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DeciBio Weekly Digital Health Digest
Volume 10 — March 24, 2020
Digital health innovators have rushed in to meet the demand for new diagnostics and patient management tools to combat COVID-19. While the crisis has enabled some digital solutions (e.g., telehealth, chatbots / symptom checkers) to demonstrate value and help erode barriers to adoption, roadblocks remain before seeing the scale of digitization optimistic industry onlookers forecasted. 

Here's your roundup for the week:
DeciBio Original Content
As more COVID-19 diagnostics win FDA emergency use authorization, weekly commercial production capacity is expected to hit 6.5M+ tests; telehealth providers attempt to jump into the fray, but are subjected to additional FDA oversight
After a series of missteps by the CDC and Trump administration to develop COVID-19 diagnostics at-scale and mount effective outbreak management testing protocols, production of much-needed tests is finally ramping. By April, major U.S. commercial manufacturers are expected to exceed production of 6.5M tests per week (see Figure 1 below). By comparison, South Korea, whose quick implementation of testing has helped contribute to a declining incidence rate, produces ~700K tests per week; implementing a comparable per capita scale of testing in the U.S. would require weekly production capacity of ~4.5M tests. Following FDA Emergency Use Authorization (EUA) for diagnostics behemoths like Thermo Fisher, Roche, Hologic, and Abbott, direct-to-consumer testing companies hoped to follow suit and support this production target  with “closed-loop” solutions — mail-order test kits paired with telehealth consultations. 
Source: DeciBio Analysis of company statements (see Thermo Fisher, Abbott, Roche, Hologic, Cepheid, DiaSorin)
Adoption of telehealth solutions has surged in the wake of COVID-19, driven by the value of conducting patient assessments and testing without risk of transmission and expanded reimbursement and use guidelines from Congress and CMS. In light of this, five telehealth players — Nurx, EverlyWell, Carbon Health, myLAB Box, and Scanwell Health — announced plans to commercialize COVID home-testing kits in the last week. While the FDA quickly and decisively passed diagnostic incumbents through EUA, the agency issued a statement clarifying that no at-home test is approved and that additional oversight for at-home tests is underway. This comes as no surprise — while the FDA and CMS have shown considerable flexibility and deregulation in the name of urgency, pumping the brakes on players taking these tests outside of established healthcare infrastructure is merited. While at-home diagnostics for the virus can expand access, several issues remain: (1) EUA is unlikely for companies without a track record of diagnostics expertise that incumbents in the space have; (2) these tests would require self-administration of a nasopharyngeal swab, which can easily be contaminated or incorrectly performed; (3) these tests retail for $150-200 and are unlikely to be covered by insurance; (4) time to result would likely be poor, as consumers would need to wait for the test to arrive before sending it to a centralized lab (which can already take up to a week to yield results); and (4) nascent companies may not be prepared to handle logistics at-scale to ensure reliable testing.

If able to successfully demonstrate test validity and capabilities to manage the scale of remote testing the crisis demands, telehealth diagnostics players can help chip away at the U.S.’ test capacity deficiency (see Figure 2). Once accessible testing is rolled out at-scale, more targeted isolation and disease management policies can be instituted and more reliable epidemiological tracking and surveillance can occur. 
Recent Headlines
Market Activity
Telemedicine faces the test of scalability as it reaches inflection point in COVID-19
TLDR: As telemedicine sees rapid uptake in light of COVID-19, telehealth vendors are frantically working to meet rising demands. American Well is experiencing difficulties with long wait times and platform crashes. Though not facing IT glitches, direct-to-consumer telemedicine services like Doctor on Demand and 98point6 are looking to rapidly hire clinicians to meet demand for appointments.

So what? In the face of unprecedented teleconsultation volumes, the key issue limiting scalability for telemedicine is infrastructure, both in terms of IT and clinician resources. As telemedicine vendors ramp up to meet these challenges, they see an opportunity for sustained adoption post-pandemic. Hill Ferguson, the CEO of Doctor on Demand, reports that only half of patient volumes are those that suspect Coronavirus infection. The other half of patients are seeking routine care virtually to avoid in-person contact. As patient volumes increase, more individuals are learning to use telemedicine and will be more likely to continue using these tools in the future. 

Evidation Health launches longitudinal digital study of US residents' COVID-19 perceptions, behaviors
Source: Rock Health, Evidation Press Release — "Over 140,000 (as of March 22) people from across all 50 states and the District of Columbia have agreed to participate, recruited in less than seven days from the nearly 4 million people who use Evidation’s Achievement app—the largest, most diverse virtual research site in the U.S. This effort will track attitudes, behaviors, and health on a regular basis over the course of the coronavirus pandemic.”

TLDR: Evidation Health, a tech company that generates insights from real world behavioral data collected through devices, has recruited 100,258 people living in the U.S. into a longitudinal survey through their Achievement app. Participants log their COVID-19 perceptions and behaviors (e.g., perceived preparedness, hand washing practices, physical activity, and group gathering activity) which links to device-tracked data synced with the app.

So what? As new cases skyrocket in the U.S., Evidation contributes to the myriad of data-driven (digital and other) initiatives to track the COVID-19 outbreak (JHU’s global tracker, Singapore’s TogetherTrack app for contact tracing, Bouy Health’s epidemiological data collection). By combining patient-reported information as well as device data,  Evidation Health’s new study puts real world evidence and digital studies to the test in a time of crisis. The study could prove to be a scalable public health surveillance tool, though concerns over participant retention and unrepresentative sample population exist.

AWS launches Diagnostic Development Initiative for researchers working on point of care COVID-19 diagnostics

TLDR: Amazon has invested $20 million in its latest initiative to combat COVID-19. The program is open to research institutions and private entities working to develop diagnostic tests with same-day turnaround time. The initiative aims to support researchers through AWS’ cloud infrastructure and leading analytics services. Participants in the program will access funding through AWS credits for services including storage, machine learning, AI and other analytics services. 

So what? Amazon’s initiative is not the first aimed to support IT infrastructure for researchers and health systems. Microsoft recently announced that it will roll out its Microsoft Teams service to NHS staff for free in order to streamline communication across colleagues in England and Scotland. The NHS’ digital transformation group, dubbed NHSX, also launched a program named TechForce19 to provide £500,000 in funding for innovators developing digital solutions for individuals in self-isolation. These initiatives continue to provide opportunities for digital health to increase its impact in the face of COVID-19. 

Funding and M&A
Headlines curated weekly by DeciBio's digital health team
Chris Lew
Senior Associate
Fanny Anderson
Associate
Tina Wang
Senior Analyst
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