Tempus Announces FDA-Approved xT CDx Test Launch Nationwide.

Tempus AI announced the national launch of xT CDx, a FDA-approved, NGS-based in vitro diagnostic device for solid tumor profiling. The test includes a 648-gene panel and provides comprehensive insights, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients. xT CDx uses a normal-matched approach, which can lead to more accurate identification of cancer-driving somatic variants. The test is now available for ordering clinicians nationwide.

Tempus AI, a leading healthcare technology company, has recently announced the national launch of its FDA-approved, next-generation sequencing (NGS)-based in vitro diagnostic device, xT CDx [1]. This innovative test is designed to provide comprehensive insights into solid tumor profiling, including microsatellite instability (MSI) status and companion diagnostic (CDx) claims for colorectal cancer (CRC) patients.

The xT CDx test utilizes a 648-gene panel, which covers a broad range of single nucleotide variants (SNVs), multiple nucleotide variants (MNVs), and insertions or deletions (INDELs) [2]. This extensive panel enables the identification of cancer-driving somatic variants with greater accuracy. The test employs a normal-matched approach, which compares the genetic makeup of the tumor to that of the patient's normal tissue, leading to more precise and reliable results.

The importance of MSI status in CRC diagnosis and treatment cannot be overstated. MSI-high tumors account for approximately 15% of all CRC cases and are characterized by a high mutation burden. These tumors typically respond better to immunotherapies, such as checkpoint inhibitors, compared to microsatellite-stable (MSS) tumors [3]. The xT CDx test provides MSI status designation, allowing clinicians to identify MSI-high CRC patients who may benefit from immunotherapy treatments.

Moreover, the xT CDx test includes CDx claims for CRC patients with KRAS wild-type tumors, making it an essential tool for personalized treatment planning. The test can guide clinicians in selecting appropriate treatment options, such as Erbitux® (cetuximab) for KRAS wild-type CRC patients [2].

The xT CDx test is now available for ordering clinicians nationwide, marking a significant milestone in the field of personalized cancer care. With its extensive gene panel, normal-matched approach, and CDx claims, the xT CDx test is poised to transform the way clinicians diagnose and treat solid tumors, ultimately improving patient outcomes.

References:

[1] Business Wire. Tempus AI Announces National Launch of FDA-Approved xT CDx, a Next-Generation Sequencing CDx for Solid Tumor Profiling. May 1, 2023. https://www.businesswire.com/news/home/20230501005375/en/

[2] Tempus. xT CDx Assay. https://www.tempus.com/life-sciences/xt-cdx/

[3] American Cancer Society. Colorectal Cancer: MSI-High and DMM-High Tumors. https://www.cancer.org/cancer/colon-rectal-cancer/about/microsatellite-instability-high-and-dmm-high-tumors.html