The MedCity News INVEST Digital Health Conference in Dallas brought together executives from the direct-to-consumer medical testing industry, who discussed the challenges and opportunities in this growing field.
Robert Weigle, CEO of NOWDiagnostics, highlighted the difficulties in obtaining funding and FDA clearance. He emphasized the complexity and high costs associated with developing diagnostic tests, noting that each study could cost around $2 million and involves numerous patients. NOWDiagnostics works on various tests, from syphilis to early pregnancy and strep throat tests, and is keenly aware of the challenges of reaching profitability and managing extensive clinical trials necessary for FDA approval.
Pranitha Patil, co-founder and COO of Function Health, spoke about the initial challenges of competing against traditional healthcare systems. Function Health, which charges $499 yearly for access to over 100 tests covering a wide range of health issues including heart health and cancer, had to navigate not only regulatory hurdles but also establish new partnerships with entities like Quest Diagnostics and various physician networks, which took about one and a half years to solidify. Currently, Function Health focuses on influencing behavioral change, encouraging members to actively engage in managing their health through the data provided by the tests.
David Stein, CEO of Ash Wellness, echoed the importance of patient participation in at-home diagnostic testing. He elaborated on the extensive efforts his company puts into patient engagement and the user experience to ensure completion and return of tests. Ash Wellness structures their pricing to incentivize the completion of tests, charging upfront for the test kit and partnering with labs that only charge for tests that are actually completed.
Salvatore Viscomi, CEO and co-founder of Carna Health, which specializes in kidney disease screening and testing, discussed navigating the sector by identifying key stakeholders, such as pharmaceutical companies, government bodies, and insurance companies, who benefit from early diagnosis and are thus more likely to support and fund the technology. Viscomi stressed that while advanced technology is pivotal, the greater challenge often lies in securing payment and support for these innovations.
Throughout the discussion, a recurring theme was the need to not only create advanced diagnostic tests but also to ensure these tests are utilized properly and lead to actionable health management. Educating potential users, engaging them effectively, and aligning the financial incentives across the value chain from patients to providers and payers are crucial to the success of direct-to-consumer medical testing companies. The industry, as depicted by the experiences of the panelists, sits at the junction of healthcare, technology, and consumer behavior, requiring multifaceted strategies to overcome the inherent challenges.
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