On-Q-ity is betting that it can help improve cancer research and treatment by spotting the rarest of tumor cells circulating in the blood. Now the startup’s technology has found an important new benefactor in Laboratory Corporation of America (NYSE: LH).
Waltham, MA-based On-Q-ity is announcing today it has formed a strategic alliance with LabCorp in which the big research and diagnostics player will use its sales, marketing, and distribution muscle to commercialize On-Q-ity’s technology for detecting circulating tumor cells. LabCorp will pitch the technology to cancer drug R&D operations that want to do a better job recruiting the right patients into clinical trials, seeing quickly whether a new drug is working, and finding out early when patients are relapsing. Financial terms of the deal aren’t being disclosed.
“I am thrilled about it,” says Mara Aspinall, the CEO of On-Q-ity. “LabCorp has the ability to get this to researchers around the world, to small and large companies, to people in the process of putting together some of most important clinical trials for cancer. This is the first big step in making the technology broadly available.”
The LabCorp deal is clearly important for a fledgling technology developer like On-Q-ity, which formed in 2009 through the merger of a pair of startups. The On-Q-ity technology is supposed to be able to go a step further than the traditional diagnostic tools of oncology. It’s intended to find cells from tumors that are so small and rare they don’t yet show up on today’s most high-resolution CT and MRI imaging tools. Scientists hope that by using this kind of tool—which spots cells in blood samples that can be take repeatedly over time at a relatively low cost—they’ll have a rich new set of data to track how cancer spreads over time. Eventually, treatment regimens could be made more personalized by seeing in real-time whether a patient responds to treatment, or not.
The On-Q-ity technology has so far only been tested by a small group of beta users, and today’s deal with LabCorp means that it will get its first big shot at widespread usage. The hope is that by refining things like inclusion and exclusion criteria for clinical trials, and by determining more quickly when a malignancy has spread, that drug developers will be able to increase their odds of success with developing new medicines, Aspinall says. It’s a huge need for an industry in which more than 800 cancer drugs are said to be in development, an only estimated one out of 10 will be good enough to make it through all the necessary clinical trials, and where success is often defined as a drug that actually helps only about one out of every four patients.
By going first into the R&D market, On-Q-ity can start generating product sales early in its life, without waiting for what could be a time-consuming and expensive process of seeking FDA approval in a more regulated application like clinical diagnostics. The company also has its sights set on entering the diagnostics market, Aspinall says, but R&D makes sense as an initial market partly because it will give top researchers a sense of what else they can do with the tool later on.
On-Q-ity certainly isn’t the only company seeking to commercialize an instrument that spots circulating tumor cells. Veridex, a unit of Johnson & Johnson in North Raritan, NJ, has an FDA approved instrument for spotting circulating tumor cells. On-Q-ity, Aspinall says, is hoping it can establish a technical advantage through its system, which analyzes circulating tumor cells with a dual mechanism that looks at both their size and the affinity with which they bind to certain antibodies.
The deal with LabCorp isn’t actually much of a surprise—Aspinall is no stranger to the folks there. She is the former president of Genzyme Genetics, the diagnostics unit of Cambridge, MA-based Genzyme (NASDAQ: GENZ) that LabCorp agreed to acquire in September for $925 million. Andy Conrad, the chief scientific officer of LabCorp has been “very aggressive” in making sure LabCorp stays on the cutting edge of new technology, Aspinall says. She says she has confidence that LabCorp will perform well with Genzyme Genetics—“it’s my baby,” she says—just like it will with On-Q-ity.
If the circulating tumor cell technology catches on, it will be part of what sounds like a dizzying array of technologies for diagnosing and monitoring cancer. Researchers will still use ever-more powerful images of tumors from CT and MRI, combined with the circulating tumor cell information from the blood, plus more DNA analysis of tumors as gene sequencing gets continually faster and cheaper. I asked Aspinall whether all this information might lead to false alarms, and over-reactive treatment regimens, especially with a slow-growing malignancy like, say, prostate cancer, which is thought to linger for years in many men without causing much harm. The objection certainly isn’t new. That’s partly why Aspinall says On-Q-ity is positioning its technology in cancer trials, among existing cancer patients, instead of pitching it as a broad cancer screening tool like the PSA test is for prostate cancer.
“My career has been about asking what is the greatest need for patients? The greatest need for patients today is in increasing the efficacy of treatments available now,” Aspinall says. Cancer drug regimens only work about one-fourth of the time, and that’s unacceptable, she says. “We’ve made such progress with new drugs, we need to use diagnostics to improve the information the physician has if we want to improve how we use those drugs.”
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