patients we’ve seen so far, their CTC trend has been really well coordinated with the clinical outcome.”
So far, Capio has conducted three clinical studies that together have involved 60-plus patients, Hong says. Many of them receive care at UNC Health Care in Chapel Hill, NC, near where Wang works.
Hong says that a typical patient is recruited upon receiving a cancer diagnosis, then undergoes a liquid biopsy, a minimally invasive blood test to look for cancer cells. Additional blood samples are collected after each round of treatment, he adds.
“If the CTC numbers go down, their response is typically good,” Hong says. “If the CTC numbers go back up, their response is not really good. That’s how we read their cancer progress.”
Capio, which only has two full-time employees but gets help from postdoctoral researchers who work in the co-founders’ labs, has looked at several different types of cancer; the list includes head and neck, renal, prostate, and lung. Currently, CellSearch is intended for use in patients with breast, prostate, or colorectal cancer, according to Janssen Diagnostics’ website.
Capio established a joint venture with Betta Pharmaceuticals that specifically targets lung cancer, in part because that disease is so prevalent in China, Hong says.
“The joint venture is to develop this technology in China for the Chinese market,” he says. “Betta has strong interest in non-small cell lung cancer targeted therapies. We see some synergy there.”
Meanwhile, in the U.S., Hong says Capio will continue to collect data from clinical studies, and he hopes the startup will be ready to apply for FDA clearance in two or three years.
Hong referred to OncoSense CTC as a “diagnostic device,” but says the company has not yet decided whether it will go down the regulatory pathway for a diagnostic, or the one for a medical device.
“It is a bit premature…to clearly state our strategies [regarding] the regulatory clearance process,” he says.
Capio also still has yet to determine which cancer OncoSense CTC will target first, but he says that after receiving its first FDA clearance in a cancer, regulatory nods for other forms of the disease would likely follow.
“But our technology is a platform technology, so we can expand to other types of diseases as well,” Hong says.
