The number of tumors detected in the world population is increasing dramatically, with cancer being the second-leading cause of death worldwide. Since 1990, the estimated number of people with cancer has more than doubled from 45 million to 100 million people. Higher-income countries have demonstrated a higher prevalence of cancers, especially due to lifestyle factors such as smoking, alcohol intake, lack of exercise, diet, and obesity. That has led to an increased attention towards detection, as early cancer diagnosis is essential to guarantee a high chance of patient survival.
Current cancer diagnostic tools involve invasive procedures such as biopsies; however, in a high number of cases these painful procedures could be avoided if the lesion were better characterized. Moreover, the high costs of these invasive biopsies and the fact that they are associated with painful procedures lead patients to delay or avoid the procedure, resulting in not enough people being diagnosed or patients being diagnosed in a later stage of the disease. This results in higher mortality rates and more complex and expensive treatments. All these factors make a clear case for the need to develop noninvasive diagnostic tool that could characterize the lesion tissue accurately, achieving an early diagnosis with high specificity to avoid false positive results and unnecessary invasive biopsies. Furthermore, noninvasive biopsies will cost significantly less than the standard open surgical biopsy.
New noninvasive tools that allow real-time cancer tissue characterization, so-called smart biopsies, have been developed and are already being used in some hospitals to accelerate cancer diagnosis. Taking these projects from the lab bench to a clinical context will make diagnosing cancer faster and cheaper, resulting in patients getting access to the right treatment earlier and representing a clear opportunity for the players that will bring them there.
SmartTarget –Targeting prostate cancer diagnosis:
One of these technologies, SmartTarget, was developed at University College London Hospitals and funded by the United Kingdom’s Department of Health and the Wellcome Trust. This software, which allows for the overlaying of tumor information from magnetic resonance imaging scans onto ultrasound images, was developed to improve prostate cancer diagnosis. With this new technology, surgeons will have important information about the size, shape, and location of prostate tumors, helping to guide the surgeon to the tumor location during the biopsy.
According to the results published in European Urology, this technology enables surgeons to pick up clinically relevant cancers that were missed when using current imaging detection methods. In fact, this new technology has improved detection rates close to 90% compared to previous established imaging procedures that had a detection rate of 50% in the last five years. This software has been commercialized by SmartTarget Ltd, a company spun out by UCL’s commercialization company UCL Business PCL, and is already being used in hospitals in the United Kingdom and the United States.
SOLUS – Innovation tool in the diagnosis of breast cancer:
Politecnico di Milano in a joint project with several academic, clinic, and industrial(such as iC-Haus GmbH, a leading German manufacturer of integrated circuits and SuperSonic Imagine, a French corporation acting in the ultrasound medical imaging field) partners named the SOLUS project (for smart optical and ultrasound), developed a novel diagnosis of breast cancer using ultrasound and diffuse optics, an imaging technique that is particularly useful for the measurement of tissue hemodynamics. This new, noninvasive imaging system, called a “smart optode”, consists of a newly developed detector and high-performance laser and timing electronics that will help to classify breast lesions, differentiating between benign and malignant lesions. The SOLUS system will reduce the number of invasive biopsies by improving the characterization of lesions in breast tissue more quickly, leading to more effective and economical treatment of breast cancer and avoiding unnecessary biopsies.
The SOLUS project started in 2016 and is a four-year research project that is being funded by the European Commission under the Horizon 2020 Framework Programme. Over the last few years, the project has focused on the development of the SOLUS system prototype. Moreover, a pilot clinical study on patients with benign and malignant breast lesions has already been designed to validate the feasibility and usability of the system. Furthermore, in vivo validation of the prototype in healthy volunteers and breast cancer patients is going to start in 2020, according to Dr. Peter Gordebeke, Project Manager at the European Institute for Biomedical Imaging Research. In the future, this system for smart biopsies will be incorporated into a commercially available ultrasound system from SuperSonic Imagine.
A new tool to perform painless skin cancer biopsies:
A project at Michigan State University is developing a new tool to perform a noninvasive alternative to skin cancer biopsies. The current established procedures to detect skin cancer are based on the pathological analysis of a small section of skin tissue cut from the patient. To replace the invasive biopsy procedure and the need for the sample’s pathological analysis, a technology using laser microscopes that can selectively excite compounds to identify molecules was developed and published in the journal Nature Photonics. This imaging technique allows greater specificity and the ability to map different chemical species even in the presence of interfering species such as cholesterol. This allows for the identification of the tumor lesion without the need for an invasive biopsy.
The work is funded in part by the National Science Foundation. The technology was further developed by Biophotonics Solutions Inc., a spin-out from Michigan State University, and it was acquired by IPG Photonics in 2016.
More recently, a new collaboration with the University of Illinois Urbana-Champaign has developed an optical imaging platform based on multiphoton microscopy that could characterize the tumor microenvironment, after excising a small part of the tissue, thus substituting the need for preparation and interpretation of histological images of the tissue, which is a highly time- and labor-intensive procedure, to accelerate the diagnosis time.
SmartGuide – Smart biopsy tool for real-time cancer tissue characterization:
Dune Medical Devices has developed a device called SmartGuide based on radio frequency technology that can analyze human tissue using electrical sensors in real time during biopsy procedures. Different types of tissues present different electrical properties that can be measured using this technology. SmartGuide can therefore guide the clinician to the most suspicious tissue, allowing a more accurate biopsy and avoiding misdiagnosis of patients and the need for repeat biopsies, which currently occurs in 18% of breast cancer patients. In fact, with this real-time information, clinicians can analyze more accurately a suspected cancer area of a patient, making sure that the excised tissue represents the most advanced stage of the disease so the histological analysis will lead to an accurate diagnosis.
This project was funded by the European Commission under the Horizon 2020 Framework Programme, and this technology has been incorporated in the MarginProbe device developed by Dune Medical Devices. Ex vivo trials using excised tissues demonstrated that the device can differentiate between benign and cancerous tissues with 84% accuracy. In vivo human clinical trials have already begun with patients with breast lesions.
Smart biopsies in the era of personalized cancer care:
The diagnosis and treatment of malignant cancers is an invasive and expensive procedure. In fact, the United States is spending an estimated $7.9 billion USD annually for unnecessary cancer biopsies, in particular for prostate and breast cancer biopsies, as a result of using old, less sensitive technologies to diagnose these cancers. Furthermore, tissue biopsies often result in benign results, with approximately 80% of breast and prostate cancer biopsies resulting in a benign diagnosis.
A look at the liquid biopsy market show a staggering 40% (CAGR) expected growth over the next 5 years supporting the notion that there is a need for simple, non-invasive procedures within this space. Smart biopsies can become part of that answer as a cost-effective, painless and more accurate solution that insurers will likely be happy to support as some of these technologies transition into products and prove their effectiveness within the clinical field.
