IRVING, Texas—Caris Life Sciences recently announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device designation for the company's MI Transcriptome companion diagnostic (CDx) test, for detection of novel FGFR biomarkers including gene fusions in solid tumors. This is reportedly the first CDx test to detect gene fusions across all solid tumors. Caris expects to submit for pre-market approval later this year.
“The FDA Breakthrough Device designation for the MI Transcriptome CDx assay is a significant step in advancing precision cancer care for individuals with specific genetic profiles who could benefit from targeted treatment options,” said Dr. W. Michael Korn, chief medical officer of Caris. “This also is an incredible milestone for Caris and the company’s efforts to advance molecular science and cancer care by employing cutting-edge technology for the detection of highly actionable molecular alterations.”
MI Transcriptome CDx is a next-generation sequencing-based in-vitro diagnostic test that uses RNA isolated from formalin-fixed paraffin-embedded tumor tissue to detect all classes of structural rearrangements, including fusions, deletions, inversions and duplications, as well as measuring expression and splice variants in patients diagnosed with cancer.
The assay can also provide additional tumor profiling data to be used by qualified healthcare professionals in accordance with professional guidelines in oncology for patients with cancer.
“RNA-based sequencing analysis is emerging as the best method to detect clinically relevant fusions," remarked Dr. David Spetzler, president and chief scientific officer of Caris. “MI Transcriptome CDx, which is enabled by Whole Transcriptome Sequencing, provides information on all genes that are expressed in the cancer, which allows the most complete assessment of a patient's tumor to inform more targeted treatment. We are delighted to have received Breakthrough Device designation and look forward to accelerating development of this assay.”
Earlier this year, Caris launched the newest addition to its comprehensive genomic profiling offering, MI Transcriptome, which enables whole transcriptome sequencing. It builds upon Caris' offering of the most comprehensive tumor profiling approach, which assesses DNA, RNA and proteins to ensure patients receive the right therapies.