By Greg Reh, vice chairman, US and Global Life Sciences leader, Deloitte LLP

One of the earliest known at-home diagnostic tests dates back to Egypt in about 1350 BCE. It was a pregnancy test that relied on wheat and barley seeds, rather than a plastic stick, to make a diagnosis. In the early 1960s, researchers determined this ancient test would have been accurate about 70 percent of the time.¹

Fast forward 3,300 years to today as we head to AdvaMed’s annual medtech conference where the latest at-home diagnostics will certainly be a topic of conversation. We have entered an era where everything from a person’s ancestry to his or her complete microbiome can be deciphered from the genetic information contained on a cotton swab or in a drop of blood. A growing awareness about the health benefits of preventive care and early diagnosis is helping fuel demand for at-home diagnostic tools that can detect an array of illnesses and conditions. According to the Food and Drug Administration’s (FDA) website, home tests can be cost-effective, quick, and confidential. But the agency notes that such tests should not replace periodic visits to the doctor.

Consumers are becoming comfortable with DIY medical tests
Consumers are increasingly open to new channels of care—particularly at-home diagnostic testing, according to the results of our new survey of health care consumers. About half of this year’s survey respondents said they are comfortable using an at-home test to diagnose infections (e.g., strep throat and urinary tract infections) before going to the doctor for treatment. Nearly as many—45 percent—said they would consider an at-home genetic test to identify existing or future health risks, and 44 percent are comfortable using an at-home blood test that connects to an app to track overall health trends, such as cholesterol, blood glucose, inflammation, and triglycerides. We also found that the number of consumers who use wearables to track their health data has more than doubled since 2013—and consumers have become more comfortable with sharing their data. Forty percent of health care consumers said they would share their health data with a device manufacturer if it helped improve the device.

Five conditions consumers could test at home
As at-home diagnostic testing becomes more accepted, medical-device manufacturers might have an opportunity to strengthen the relationship they have with consumers and their physicians. Increasingly sophisticated tools have the potential to improve health outcomes through faster diagnoses, 24/7 access to health coaching, and the ability to recognize mood and lifestyle changes that could affect adherence to a treatment plan. Moreover, DIY diagnostic tests could help low-income or rural consumers determine if a condition warrants a visit to a doctor or hospital.

Many device manufacturers are developing tools, tests, and apps along a continuum of wellness and prevention—ranging from acute diagnosis and chronic-disease management to identifying future risks of illness. Here’s a look at some areas where device manufacturers are innovating:

• Cancer: Last March, the FDA approved the first at-home diagnostic test that can detect three specific BRCA1/BRCA2 breast cancer gene mutations that are most common among Jewish people of Eastern European descent. The test was developed by the genomics and biotechnology firm 23andMe. In a press release, FDA noted that the test only detects three out of more than 1,000 known BRCA mutations. A year earlier, the agency gave the company permission to market its Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. DNA is collected on a cotton swab, which is swiped inside the consumer’s mouth, and mailed to the company for analysis.²
• Influenza: The Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services (HHS), recently announced that it is investing $24 million with two companies that are developing at-home flu tests. Cue Health will receive $14 million to develop a flu test that will be included in its in-home health monitoring technology platform. Diassess will receive $10 million to develop a single-use test (see the July 24, 2018 Health Care Current). With an at-home flu test, patients could use an app or device to send information to their physicians, who could then prescribe medication that can be delivered to the patient’s door. Patients would not have to leave their homes, which could help reduce the spread of the illness.
• Electrodariograms (EKGs): During a September 12 event, Apple, Inc. announced its latest Apple Watch^®* would include a EKG sensor that can alert the wearer to irregular rhythms.³Another company, AliveCor, has developed a remote monitoring device for arrhythmia (Kardia) that plugs into a smartphone and can conduct an EKG in 30 seconds.⁴ The user puts his or her finger on the device, which then transmits a reading directly to a physician. The physician can then track patterns and diagnose symptoms.
• Heart health: Cor⁵ measures heart health using a sample of blood and a connected app. The blood test measures cholesterol, fasting blood glucose, inflammation, and triglycerides. The app then provides insights based on trends and patterns in these indicators. It also provides diet, exercise, supplement, and relaxation recommendations.
• Microbiome health: Several companies—including Day Two Inc,⁶ uBiome Inc.,⁷ and Viome Inc.⁸—offer direct-to-consumer microbiome analysis. These tests provide personalized nutrition and behavioral recommendations tailored to the individual’s microbiome composition (i.e., the genetic material of the microorganisms that live in the gut). Some tests provide information about microorganisms associated with specific infections and metabolic disorders.

In ancient Egypt, physicians diagnosed their patients and recommended treatments based on observable symptoms. This level of care, however, was generally reserved for royalty and the wealthy. Today, many medical device manufacturers are developing a wide range of low-cost tools that allow anyone to assess their overall health status, or to identify a growing number of existing or potential illnesses. As these devices become more prevalent, clinicians should determine how to decode the information from these new data streams and use it to improve diagnoses, care, and outcomes. Partnerships between medical device manufactures (including EHR vendors) and providers could potentially help this effort.

Endnotes

* Apple Watch® is a trademark of Apple Inc., registered in the U.S. and other countries.

¹ National Institutes of Health, a Timeline of Pregnancy Testing. https://history.nih.gov/exhibits/thinblueline/timeline.html
² FDA press release, March 6, 2018 (https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm599560.htm)
³ https://www.apple.com/watch/
⁴ https://www.alivecor.com/how-it-works/
⁵ https://knowyourcor.com/
⁶ https://www.daytwo.com/
⁷ https://ubiome.com/
⁸ https://www.viome.com/

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