Caris Life Sciences has launched a new oncology blood test designed alongside AI modelling to pick up cancer at earlier stages.
Caris Detect is “designed to uncover cancer signals at earlier, more treatable stages,” Caris said in a statement.
The test uses ultra-deep whole genome sequencing, whole transcriptome sequencing and advanced artificial intelligence (AI).
It works by test assessing a wide range of molecular and biological signals associated with cancer, which the company says offers “a more comprehensive approach” than other tech that relies “on limited genomic snapshots.” This includes analyzing DNA, RNA and other biological patterns.
The test can then feed this into a dataset to tap its “highly sophisticated AI models” to detect subtle signals associated with early-stage disease across multiple cancer types.
Caris was feeling bullish on the launch, saying Detect’s “intended goal is to replace other outdated screening methods as the new standard of care for early detection of cancer.”
The diagnostic is based on the Caris Detect ACHIEVE 1 study, which assessed the sensitivity of its Detect system across a range of cancers at various stages.
Stage I had the least sensitivity rates (56% in total), but this went up for each stage, hitting 67.7% in stage II, 79% in stage III and 98.6% in stage IV.
Overall, sensitivity in stage I and II cancers hit 60.3% across multiple tumor types, including the most common: Lung, breast, prostate, bowel and skin, as well for pancreas, head and neck and uterus. Sensitivity was highest in head and neck (81.3%) and lowest in breast cancer (53%).
Finding cancers at these stages is the Holy Grail in cancer blood testing, when the diseases typically present with few to no symptoms and can be much more easily treated and potentially cured.
This latest test joins the company's other marketed diagnostics, including Cancer Seek assay, greenlit by the FDA in 2024, which examines 228 genes for single nucleotide variants plus insertions and deletions, as well as the cancer’s microsatellite instability status and tumor mutational burden, using both whole exome and whole transcriptome sequencing.
This allows the test to be used to find eligible patients for targeted treatments, such as Novartis’ Piqray (alpelisib) in breast cancers carrying a PIK3CA mutation; Amgen’s Vectibix (panitumumab) in wild-type KRAS and NRAS colorectal cancer; and a combination regimen for BRAF V600E-positive colorectal cancer with Pfizer’s Braftovi (encorafenib) and Eli Lilly’s Erbitux (cetuximab).
The company also launched in 2024 its Caris Assure plasma blood test for cancer therapy selection, which traces back genetic mutations to their origin.
Caris pulled off an IPO worth $494.1 million a year ago in its Nasdaq debut and is currently valued at $5.3 billion.