demonstrated clinical and analytical validity.

The test assesses multiple factors, including single-/multi-nucleotide variants, short insertions and deletions, and microsatellite instability status.

A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.

Under the LCD, oncology biomarkers must have proven clinical validity and there must be acceptance of specific testing into patient management.

The general LCD is covered for patients with a personal history of melanoma undergoing workups or being evaluated for treatment without metastatic disease.

The firm said that it has secured coverage for about 100 million lives for its targeted NGS liquid biopsy test in the US between Medicare and private payors. 

CareDx hopes the final LCD for AlloSure Heart will lead to an approval of HeartCare, a combination of AlloSure Heart and AlloMap Heart.

The genomic test is covered by Medicare for all men with localized prostate cancer being considered for treatment.