Is There a Diagnostic Company to Rise From the Ashes of Theranos?
Theranos, founded by Elizabeth Holmes, raised more than $700 million from investors from 2013 and 2015, part of what the U.S. Securities and Exchange Commission (SEC) called “years-long fraud” in which it lied or exaggerated about its diagnostic technology and the state of its finances. Both Holmes and former company president Sunny Balwani have been charged with massive fraud by the SEC.
The company’s technology, which was never peer-reviewed, claimed to be able to provide laboratory testing on a single drop of blood at a far lower cost. Eventual investigations of the company and its Edison devices found the company was not actually using the devices, but standard laboratory equipment, and often in an inaccurate fashion.
But companies are filling in the gaps and the entire area of so-called “liquid biopsies” is hot these days, with companies like Guardant Health, Karius, Freenome, Apostle and GRAIL entering the market. With this backdrop, let’s look at some companies working in the same field as the now-defunct Theranos.
Ativa Medical. Based in St. Paul, Minnesota, Ativa Medical is working to develop an affordable diagnostic product that consolidates blood testing to decentralized healthcare settings. The company is developing the Ativa MicroLab, which can process diagnostic tests on small blood or urine samples. It uses a single-use test cartridge that is projected to cost about $8 per test. As of now, the system is not cleared for use in the U.S.
In an article about Ativa in the Star Tribune, Kathleen Tune, managing director of Minneapolis’ Fourth Element Capital, said, “This technology—the concept—is amazing. I think that’s why people were willing to go down that road with Theranos. But I’m sure [Theranos’ collapse] did cause a taint on the technology area.”
Genalyte. Headquartered in San Diego and Austin, Texas, Genalyte is developing a portable laboratory that can run about 62 different clinical tests on just a few drops of blood. It is called the Maverick Detection System and uses microchip tech to analyze multiple antibodies and other proteins. It then digitizes the samples and sends the data to a cloud-based laboratory for review, then sends results to the physician in real time.
Quick to separate itself from Theranos, the company draws on larger blood samples of about 10 microliters and is focused on the rheumatology market. Last year the company launched a pilot program with six clinics in San Diego. The goal is to prove that patients prefer the system and that it can decrease physician error.
Abbott Laboratories. Wait, what? Yes, Abbott is actually the 5,000-pound gorilla in the field of point-of-care diagnostics. Its i-Stat is found in about a third of all U.S. hospitals. i-Stat is a handheld device. Drops of blood are placed onto an SD-card-like cartridge that slides into the device. The test results are uploaded wirelessly and automatically. It can run about 26 different tests via different cartridges.
“You can run the blood and get results in 10 minutes,” Narendra Soman, director of R&D for point-of-care diagnostics at Abbott told Wired. “That happens right at the patient’s side, as opposed to having to draw blood and send it to a lab.”
Athelas. Located in Mountain View, California, Athelas is working to develop a rapid blood diagnostics and immune monitoring platform that could be used at home by chemotherapy patients, in addition to pharmaceutical companies. Its technology uses deep learning and computer vision to analyze high-resolution blood images in order to generate cell counts. Reportedly, the device is able to test for the flu, bacterial infections, and some cancers. At the moment, it is predominantly used to monitor white blood cell counts for chemotherapy.
Karius. Based in Redwood City, Calif., the company is working on the Karius Test, a comprehensive device capable of identifying more than 1,000 pathogens directly from blood. It uses next-generation sequencing technology to analyze microbial cell-free DNA. The company’s laboratory is both CLIA-certified and CAP-accredited to perform high-complexity clinical lab testing.
On December 12, 2018, Karius, along with investigators from the University of California San Francisco, published a study showing the effectiveness of the Karius Test in monitoring infections in stem-cell transplant patients.
“We often struggle to make a diagnosis in patients with stem cell transplants,” stated Monica Fung, first author of the study, a researcher with UCSF, at the time. “Their infections don’t manifest with the typical symptoms you see in healthy individuals. What is exciting about the Karius Test is its ability to test a really broad range of pathogens quickly.”
Orphidia. Located in San Francisco, but originally out of London, UK, Orphida is working on a portable device, the Orphidia Portable Lab Analyzer (PLA), that can run 40 common diagnostic tests from a drop of blood, with results in 20 minutes. It uses microfluidic chips to test via automation. It also uses cloud technology to receive tests data immediately from the technology, where it is stored and made available to physicians.
It’s important to remember that, in the wider world of clinical diagnostics, these devices are very limited. There are more than 4,000 different diagnostic tests available, with the two largest clinical diagnostics providers in the U.S., LabCorp and Quest Diagnostics having test menus that offer thousands of tests. Still, there is a huge need for faster, cheaper and more efficient tests that can be performed at the bedside, in developing countries, or in emergency situations.