Ashion's GEM ExTra assay receives Medicare coverage

Ashion Analytics LLC announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostic Services Program (MolDX), has awarded coverage to its proprietary cancer profiling test, GEM ExTra®, one of the nation's most comprehensive genomic cancer analysis tests.

GEM ExTra, Ashion's flagship clinical assay, detects tumor-specific mutations, allowing physicians to make the best-available treatment recommendations for patients with advanced solid tumors. The leading-edge test provides treating physicians with vital interpreted information that they need to understand changes to a patient's genomic profile.

It outlines a therapeutic treatment plan best suited for each patient. Conditions that may benefit from this approach include the treatment of refractory, rare, or aggressive cancers.

"GEM ExTra was designed to be fast and accurate, and now with Medicare coverage, it is also more affordable for a larger set of patients," said Ashion Medical Director Janine LoBello, D.O. "GEM ExTra differs from other genomic tests on the market due to its versatility, breadth, and depth, including the power to sensitively detect mutations with low tumor purity."

GEM ExTra features whole-exome sequencing, a molecular-level analysis of each patient's entire protein-coding DNA. The proprietary test identifies point mutations, amplifications, deletions, translocations, and transcriptome sequencing. It flags the expression of both rare and common fusion genes and alternatively spliced transcripts (ARv7, EGFRvIII, and others).

Positive findings in this data may guide patient treatment, leading to more targeted, effective therapies. As an example, the test includes reporting on immuno-oncology markers, providing clinicians with important information on the potential utility of powerful immune checkpoint treatments.

GEM ExTra is available for use with a variety of biological sample types, including formalin-fixed paraffin-embedded (FFPE) tissue specimens and fresh-frozen tissue for solid tumors. Results are reported back to physicians within 14 calendar days.

Medicare coverage of GEM ExTra allows Ashion to offer a test to the broader market that is optimized for detection of common and rare mutations and is able to identify more actionable cancer mutations than most other commercially available tests."

Audrey Ozols, Head of Market Access, Ashion Analytics, Translational Genomics Research Institute

"The company is well-positioned for growth with payers and physicians alike by offering 44 million more patients access to a best-in-class comprehensive genomic cancer test."

Ashion Analytics was founded by the Translational Genomics Research Institute (TGen), an affiliate of the City of Hope. TGen is a pioneer in the use of genomics to identify treatment options for cancer patients.

"City of Hope patients have had access to GEM ExTra's comprehensive exome sequencing for more than two years," said Michael Caligiuri, M.D., president of City of Hope National Medical Center and the Deana and Steve Campbell Physician-in-Chief Distinguished Chair.

"This sequencing tool often enables clinical teams to offer precision medicine so that patients are given the care most likely to put them into long-term cancer remission and improve their quality of life."

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