Blood testing platform for early cancer diagnosis and treatment monitoring
Cancer is a major global health issue. In 2020, the new registered cases surpassed 19.2 M globally, whereas over 9.9 M deaths occurred due to cancer. Despite all the recent breakthroughs in cancer treatments, it is estimated that by 2040, the number of new registered cases and fatalities per year will increase to 30.2 M and 16.3 M, respectively (IARC). The NCI estimates that 39.5% of Americans will be diagnosed with cancer, unfortunately, many will lose their lives because of it. One of the main reasons cancer has such a high mortality rate is due to the current lack of tests with the required sensitivity and specificity to enable an early diagnosis of the disease. Moreover, there is a lack of technological resources to provide effective monitoring of the applied cancer treatments’ efficacy, which may significantly reduce the patients’ chances of survival given that the right treatment at the right time for each cancer patient may not be administered due to the lack of information available for physicians. Since there is an unmet need for tests that can reliably detect cancer at early stages and monitor the applied treatments’ effectiveness, the research community has been actively searching for novel biomarkers that can provide clinical information for these purposes. The isolation of circulating tumor cells (CTCs) from blood is a recent alternative that could address this need. CTCs have attracted a significant amount of attention for their potential use as a blood-based biomarker for a broad range of cancer-related clinical applications.
Current multiple cell sorting methods as fluorescent-activated cell sorting, magnetic-activated cell sorting, fluorescent-activated droplet sorting, and density gradient centrifugation are not compatible with whole blood samples and/or don't have the sufficient sensitivity and specificity to correctly isolate CTCs from blood, which have prevented the development of assays with potential clinical utility... until now. For our assay, a single blood tube is extracted by venipuncture. The blood sample along with several reagents are loaded on the CytoCatch™ isolation platform, which automatically performs the necessary steps to prepare and process the sample, capturing the contained CTCs. The unit has recovery rates above 94% when processing 7.5 mL blood samples spiked with tumor cells from prostate, breast, and colorectal cancer cell lines. Once captured, the CytoCatch™ isolation platform executes an automated protocol to stain the collected cells with fluorescent antibodies for their further analysis with the CytoCatch™ imaging system, which possesses special routines and machine learning algorithms that analyze the captured cells based on their morphology and the expression of specific markers. The fact that all these processes are fully automated increases the reliability and reproducibility of the assay by preventing human error and cell loss due to manual steps. Furthermore, the collected cells are compatible with traditional molecular biology techniques and next-generation sequencing technologies, enabling the performance of molecular analyses to assess the genetic characteristics of the captured CTCs. Finally, the treating physician will get a report with the corresponding results.
This past year, we managed to establish three new collaborations that will allow us to collect more samples to accelerate the clinical validations and sales of CytoCatch. One was with the radiology and imaging department of the university hospital Dr. José Eleuterio González where we are collecting samples from patients with advanced prostate cancer and from patients with a variety of benign diseases to be used as controls. A second with the urology department of the Hospital Ángeles where we will be collecting samples from patients with localized prostate cancer. And finally, a collaboration with the oncology department of the university hospital Dr. José Eleuterio González where we will be collecting samples from patients with breast cancer of various stages. We are also starting conversations with Bayer to establish a collaboration to use our technology for testing their Vitrakvi drug for the fusion NTRK genes on patients with thyroid and sarcoma cancers.