At the proposed $1,000 price tag, Biomeme’ mobile clinical laboratory device has the potential to challenge diagnostic systems used in central laboratories
Another smartphone gadget capable of performing diagnostic laboratory tests is headed for the marketplace, and only time will tell if it proves to be a threat to the in vitro diagnostics industry.
Developers say that, when paired with a smartphone, this diagnostic device is similar to traditional medical laboratory technology 10 times its size. Called Biomeme, it is a system that diagnoses diseases like a clinical laboratory—but is just the size of a can of cola. It can identify DNA signatures of bacteria or viruses in a sample of saliva, blood or urine, according to a story that appeared in the Philadelphia Inquirer.
Biomeme’s Diagnostic Test Kit Works with a Smartphone
The system consists of diagnostics hardware, a sample prep kit, and a phone docking station. The hardware connects to the smartphone via the Bluetooth slot. The sample prep kit, which is sold separately, contains test tubes and freeze-dried chemicals. Color-coded for ease of use, these chemicals breakdown cells and and purify the genetic material inside.
Inside the chassis of the Biomeme gadget is an Arduino. This is an open source electronics prototyping platform. Arduino can adjust the machine’s temperature with heaters and fans. It controls the excitation light and handles the wireless connection with the iOS device, noted a report published by TechCrunch.com.
Biomeme Utilizes Traditional Medical Lab Diagnostic Technology
After loading a sample [blood, saliva, or urine] into the top of the machine, the user waits while the system processes the results. The Biomeme system processes samples utilizing quantitative polymerase chain reaction (qPCR) to look for a specific segment of the sample’s DNA, such as that of a flu virus. If present, the Biomeme system makes copies of it using enzymes that react with repeated heating and cooling cycles, wrote the Philly.com reporter Meeri Kim.
“qPCR is essentially a photocopier for DNA,” observed Jesse vanWestrienen, a Cofounder of Biomeme. “You can go from one copy of DNA to billions.”
By attaching the DNA to a light-emitting molecule, Biomeme uses the smartphone camera to monitor the reaction in real time, he noted, explaining that if the camera detects more light as more copies are made, the sample is positive for flu virus, but if it stays dark, that means this virus was never present. After about 40 cycles, enough DNA snippets are copied to make them easy to detect.
How Developers Kept the Cost of the Biomeme System at $1,000
Next, Biomeme utilizes the smartphone’s processor to run raw the data through algorithms. When finished, the smartphone uses the wireless or cellular connection to send the results to cloud storage, along with a GPS-tagged location.
“All of those are elements we don’t need to include in our hardware,” added Max Perelman, another Biomeme Cofounder.
“They are elements that Apple and Samsung are experts at, and why not piggyback on that?,” he continued, noting that, by utilizing components from the smartphone, developers were able to keep the cost of Biomeme at $1,000.
Launching the Biomeme Startup on a ‘Shoestring’
Beginning in April, cofounders Perelman, vanWestrienen, and engineering guru Mac DeJohn, pulled up stakes in California and New Mexico to participate in DreamIT Health Philadelphia, a four-month boot camp aimed at accelerating launch of technology start-ups.
They received $50,000 in initial seed capital and free office space from a partnership of DreamIt Health, Independence Blue Cross (INDBLUP), and Penn Medicine to launch Biomeme. Since then, the cofounders raised more than $1 million from a mix of crowdfunding and large investors to launch Biomeme. The startup is now a full-time resident at NextFab Studio, a manufacturing hub consisting of entrepreneurial enterprises ranging from electronics labs to 3D printers.
Dexel College of Medicine to Test Drive Biomeme on Human Samples
Next year, the company, in collaboration with the Drexel University College of Medicine, will launch its first human studies. The study will use urine from patients with and without gonorrhea. Data from this study will be compared with results from diagnostic lab equipment. If the study proves successful, the Drexel physicians will test drive Biomeme in the women’s health clinic to get rapid diagnostic results for sexually transmitted diseases, which generally takes several days, noted the Philly.com story.
Biomeme Device Already is Attracting Potential Customers
At the proposed low cost, the founders of the Biomeme system hope that it could provide medical clinics, physician practices, and medical facilities in remote, third-world locations an inexpensive alternative to ordering diagnostic tests from a clinical laboratory, with the added benefit of getting accurate test results immediately.
Customers most interested in the Biomeme system so far, however, are the military and certain public health institutions. In the case of the U.S. Army Medicine and Air Force Medicine, their interest is in using the device for biothreat detection in the field.
Developers Plan to Offer the Biomeme to Consumers
Ultimately, the Biomeme principals plan to market the gadget to the consumers. “We want to spread biology to the population just like a “meme” [a term for any idea that goes viral], to empower consumers and patients,” Perelman told Philly.com. “If we can get the cost of goods down very low, it will be affordabe very soon for everyone.”
This is not the first smartphone lab test gadget developed with consumers in mind. uCheck is a smartphone device developed by Biosense. It can test urine for up to 25 different diseases. (See Dark Daily, “New iPhone App Allows Consmers to Test Their Urine on the Go for as Many as 25 Different Diseases,” April 26, 2013.)
In a separate project, Swiss researchers are developing a smartphone-based coagulation test that would allow patients on anticoagulation therapy to self-test at home, (See Dark Daily, “Swiss Researchers Developing a Smartphone-based Coagulation Test to Help Patients on Anticoagulation Therapy to Self-Test at Home,” June 9, 2014.)
Smartphone-based Diagnostic Tools to Challenge Lab Professionals
Smartphone apps available today are capable of monitoring key vitals, like blood pressure heart, temperature and blood oxygen. Next-gen devices, integrated with smartphones, are on the way and will have the capabilities to perform more complex diagnostics.
As this happens, pathologists and clinical laboratory scientists will be presented with some interesting challenges.
Not the least of these challenges will be to demonstrate whether or not these devices can provide accuracy and reproducibility comparable to traditional medical laboratories analyzers. As well, it can be expected that the FDA will have something to say about the use of smartphone-enabled diagnostic tools for clinical diagnostic purposes.
—By Patricia Kirk
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