New all-in-one blood cancer test may soon be available to US patients
Medicare-backed agency approves genetic test for myeloid malignancies
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A new genetic test for a group of blood cancers known as myeloid malignancies is expected to soon be available to certain people in the U.S. suspected of having one of these immune-cell-related diseases.
Caris Life Sciences, which sells the test, known as Caris ChromoSeq, announced in a company press release that the federal Molecular Diagnostic Services (MolDX) program — administered on behalf of the Centers for Medicare and Medicaid Services, or CMS — has approved its use.
CMS is the federal agency that oversees Medicare and Medicaid, publicly funded programs that provide health insurance for certain elderly, disadvantaged, and disabled people in the U.S. The MolDX approval, which follows a rigorous analysis of the genetic test’s performance and usefulness, will help inform decisions about coverage for the Caris ChromoSeq test, according to its developer.
“Securing MolDX approval for Caris ChromoSeq represents an important step in expanding access to highly informative genomic testing for patients with complex myeloid cancers,” said Matthew Oberley, MD, PhD, senior vice president, Caris’ chief clinical officer and pathologist-in-chief.
According to Caris, MolDX approval represents a step toward expanded access to the test and supports its utility.
Myeloid malignancies are a group of blood cancers defined by the abnormal growth of certain immune cells. These cancers are often very genetically complex: Myeloid cancer cells tend to have lots of mutations and changes to the genetic code in their DNA. These can include point mutations — changes in single nucleotides, the letters of the genetic code — as well as more complex genetic alterations, such as duplications or deletions of whole genes.
Caris ChromoSeq would replace suite of blood cancer tests
Traditionally, these different types of genetic changes are analyzed with specialized laboratory tests. However, patients often have to undergo a whole suite of tests to get a comprehensive assessment of their cancer’s genetics.
The Caris ChromoSeq test, launched earlier this year, sequences the entire genome with precise detail and at much greater coverage than other standard tests. This means the test should be able to detect all these different types of changes at once.
In addition to analyzing the genetic code, the Caris ChromoSeq test also examines the cellular transcriptome — that is, the sequences of RNA molecules produced when genes are turned on, or read as part of the process in which they’re used. As such, the test aims to be a type of one-stop shopping for a comprehensive overview of genetic alterations in people with myeloid malignancies. Such cancers include acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN).
Our goal is to replace fragmented diagnostic workflows with a single, comprehensive [test] that delivers clear, actionable insights to clinicians when time and accuracy matter most.
According to the company, the “results are consolidated into a single, easy‑to‑interpret clinical report to support timely treatment decisions.”
“Our goal is to replace fragmented diagnostic workflows with a single, comprehensive assay that delivers clear, actionable insights to clinicians when time and accuracy matter most,” Oberley said.
