The advent of high-throughput DNA sequencing has greatly accelerated biomedical research and discovery, and brought the cost of sequencing a whole human genome to roughly $1,000.
But what if you don’t need the whole genome?
Carlsbad, CA-based ChromaCode was founded in late 2012 with the idea of boosting old-school molecular diagnostics instruments used in clinical diagnoses. With technology licensed from the California Institute of Technology, ChromaCode enhances the results of the industry standard real-time polymerase chain reaction (PCR) machines. Instead of showing results for four or five genetic biomarkers, though, ChromaCode says it “multiplexes” the process to measure 20 or more biomarkers.
ChromaCode (named as an Xconomy San Diego 2016 Life Sciences Startup to Watch) said last week it has raised $12 million in Series B funding, bringing the company’s total funding to $14.6 million. New Enterprise Associates led the round, which was joined by existing investors Domain Associates and Okapi Ventures.
The company also named former Illumina senior vice president Alex Dickinson as executive chairman. (All eight current employees are in the photo above, and Dickinson is at the top right.) Dickinson, who left Illumina in January, said in a recent interview that he founded ChromaCode with CTO Aditya Rajagopal, who invented the multiplexed PCR assay design, data processing algorithms, and other core technologies while working on his doctorate at Caltech.
“I was there from the start, wrote the business plan, named the company, even designed the logo,” said Dickinson, who added he’s now working “day to day” at ChromaCode.
“Next-generation sequencing often gives you more information than you really need,” Dickinson explained. “Many applications don’t need the great number of biomarkers that whole genome sequencing produces.” On the other hand, he added, the five genetic biomarkers produced by standard real-time PCR machines is usually not helpful enough to be conclusive in many clinical diagnoses, such as chronic respiratory disease. Providing results on 12 to 20 biomarkers, though, is just right.
ChromaCode’s technology enables labs to conduct “multiplexed” tests on quantitative PCR machines that are already in use in molecular diagnostic labs. The company estimates there are 100,000 qPCR instruments worldwide.
The company plans to use the additional funding to commercialize its technology, dubbed “high-definition” PCR, and to fuel additional product development. “We used the Series A money to get from proof-of-concept to prototype and a regulatory-ready assay,” Dickinson said. “Now we’re going to take that $12 million and ramp up production.”
He also plans to hire more technical employees, software developers, and marketing executives, expanding ChromaCode’s staff from eight to 20 by the end of this year.
ChromaCode plans to introduce its technology at so-called “CLIA” laboratories that have been certified under state and federal regulations to conduct sophisticated diagnostic testing on human samples, Dickinson said. The company would work with these labs to validate its HDPCR technology.
Greg Gosch, who continues to serve as ChromaCode’s CEO, said the company has not yet set pricing, but it will be “significantly less” than running the same number of PCR tests individually, and “dramatically less” than next-generation sequencing—“tens of dollars versus thousands of dollars.”
The time and workflow required to process ChromaCode’s HDPCR technology also would be comparable to running a standard PCR test—about one hour—in contrast to the days typically required for next-gen sequencing, Gosch said.
In an e-mail, Gosch wrote: “Same-day results means physicians can apply appropriate, sometimes, critical therapy sooner. Consider a physician who is treating a patient with progressing cancer and needs the test result to determine which chemotherapeutic agent is appropriate. Also, researchers can make timely decisions regarding the next steps in their research plans and therefore dramatically improve their efficiency. Moreover, we can process up to 96 results in [about one hour], which means researchers can test many more samples in a given period of time, allowing them to expand their data set.”