91.1 F
San Fernando
Thursday, Mar 28, 2024

Cancer Startup Preps for Test

Biopsies to monitor the progress of patients with cancer can often be painful, and in the worst cases, lead to death from complications. Now, a Thousand Oaks startup is close to commercializing a diagnostic test that could revolutionize the procedure – and it’s done so on just $10 million in funding. Cynvenio Biosystems Inc. has developed a test that separates cancer cells from the blood, eliminating the risk that comes from invasive biopsies. Dubbed the “liquid biopsy,” it also is supposed to help doctors better monitor treatment. The company completed a $3 million funding round last year from its private investors, and is now moving to secure federal approval so the procedure can be tested by more cancer centers. “We’ve been able to do it with just about $10 million,” said Paul Dempsey, vice president of bioengineering, research and development. “Now we’re focused on making it more scalable and cost-effective.” Cynvenio’s primary product is a diagnostic test that separates cancer cells from blood, done by its in-house labs using proprietary machines. Not only is the procedure safer than traditional biopsies, but the company says it can detect cancers in areas of the body where traditional biopsies do not work, such as the stomach. The company secured several million dollars in grant funding from the National Cancer Institute last year, and has an undisclosed number of private investors, from whom it raised the $3 million in November. The race to improve on biopsy tests has attracted some big names, given the amount of money that an effective new test could generate. Other companies working on liquid biopsy methods include a New Jersey company backed by Brunswick, N.J. pharmaceutical giant Johnson & Johnson. In short, there is a race on to get the tests into the hands of doctors. David Yang, a biotechnology industry analyst with Santa Monica firm IBISWorld, said that companies with backing by the likes of Johnson & Johnson may have an advantage. “On average, there are more companies partnering with pharmaceutical companies, because it gives them more secure funding for their research,” he said. Research partners Cynvenio was founded in 2007 as a spin-off of Santa Barbara biotechnology company CytomX LLC. Its technology is licensed from the University of California, Santa Barbara. The liquid biopsy system uses a diagnostic machine to isolate cancer cells out of blood which are then placed onto a small glass “chip” to be analyzed. The company already has partnered with a limited number of cancer centers including Memorial Sloan-Kettering in New York; Fox Chase Cancer Center in Philadelphia; and the University of Chicago Cancer Research Center, which are using the laboratory services in internal research and clinical trials. However, it is still awaiting approval from the Centers for Medicare and Medicaid Services, a federal agency within the U.S. Department of Health and Human Services for what is called Clinical Laboratory Improvement Amendments certification. That will allow the company to expand its testing to other sites. “This is being done through clinical partnerships with national cancer research centers,” said Andre De Fusco, chief executive of Cynvenio. “The tests and results will be available to clinical partners and doctors working with them, and to the patients that have joined clinical trials.” Assuming the test results are positive, the company will seek approval from the Food and Drug Administration later this year to market its tests for breast, prostate and lung cancer. About 50 to 80 samples a month are currently being analyzed in the company’s lab, said Dempsey, who expects that number to grow after its certification. Each test ranges from $1,250 to $9,500 in cost, depending on the level of analysis requested. The company also founded a subsidiary, Biomolded Products LLC, in December 2011, which manufactures parts for the company’s lab tools and for other biotech firms in the area. The subsidiary, which shares space with the main company, makes tiny plastic parts needed for the machines that separate the cancer cells from blood and for the kits doctors use to collect the blood. It also makes parts for Camarillo biomedical device company Kinamed Inc. Attorney Brent Reinke, a partner at Westlake Village firm Musick, Peeler & Garrett LLP, who specializes in startup acquisitions and venture funding, said the way the company is slowly rolling out its product has put them in a unique position. “If they can get doctors and research individuals to use it and think that it’s valuable, then that’s going to help them attract investors down the line if they need them,” he said. “Until you have customer validation, you’re just selling your word.” Race to market While most of its analysis up to this point has been working with limited clinical trials, the company says its CLIA certification will allow it to begin marketing the product to a wider audience. It plans to seek full FDA later this year, which could take some time, although Yang, the analyst, says that the company could benefit from new provisions of federal health care reform as it seeks regulatory approvals. “With the act, there are clearer regulations with biotech patent laws,” he said. “And because of that, the act is really promoting new ways to get more efficient treatments.” Meanwhile, Veridex LLC, the firm backed by Johnson & Johnson, received FDA approval for a device used with its liquid biopsy system two months ago, and has been securing international approvals, including clearance in China. Cynvenio officials, however, claim its technology goes a step farther than CellSearch. Most liquid biopsy methods still only do analysis on the number of cells in a blood stream, which are traditionally indicative of cancer recurrence. In contrast, Cynvenio’s system can differentiate the type of cells, according to Dempsey. This allows doctors to see if any mutations have occurred and treat the cancer accordingly. “They are still just counting cells,” said Dempsey. “But what they’ve done is shown us these cells are related to the disease.” Calls placed to Veridex for comment were not returned. Company officials say moving forward with sales of its blood sample kit and launch of its research tools for cancer centers and pharmaceutical research is a huge step forward. Doctors, pharmaceutical company R&D departments and other researchers will soon be able to buy sample-collection kits, which include a vial for blood and two chemical additives that allow the blood to be shipped without refrigeration. The protocol calls for the samples to be shipped to Cynvenio’s lab, where several stages of separation and analysis take place. Depending on the clinical orders, either the results of mutation analysis or the samples prepped for other research will be shipped back. However, it is far from certain that insurance companies will want to cover the new test. Currently, the cost of a breast biopsy ranges between $1,000 and $5,000, while the cost of full analysis with liquid biopsy is much higher currently. Dempsey said the company is working toward lowering the cost and, ultimately, thinks it will work. “There is a very clear incentive for pharmaceutical companies, doctors and insurance companies to know how to effectively treat cancers,” he said.

Featured Articles

Related Articles