Caris Assure® Blood-Based Assay Shows Promise for Multi-Cancer Early Detection and Monitoring

Analysis reveals significant industry trends and economic implications

Release Date

2025-07-08

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Caris Life Sciences announced a study published in Scientific Reports demonstrating the accuracy and clinical utility of its Caris Assure® blood-based biopsy assay. This single assay combines comprehensive molecular profiling of over 23,000 genes across DNA and RNA in plasma and the buffy coat. The study validates Caris Assure®'s use in multi-cancer early detection (MCED), achieving high sensitivities and specificity. It also shows significant predictive power for minimal residual disease (MRD) and recurrence monitoring. Currently used for therapy selection, Caris is pursuing regulatory pathways to expand its use to early detection and monitoring.

Key Highlights

  • Caris Assure® is a multifunctional blood-based assay for cancer detection, prognosis, and prediction.
  • High sensitivity and specificity in multi-cancer early detection (MCED).
  • Significant predictive power for minimal residual disease (MRD) and recurrence.
  • AI-powered platform trained on extensive data sets.

Incidence and Prevalence

Global Cancer Epidemiology: Recent Estimates and Burden

Global Incidence and Prevalence of Rare Cancers

According to 2022 GLOBOCAN estimates, rare cancers (defined as those with an incidence rate of fewer than 6 cases per 100,000 individuals) accounted for 26.7% of all new cancer cases (5,347,784 cases) and 30% of all cancer-related deaths (2,959,369 deaths) worldwide.

Bladder cancer was the most common rare cancer, with an incidence rate of 5.58 per 100,000, followed by non-Hodgkin lymphoma (5.57) and leukemia (5.26).

Mortality rates were highest for pancreatic, esophageal, and brain cancers, reflecting their aggressive nature and limited treatment options.

Significant regional disparities were observed, with Europe and North America reporting the highest incidence rates for bladder cancer and leukemia, while Asia bore the largest absolute burden of rare cancers.

Cancer Burden Metrics and DALYs

A study on melanoma burden found 3.67 DALYs per melanoma case, 90.81 per 100,000 inhabitants, or 32.67 per death due to melanoma. Years of life lost (YLL) accounted for 80.4% of the total DALY for melanoma.

Stages I, II, III and IV patients at diagnosis generated 27.8%, 32.7%, 26.2% and 13.3% of the total YLL, respectively.

For time spent in each stage, localised melanomas, node metastatic melanomas, and distant metastatic accounted for 34.8%, 52.6% and 12.6% of the total YLD (years of life with disability), respectively.

Special Populations and Cancer Risk

In a study from Mexico, the standardized incidence ratio (SIR) of cancer in renal transplant recipients was 4.1 (95% CI 3.2-5.1) compared to the general population, based on GLOBOCAN 2012 data.

The relative risks of male and female transplant recipients were 4.6 and 3.5 times greater than the risk of cancer in the general population, respectively.

Regional Data: Canada

In Canada, using the 6/100,000/year threshold, the incidence proportion (IP) of rare cancers ranged from 9.7% (95% CI: 9.6, 9.7%) to 17.0% (95% CI: 16.9, 17.0%).

Using the <15/100,000/year threshold in Canada, rare cancers ranged from 19.2% (95% CI: 19.1, 19.3%) to 52.5% (95% CI: 52.0, 53.0%).

The adjusted probability of being diagnosed with a rare cancer was highest among those aged ≤19 years in Canada.

Methodological Considerations

The melanoma study used a melanoma disease model to predict patient evolution from diagnosis until death. The model was applied to 8016 melanoma patients recorded by the Belgian Cancer Registry for incidence years 2009-2011.

DALYs were calculated for each American Joint Committee on Cancer stage. Parametric uncertainty in the analysis was very limited, but using pre-2010 Global Burden of Disease approaches substantially influenced results.

The findings support the hypothesis that efforts for earlier diagnosis of melanoma are important. The proportions of DALY/YLL/YLD per stage could be extrapolated to other high-income countries.

