Our industry has long been ripe for disruption and transformation – even before the pandemic. According to a 2017 Forrester study, healthcare lags a decade behind other industries in adopting consumer engagement technologies. In fact, only 32% of physicians and 27% of consumers believe that the U.S. healthcare system performed well in terms of introducing technology, reports a 2019 Ernst & Young survey.
In the same vein, lab testing has remained largely unchanged for more than twenty years. When almost everything is available to us with the click of a button, our own healthcare data – the most fundamental information about who we are – is still incredibly challenging to get our hands on and interpret. Patients need to wait days to weeks for their test results, adding unnecessary stress to what is often already an anxiety-filled process. And when results finally become available, patients have little to no direct access to their data – not to mention, an expensive bill for even the most common tests. The status quo for blood testing and diagnostics has been broken for all stakeholders involved: patients, providers, payers.
But what about now? What is the state of blood diagnostics in 2021?
The COVID-19 pandemic exposed the need for accurate, rapid, and deployable diagnostic testing that is accessible and affordable to all. We can do better. We must do better.
Over the last year, we’ve seen a heightened and sustained demand for diagnostic tools to combat the pandemic. As of August 2020, there were 448 COVID-19 related diagnostics launched in the market or in development. Diagnostics has been the highest-performing Medtech segment, recording 12.2% revenue growth. Since March, more than 200 million COVID-19 tests have been shipped to hospitals, clinics, and community testing sites on the front lines of the pandemic. And analysts expect this demand for diagnostics to continue well beyond 2020.
The way that we test for, diagnose, treat, and manage disease is entering a new era. Routine testing is moving closer to the consumer – and away from the inefficient and expensive centralized lab model of yesterday. Accuracy no longer needs to be sacrificed for convenience or speed, as the new generation of point-of-care (POC) tests can achieve comparable results to lab-based testing at a fraction of the cost. And beyond convenience, POC tests can deliver upon the promise of value-based care by improving workflow efficiency and increasing cost-effectiveness. Let’s take a closer look at each of these non-negotiables for POC diagnostics.
Quality comes first and cannot be compromised for any reason. POC tests need to undergo rigorous scientific verification and independent evaluations in clinical laboratories to demonstrate accurate and precise results. To close the gap for routine wellness tests, it’s critical for benchtop diagnostics to demonstrate comparable sensitivity and specificity levels with centralized lab machines. Lab-accurate POC test results will ensure that patients can focus on the treatment plan recommended by providers, rather than worrying about whether or not their results were reliable.
Consumers expect convenience across all areas of their lives – and healthcare is no exception. In a 2019 NRC Health survey of over 223,000 healthcare consumers, 51% indicated that convenience and access to care are the most important factors in their decision-making process – ahead of insurance coverage (46%), doctor/nurse conduct (44%), brand reputation (40%), and quality of care (35%).
By moving blood testing closer to where people live and work, we can significantly reduce the wait time for patients to receive their results. When we make it easier for consumers to access their health information, we also make it easier for them to become empowered partners in their health and wellness journeys. In turn, activated patients are more likely to engage in preventive care and healthy behaviors – and ultimately, experience better health outcomes across metrics such as blood pressure, cholesterol, BMI, and hemoglobin A1c.
Today, the average single healthcare deductible is $1,644 – up sharply from an average of $917 just one decade ago. And health-related expenses account for 14% of Medicare household expenditures and 6% of non-Medicare household expenditures, according to a 2018 Kaiser Family Foundation analysis. With the increased financial burden for healthcare-associated costs, Americans are seeking options that will lower their out-of-pocket expenses.
Currently, there is no affordable way for consumers to monitor their key wellness indicators. Point-of-care diagnostics will play an important role in expanding access to critical healthcare services, as high costs can deter patients from getting the care they need.
To activate patients in their care plan, providers need to ensure that patients understand, adopt, and act on interventions within the context of their day-to-day lives. To empower consumers to be in control of their own personal health data, we need to translate information into insights. It is important to address communication barriers, such as limited health literacy and the use of medical jargon, as they can significantly impact health status, patient outcomes, and overall healthcare utilization.
Diagnostic tests need to be actionable for the provider to recommend the most effective treatment – and to provide patients with the clarity and direction to manage their own care. Time is an important variable for patient-centric experiences, as consumers will benefit from immediate clinician guidance after receiving their test results.
So how are we elevating the standard for POC blood tests?
As a life science entrepreneur, I co-founded Truvian with the vision of making routine health testing convenient, affordable, and actionable for today’s connected consumers. At Truvian, everything that we do comes back to our core mission of giving individuals unprecedented access to the information that shapes their health. We believe in a world where consumers can walk into a clinic, complete their routine wellness tests within 20 minutes using just a small blood sample, and engage in a real-time conversation with the healthcare provider about what those results mean for their individual health trajectories in the context of their lives. This is the reality that we are working towards – gone are the days of treating patients with a “one-size-fits-all” approach, enduring the pain of multiple tubes of blood samples, or holding our breath for weeks as we await a test result.
The pandemic has served as a catalyst for innovations in reliable, quick, and easy diagnostics. By shifting routine testing to the point of care, we can empower consumers with regular insights into their health. This approach to better blood testing will improve health outcomes, consumer experiences, and access to care – ultimately, keeping our communities healthier.
Dena Marrinucci, PhD
COO and Co-Founder
Dr. Marrinucci is a life science entrepreneur with a passion for introducing diagnostic technologies with potential to transform human health. She co-founded Truvian in late 2015 and leads research, operations, program management and strategic partnerships for the company. Prior to founding Truvian, Dr. Marrinucci founded Epic Sciences in 2008 and was the company’s Chief Scientific Officer. During her tenure at Epic, Dr. Marrinucci developed a novel circulating tumor cell technology and helped grow the company, overseeing its diagnostic collaborations with pharmaceutical companies and developing its clinical laboratory and assay development operations.
Dr. Marrinucci has been named to MIT Technology Review’s 35 Innovators Under 35, Foreign Policy’s Top 100 Leading Global Thinkers, PharmaVoice 100’s Top Entrepreneurs, The Daily Transcript’s 40 Under 40 Business Professionals, and Stella Labs’ Entrepreneur of the Year. She was also named a 2016 Life Science Catalyst Award winner, has authored dozens of peer reviewed publications and is an inventor on 12 patents. Dr. Marrinucci also serves as an Advisor for Lynx Biosciences, a cancer diagnostic company. She holds a B.S. in Chemistry from the University of Vermont and a Ph.D. in Chemical Biology from The Scripps Research Institute.