Microdrop Blood Testing Device is Validated by Scientific Community
These days, when someone mentions blood-testing diagnostics systems that rely on a few drops of blood, first thoughts may head directly to the alleged fraud committed by the founder and chief executive officer of Theranos, Elizabeth Holmes.
Homes faces up to 20 years in prison for allegedly defrauding investors at Theranos. For years Holmes promised a diagnostic technology that could function on a single drop of blood but never delivered on her promises. All the while, the company raised hundreds of millions of dollars from investors and the diagnostics that were performed, led to numerous lawsuits over the tens of thousands of results that had to be voided.
But despite that background, the co-founders of Microdrop believe they have a blood-testing diagnostics system that will bring levels of confidence back to the space due to validation from the scientific community.
“We’re working hard to be different,” Jani Tuomi, co-founder of healthcare company Microdrop, told BioSpace in an exclusive interview.
Microdrop has created a direct-to-consumer product that uses several drops of blood to test for several medical conditions, including celiac disease, rheumatoid arthritis and other diseases. The company’s device, called imaware, is the first at-home blood-testing platform to validate and share its data with consumers and medical professionals. For Theranos followers, some of that information may sound familiar, but unlike the company that closely guarded its proprietary information (what little there may actually have been), Microdrop is being quite open about its data. The openness, as well as the efficacy of the imaware diagnostics, has brought the product some significant support, including from Beyond Celiac, an advocacy group. The company recently shared data in an article in the clinical chemistry journals “Clinical Chemistry and Laboratory Medicine” that showed the imaware product achieved a 98.3 percent or higher report in levels of accuracy.
Consumers collect the blood at home in a small vial and send it to imaware for testing. Testing is conducted on imaware platforms at CLIA-certified partner laboratories located in Missouri and Texas. The results are then shared in a secure and private online portal with additional resources and access to local medical professionals.
The imaware test measures multiple biomarkers in order to provide the consumer with comprehensive results he or she can then take to their physician for further study, Tuomi said. As researchers continue to learn more and more about biomarkers for various diseases, Tuomi said it is likely the imaware test will be able to expand the range of diseases and conditions it can test for. Microdrop anticipates expanding its imaware testing for cardiovascular health, liver disease and prostate health later this year. He said the “menus of tests” the company will offer this year are “pretty impressive.”
Tuomi said that at-home testing is a valuable tool for people who want to take control of their health care and stay in front of any potential concerns they may have. But, he said the issues of Theranos and its invalidated tests and disgraced research has made people wary.
"The missing piece in at-home testing has been transparency in how the tests work and their accuracy,” Tuomi said.
Additionally, Tuomi noted that for every indication that the imaware tests, they have well-known medical specialists from those areas of study involved who validate the tests as well as author papers. As a point of reference, Tuomi said one of the specialists involved with the celiac tests is the researcher who identified the biomarker for the autoimmune disorder.
“We partner with leading specialists for each condition we test for. We will never launch a test we can’t have leading specialists be on board with for validating,” Tuomi said. “We are putting all of our data where our mouth is.”