Emerging Mechanism of Action

Emerging Mechanisms of Action for Cancer Treatment

Immunotherapy Advancements

Immunotherapy has revolutionized cancer treatment with several key approaches that have emerged as critical mechanisms of action:

  • Immune checkpoint inhibitors (ICIs) targeting PD-1, CTLA-4, and related pathways have become first-line clinical treatment options for certain tumors
  • ICIs show great efficacy in treating immunogenic or immune hot tumors such as melanoma, kidney, and lung adenocarcinoma, though they have limited response rates to non-immunogenic cancers
  • The FDA has approved PD-1/PD-L1 axis immunotherapy for PD-L1 positive cervical cancer
  • Monoclonal antibodies like pembrolizumab and cetuximab target specific cancer markers
  • Adoptive cell transfer methods including CAR-T cell therapy have shown potent antitumor effects both in vitro and in vivo
  • Cytokine therapy such as IL-2 and tumor vaccines stimulate immune responses

Novel Molecular Targets

Recent research has identified several promising molecular targets:

  • LILRB3 (Leukocyte immunoglobulin-like receptor type B) regulates differentiation and proliferation in acute myeloid leukemia
  • ICAM-1 (Intercellular adhesion molecule-1) plays a bidirectional role in tumor development
  • CENPN (Centromere protein N) has been identified as a potential oncogene in breast cancer and a new therapeutic target for immune checkpoint inhibitors
  • PTK7 (Protein tyrosine kinase-7) has emerged as a potential therapeutic target for human tumors, with overexpression in numerous cancers
  • Caldesmon has been proposed as a novel target for cancer therapy
  • USP28 (ubiquitin carboxyl-terminal hydrolase 28) enables oncogenic reprogramming by regulating protein abundance of proto-oncogenes

Combination Therapies

Combination therapies have shown enhanced efficacy:

  • ICIs plus tyrosine kinase inhibitors (TKI) demonstrated compelling results, with pembrolizumab plus lenvatinib showing significantly longer progression-free and overall survival in endometrial cancer patients
  • ICIs plus PARP inhibitors are being investigated in ongoing studies
  • HDAC6 inhibitors can increase sensitivity of cancer cells to chemotherapeutics and immune checkpoint blockade
  • HDAC1/2 inhibitors can block the mutant KBTBD4-HDAC1 interface and proliferation of KBTBD4-mutant medulloblastoma cells

Metabolic and Epigenetic Regulation

Emerging approaches targeting cellular metabolism and epigenetic regulation include:

  • N1-methyladenosine (m1A) modification affects tumor immune responses by regulating immune cells and modulating tumor microenvironment
  • Cuproptosis is being investigated as a novel cell death modality in colon cancer
  • AMPK (5-adenosine monophosphate-activated protein kinase) is emerging as a cancer treatment target
  • ERK1/2 in the RAS-RAF-MEK-ERK signaling pathway are being targeted with novel aromatic urea-imidazole salt derivatives
  • Metastatic cells frequently depend on mitochondrial respiration and oxidative phosphorylation (OxPhos), which can be exploited using drugs targeting mitochondrial metabolism
  • Metal complexes are being utilized to inhibit histone deacetylases (HDACs) and carbonic anhydrases (CAs)

Natural Compounds and Drug Delivery Systems

Several natural compounds and innovative delivery systems show promise:

  • Phytochemicals demonstrate anti-carcinogenic, anti-inflammatory, antiproliferative, anti-metastatic, and pro-apoptotic activities
  • Calycosin has been identified as a potential chemotherapeutic agent effective against approximately 15 different types of cancer
  • 6-shogaol from ginger possesses anticancer activities through multiple mechanisms
  • Tannic acid (TA) has attracted attention due to its anticancer, antiviral, and antioxidant properties
  • Maslinic acid (MA) impacts multiple cancer hallmarks by targeting various pathways
  • Metal-organic frameworks (MOFs) are being developed as nanocarriers for targeted cancer therapy
  • Plant-derived exosomes (PDEs) show promise as cancer therapeutics with less toxicity compared to traditional treatments
  • Next-generation ADCs (antibody-drug conjugates) have demonstrated exciting results in breast cancer treatment

Microenvironment and Immune System Modulation

The tumor microenvironment (TME) and immune system modulation represent key areas of focus:

  • Targeting the gut microbiome which influences efficacy of immune checkpoint inhibitors
  • N-linked glycosylation of PD-L1/PD-1 has shown significant increase in efficacy of PD-L1/PD-1 blockade therapy
  • Targeting proliferating resident macrophages in pancreatic ductal adenocarcinoma can alleviate fibrosis and immunosuppression
  • NLRP3 inflammasome modulation is being investigated for triple-negative breast cancer treatment

Drug used in other indications

Caris Assure® Non-Cancer Indications and Trial Models

Based on the provided context, there is no specific information available about Caris Assure® being trialed for indications other than cancer. The context does not contain details about:

  • Non-oncological indications or disease states for which the Caris Assure® blood-based molecular profiling platform is being evaluated
  • Clinical trial methodologies, intervention protocols, or therapeutic approaches being utilized in Caris Assure® studies for conditions other than malignancies
  • Intervention models for any trials involving Caris Assure® for non-cancer indications

Without specific information in the provided context, it is not possible to provide details about non-cancer applications of Caris Assure® or the associated trial methodologies.