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Startup lab Theranos scales back unique 'finger prick' blood tests
Theranos, the $9 billion Silicon Valley startup that promises blood test results with just a finger prick, is under serious scrutiny. According to The Wall Street Journal, FDA investigators recently showed up unannounced to inspect its laboratory, due to concerns about the data the company voluntarily submitted for approval of its testing methods. So far, the FDA has only approved one (for herpes) of the 100 Theranos tests waiting for its endorsement. Since the agency also marked the "nanotainers" -- containers that can keep tiny amounts of blood -- Theranos uses as "unapproved medical devices," the company was forced to stop drawing blood by pricking patients' fingers unless it's to check for herpes. In short, it has almost completely stopped doing what makes the startup unique, making it like any other lab, with needles, syringes and such. Update (10/16): Founder Elizabeth Holmes had an interview with Jim Cramer on CNBC today (you can view it after the break), and Theranos has published another blog post promising "Unprecedented transparency." It confirms that the finger prick tests are only being performed to check for herpes, saying that it sought out and asked the FDA to review and fully clear its technology for other tests.
Lab-on-a-chip aims to take suspense out of blood work
If your doctor's ever uttered the words, "I'd like to run more tests," you know the wait for results can be torturous. Engineers and students at the University of Rhode Island (URI) are hoping to stop the torture with a new lab-on-a-chip technology that cuts way back on the wait for important lab results. The system provides results in 30 minutes, using a portable device and just a drop of blood. The blood is placed on a small plastic polymer cartridge, smaller than a credit card, and inserted into a shoebox-sized biosensor. It then travels across the cartridge to a detection site where reagents enable the sensor to detect biomarkers of disease. Basically, your doctor pops a bloody piece of plastic into a box, and out come your results. The first cartridges were developed to assess the risk of heart disease, but researches suggest they could be designed to detect everything from HIV to Alzheimer's. The URI team estimates costs at $3200 for the sensor and $1.50 for the test. No official word on a release date, but we hope they won't make us wait too long -- we can't stand the suspense.
