Caris Life Sciences Validates FDA-Approved MI Cancer Seek® for Precision Oncology

Caris Life Sciences Proves its FDA-approved MI Cancer Seek®

Announcement

Caris Life Sciences, a global patient-oriented, promising AI techbio company, released a study in Oncotarget validating the clinical and analytical potential of MI Cancer Seek. This regulatory-approved assay is considered a companion diagnostic (CDx) to address cancer patients who have a chance to benefit from focused therapies. The MI Cancer Seek is the first-ever test to merge whole transcriptome sequencing (WTS) and whole exome sequencing (WES) with its FDA-approved CDx for solid tumor profiling in pediatric and adult patients. This is ana prominent enhancement in precision oncology.

Specification of the Study

The study elaborates MI cancer seek’s reliability for addressing numerous variants of the highest clinical significance, also mentioning that the approved medical uses obey strict laboratory standards. The assay contributes to the eight companion diagnostics (CDx) claims, each identifying high clinical burden areas and specifying robust performance in comparison to other FDA-approved assays, along with negative and positive percent agreement starting from 97% to 100%. The MI cancer seek provides the additional benefit of multiple DNA and RNA extraction from reduced tissue input in comparison to other tissue-related assays that need single testing processes for RNA and DNA. This results in endless tissue requirements and delays.

Deserving MI Cancer Seek

MI Cancer Seek is a promising next-generation sequencing (NGS) related in vitro diagnostic (IVD) device approaching total nucleic acid (TNA) isolated from the formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the identification of single nucleotide variants (SNVs) and deletion and insertion (indels) in around 228 genes, tumor mutational burden (TMB), copy number amplification (CAN) in one gene in breast cancer patients, and microsatellite instability (MSI) in past diagnosed solid tumor patients.

The MI cancer seek was planned as a collaborative diagnostic to address patients who may benefit from treatment with the focused therapies, respective with the approved therapeutic product labelling. The MI cancer seek is designed to enable tumor mutational profiling to make it approachable for qualified healthcare professionals with the professional oncology guidelines for cancer patients with a past diagnosis of solid malignant neoplasms.

Views and Statements from the Company Leaders

MS, Phd, MBA, President of Caris, David Spetzler said, “MI cancer seek delivers a robust molecular blueprint that saves tissue without affecting results. The study results show our commitment to current scientific integrity and validation.”

Jr, MD, Caris EVP and chief medical officer, George W. Sledge, commented, “The vast related biomarker panels are main panels to enhance outcomes in precision medicine.”