Blood testing nears a turning point as the evidence becomes undeniable
Summary
Through different methods and modalities, these diagnostics promise to be a more accessible, less invasive, smarter, cheaper and a comprehensive way to gather knowledge about what’s going on under the skin—whether in a doctor’s office, at home or within a clinical laboratory. “In the end, I think what Theranos did do is that it created a shift in the market—where there are investors who say, ‘We’re comfortable diligencing technology, teams and regulatory strategies,’ and were willing to invest in our series B,” said Hawkins, who previously served as VP and general manager of Illumina’s reproductive and genetic health business. “They understand the path it takes to get from here to a product.” “And then there were other investors who—maybe from their takeaway from the Theranos time and thinking about their own capabilities—were saying, ‘No, we’re interested in what you’re doing, but we’ve decided as a fund to wait to invest in this space until a company makes a submission to the FDA,’” he said. At this month’s San Antonio Breast Cancer Symposium, Epic presented two research studies of people with metastatic or triple-negative disease, showing its technology could spot the underlying genomic biomarkers by observing the shapes, features and differences between cells. “But now the physicians are accepting, the data is supporting, and the FDA is approving…Its the culmination of things that were all happening disparately, and thats why this is going to take off in a big way.” “There are investors willing to deploy their capital into diagnostics,” said Hawkins, whose Truvian is also pursuing a CLIA waiver to get its device into the retail setting.
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