HEALTHCARE CONSUMERS LOOKING TO SAVE MONEY

• According to research by the Federal Reserve, 40% of Americans cannot cover a $400 emergency should the need arise.
• This coupled with the fact that more "employees are opting for high deductible plans offered by employers, which means they’re paying more out of pocket for medical expenses," makes many patients see home testing as a way to avoid seeing the doctor, and hence reducing their health care cost.
• Home testing allows them to proactively test for specific conditions.
• Moreover, patients rarely have insights into how much these tests may cost when they visit the hospitals. This lack of transparency also influences consumer behavior in opting for at-home tests.
• The "rising costs of insurance combined with increasing deductibles and personal obligations to pay" is also another contributory factor in consumers' increased adoption of at-home medical tests.

• There has been a shift in mindset, where patients no longer see themselves as just patients, but as health consumers/customers.
• The catalysts for this shift include immediate access to data and information, access to do-it-yourself technology, the cost and complexities of the healthcare system, as well as the plethora of health-related communities that patients join to socialize and aid in their research of answers.
• All the aforementioned factors precipitate a growing culture of consumer empowerment, where customers are not passive about their health to being empowered to take charge and action on their health without the encumbrances of cost and access.
• For example, the "inherent accessibility of DTC-GT is a major benefit, allowing consumers free access to their own genetic information and access to personalized insights and recommendations."

• On the other hand, retailers are shifting gears and trying to augment their revenue from healthcare and are evolving as an alternate channel to deliver care, including the "sale of home diagnostic tests as well as monitoring and wellness plans."
• Larry Merlo, the CEO of CVS Health, notes that retailers such as Aetna and CVS are evolving into a more comprehensive healthcare destination than just a store for selling drugs and related products.
• The inference from the above is that retailers are investing more into direct to consumer medical tests, which will, in turn, spur innovation and provide more options for consumers across different conditions. For example, CVS announced that "it plans to disrupt kidney care by expanding home dialysis, identifying kidney disease earlier and developing new home hemodialysis technology."

REGULATION

• Despite the many brands of DIY health tests, healthcare professionals are concerned that these testing kits are not regulated.  
• As it stands, there is no regulatory body that looks at the quality of these products. Therefore, there is significant variability when it comes to the test results from different brands.
• Since at-home tests are not regulated by the FDA, many professionals are concerned about how patients act after viewing the results. For instance, patients could overreact to results and self-medicate without proper consultation, which could pose a risk to their health. In addition, the tests could make users seek medical care that is not necessary.
• In addition, due to the lack of regulation, companies that produce these kits can sell them at their preferred price, which can sometimes be costly to customers especially if they are paying out-of-pocket.

CLINICAL VALIDATION

• Healthcare experts are concerned that some at-home tests are not clinically validated.
• A study conducted by healthcare experts revealed that 40% of variants found in raw DNA data from at-home genetic tests were false positives after retesting them in a clinical lab. These false positive can result in patients experiencing stress and anxiety.
• DIY health tests do not go through thorough lab analysis. These tests only look at a few gene variants, which could lead to inaccurate results. Moreover, some kits employ testing methods that are medically questionable.
• Since these tests are not validated, experts believe that they can misdiagnose the conditions of patients. Furthermore, experts claim that the test results cannot be compared to the insights provided by a doctor who is familiar with a patient’s history.
• For instance, the American Academy of Allergy, Asthma & Immunology (AAAAI) noted in its website that IgG tests that are used to diagnose food sensitivity have never been clinically validated to show that they are effective.

RESEARCH STRATEGY