One of the primary tenets of the Patient Protection and Affordable Care Act, known affably as Obamacare, is to lower the uninsured rate and open avenues for consumers to get proper preventative care. Detecting risk factors for chronic diseases early, or beginning treatment on a chronic disease early, can improve patients' quality of life, extend survival, and keep long-term healthcare costs for the consumer and insurer lower than the alternative of rarely (if ever) going to the doctor.
Yet, when push comes to shove, Americans (including me) have a laundry list of excuses for why they don't go to the doctor. For some, it's the cost, while others simply don't have the time. However, one of the top three reasons Americans avoid the doctor is because they're scared, either to be judged by their physician or to divulge their prior health history! As for me, I'm not shy about the fact that I'm a bit of a needle-phobe, so I have a different type of fear.
However, a new device being developed by a small, privately held Wisconsin-based company could be on the verge of revolutionizing how your blood is drawn for clinical testing.
Fear no more
According to recently-released materials from the University of Wisconsin-Madison, and as published in Science Daily, device maker Tasso could be on the verge of getting its game-changing blood test approved by the Food and Drug Administration.
The device, known as HemoLink, is "about the size of a pingpong ball" and is capable of extracting 0.15 of a cubic centimeter of blood in about two minutes. This is the standard amount needed to test cholesterol levels, blood sugar, or detect the presence of cancer cells or infection. The user simply holds the device up to the skin, whereby a slight vacuum is created, channeling your blood flow into sample tubes that are then mailed by the user to the lab for analysis. Initial users have described the process as being virtually pain-free.
For its part, the Defense Advanced Research Projects Agency gave Tasso $3 million to advance HemoLink in an effort to stabilize its blood samples at 140-degrees for a week. It's also received funding from the National Institutes of Health to develop a technique that'll allow its blood draw devices to help diagnose HIV.
Ultimately, Tasso believes its device could shorten doctor's office lines by removing visits primarily for blood work, and it could allay fears for people (like me) who are terrified of blood draws.
Another important aspect of HemoLink is that it's relatively cheap and easy to produce. It consists of just six injection-molded components that allows for quick and cheap assembly.
Where isn't HemoLink going?
According to its principle developers, there aren't any plans currently in the works to develop HemoLink for frequent blood draws users, such as diabetics. While the test can be used to test for a patient's blood sugar as the basis for a routine checkup, diabetics are frequent users who'll continue to rely on the current standard of testing. HemoLink is directed primarily at semi-frequent or infrequent blood draw users.
Tasso currently plans to file a marketing application with the Food and Drug Administration later this year and, with an approval, could reach the market as soon as next year.
A focus on convenience
Investors may not be able to buy into the Tasso story (at least as of yet), but what it goes to show is that the push toward convenience and personalization is only increasing in the medical field. Researchers realize the easier and more pain-free they can make a process for the consumer, the more likely the consumer is to take action.
Take, as a great example, the August approval of Exact Sciences' (NASDAQ:EXAS) Cologuard.
Cologuard is a noninvasive DNA screening test for colorectal cancer. It's designed to allow a patient to send a stool sample collected from the comfort of their home into Exact Sciences' laboratories. When it reaches the laboratory, Exact Sciences analyzes the patient's sample for abnormal DNA based on cells shed from the wall of the patients' colon. If any abnormal DNA is detected, the next step for the patient would be to get a colonoscopy.
In clinical testing, Cologuard correctly identified 92% of all colorectal cancers and 42% of advanced adenomas, or precancerous polyps. While that's not perfect by any means, it's a great starting point for colonoscopy-fearing adults. Plus, it's been cleared for coverage by the Centers for Medicare and Medicaid Services, meaning it's the perfect diagnostic tool for Medicare-covered seniors to take advantage of.
Another example of a breakthrough in convenience is Medtronic's (NYSE:MDT) MiniMed 530G.
Approved in 2013, the MiniMed 530G was the world's first artificial pancreas system, capable of pumping insulin into a diabetic patient and using attached sensors to determine when to shut off after reaching desired glucose levels. This type of pump should greatly reduce instances of hypoglycemia (low blood sugar), and it removes the guesswork of when to medicate for the diabetic user. A recently-developed model approved in select overseas markets now comes with a color screen and can be submerged in up to 3.6 meters of water for up to 24 hours.
We're also seeing convenience spill over from just medical devices and diagnostics into the actual drug delivery realm.
MannKind's (NASDAQ:56400P706) recently-approved drug Afrezza is an inhalable diabetes product that could eliminate the need to inject yourself with insulin. With the exception of mild side effects, such as a possible cough, the inhalable powder proved to be non-inferior to existing diabetes medications, and it was particularly effective in its ability to leave the body quicker than previous standards of care. This last point is particularly important as it mimics how insulin should behave in your body and greatly reduces the chances of developing hypoglycemia.
Personalization: Coming to a doctor near you
I'm very excited for what Tasso may have to offer, but I view Tasso's early success more as a reminder that nearly all medical device, diagnostic, and drug developers are focused on improving patient convenience. We're seeing more medications pushed into oral formulations that were previously intravenous only, and we're also witnessing a surge in at-home diagnostic exams meant to encourage consumers to take action.
These are exciting times, and it pays for consumers and investors to stay abreast of the latest drugs and devices readying to hit the market. What will they think of next?
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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