Maverick Detection System (Image credit: Genalyte)
The San Diego-based startup leverages lab-on-a-chip technology it says can run through up to 128 different tests on a single finger prick of blood in under 15 minutes using what it calls its Maverick Detection Platform.
Genalyte’s proprietary silicon chip contains arrays of photonic microring sensors to detect diseases like rheumatoid arthritis and the startup hopes to use this technology in an outpatient setting, pending FDA approval.
Genalyte has already gained permission from an Institutional Review Board (IRB) to runclinical studies aon the accuracy of its finger prick technology against whole blood testing techniques and plans to use the new funding to run more clinical trials in the near future to gear up for possible regulatory approval.
So far, CEO Cary Gunn says those tests, which were presented at the American College of Rheumatology (ACR) annual meeting on November 12, have yielded positive results and the company is now ready to take it’s technology to the next phase.
Genalyte’s technology is already used commercially in the pharmaceutical industry but, as mentioned, Gunn wants to move it to a “near-patient” setting where doctors can run diagnostics on a prick of blood right at their practice and get the results within minutes, as opposed to sending patients out to a lab and having them wait a few days for results.
This is somewhat similar to Theranos’s original plan when it worked with former partner Walgreens. In theory, patients would go to a Theranos lab within Walgreens, give a finger prick of blood and get results on an app later that day.
However, the industry is skeptical — especially in light of Theranos — and Gunn says he plans to avoid the many missteps of its competitor with a bevy of clinical trials to ensure the technology works before releasing the technology to consumers. The company has already published its findings in scientific journals — something Theranos did not do. It was also started by those with a medical background and involved the medical community from the beginning — another thing Theranos was criticized for not doing.
“[The industry] wants to see data. They want to see studies done and they want to see results and that’s the way we are engaging with them and that’s something that takes time,” Gunn says. “It’s not always the sexiest thing for the print media.”
While some believe the beleaguered Theranos was our only hope for a breakthrough in blood diagnostics (and that the press ruined any prospects of progress in this endeavor), Genalyte and others like it show promise in the field.
“The diagnostics industry is on the cusp of a sea change and Genalyte is the standard bearer in an effort that will transform not only diagnostics but how precision medicine is practiced,” head of Khosla Ventures Vinod Khosla said of his investment. “At Khosla Ventures, we’re proud to expand our partnership with a firm that has and continues to demonstrate a commitment to a rigorous scientific process in order to provide timely and accurate access to diagnostic and health data.”