The diagnostics sector has benefited from a few trends in the past five years that not only have the potential to transform how we screen for cancer but also detect chronic conditions— such as cardiovascular disease— earlier, which could lead to better health outcomes. Additionally, the Covid-19 pandemic changed the way we think of the role of diagnostics not only for clinicians but also consumers. The pandemic propelled innovation in the in vitro diagnostics and at home test kits space for chronic conditions, sexual health and more. We’re seeing the results of this work in the form of alliances between testing companies, lab giants and national retailers.
HLTH 2023, scheduled for October 8-12 at the Las Vegas Convention Center, will spotlight some of these developments in panel discussions throughout the week. To register, click here.
Investment and M&A deal activity
Investment in diagnostics testing has shifted to at-home testing and decentralized testing, according to a KPMG report published last year. One notable acquisition last year was Sorrento Therapeutics’s purchase of Virex Health, a Boston University spinout that leverages the manufacturing infrastructure used for glucometers and glucose strip tests to offer affordable and highly scalable tests for Covid-19 tests, early liver cancer detection, inflammation and hormone monitoring. The report also called attention to innovative approaches to testing such as the $80 million investment in Sherlock Biosciences, which is developing a CRISPR-based diagnostic platform. Sherlock’s acquisition of Sense Biodetection earlier this year, underscores the decentralized testing trend.
The momentum for at-home testing is expected to continue. One report predicts that the global market for direct-to-consumer lab services will double to $2.4 billion annually by 2025.
Perspectives
Dr. Bobbi Pritt, a microbiologist and pathologist with Mayo Clinic, highlighted some of the innovations in diagnostic testing that give her encouragement in response to emailed questions. particularly advances in digital imaging and artificial intelligence.
“AI algorithms, for example, can be applied to 2-or 3-dimensional digital images to identify cancers or infections in tissues and even analyze metabolic pathways in support of drug discovery,” Pritt noted. “At Mayo Clinic, we have already validated and implemented several AI algorithms for routine clinical use and are working with industry partners to create new AI tools for advancing patient care.”
Pritt pointed out that detection of human papillomavirus, (HPV) through minimally invasive testing specimens such as blood and vaginal specimens is a great example of a specific test innovation.
“HPV is responsible for nearly all cases of cervical cancer worldwide and is also an increasingly common cause of cancers of the head and neck. At Mayo Clinic, our studies show that patients can accurately collect their own vaginal specimens at home for HPV testing, which could revolutionize cervical cancer screening. We are also studying the detection of HPV in whole blood samples to detect cancer recurrence in patients with HPV-associated oropharyngeal cancer, thus allowing for rapid interventions.”
The aggregation and analysis of healthcare data over several years has helped research scientists predict the likelihood of cardiovascular disease in patients later in life. For example, heart disease risk factors identified even in childhood are linked to later heart trouble. This was a finding of a prospective cohort study involving participants in the International Childhood Cardiovascular Cohort (i3C) Consortium, shared by the American Heart Association. Based on the presence of five risk factors during youth— high body mass index, high systolic blood pressure, smoking, and high total cholesterol and triglyceride levels — there was an increase in the risk for having a cardiovascular event beginning as early as age 40. In an analysis of data on nearly 40,000 people enrolled in seven different studies in the 1970s and 1980s, researchers found that risk factors identified among study participants when they were 3 to 19 years old were associated with cardiovascular events more than 30 years later, according to the study.
One expectation for diagnostic innovation is improved detection for cancer and other chronic conditions by enabling screening for diseases earlier than currently available. Advanced Research Projects Agency for Health (ARPA-H) Director Dr. Renee Wegrzyn, who will take part in the HLTH event in October, observed that there are several innovations happening in the diagnostics space.
“There are new avenues to radically accelerate early, scalable, and non-intrusive detection of impending disease, and new ways to leverage the increasingly enormous amounts of health data for better treatments or preventions, leveraging insights into systems from the molecular to the societal level. I also see many opportunities where we can maximize ARPA-H’s impact by ‘moving big levers and removing key tradeoffs’ in the health ecosystem that currently limit progress. Let’s start with rethinking why we have a particular problem and identify what changes can be made to over overcome it. The solution might end up being inspired by a technology that was not originally developed with health in mind.”
Companies to watch
There are some particularly interesting companies in the diagnostics space to watch, in addition to those mentioned. Harbinger Health is a biotech company using healthcare data to improve early detection of cancers through blood assays. It received a $50 million investment from backers including At ASCO this year, the company published the results of a study of more than 1,000 people predicting the likelihood of cancer using a multi-layered logistic machine learning algorithm.
Harbinger is in the process of a 10,000-subject clinical trial for Cancer Origin Epigenetics in conjunction with the Sarah Cannon Research Institute.
Simple HealthKit inked a deal with Walmart in June to distribute its at-home testing kits for diabetes (HbA1c), respiratory wellness and sexual health at the national retailer. The deal follows an $8 million Series A round in April led by Initialized Capital. Kleiner Perkins, Kapor Capital and Quest Venture Partners also participated in the deal.
Predictive analytics and diagnostic innovation seem to be destined to converge with the ability to analyze personal healthcare data using machine learning tools and prescribe tests for patients earlier. The increased availability and diversity of home testing kits give consumers the ability to make their own testing decisions in a timely manner. Developments in molecular diagnostics and cell therapies like CAR-T will pave the way for more sensitive diagnostics to detect cancer and other life-threatening conditions earlier, positioning clinicians to improve clinical outcomes. It will be interesting to see how these developments progress in the coming years.
To be part of the dynamic conversations at HLTH, follow this link to register.
Photo: georgeclerk, Getty Images
