Cellumen announced this week that it will spin out its personalized medicine unit into a separate entity to be called Cernostics Pathology. The new company will provide digital imaging pathology and tissue-based diagnostic products and services.
A Cellumen official told Cell-Based Assay News that Cernostics will build on Cellumen’s current collaborations, including its partnership with the Mayo Clinic and Foundation, to develop an advanced breast cancer diagnostic and theranostic test.
Since it was founded in 2004, Cellumen has been applying its cellular-systems biology approach across three core segments within the pharmaceutical industry: drug discovery, drug development, and clinical trials.
“We have applied that approach across those three domains, and we have received some strong interest and traction in all three areas,” said Don Taylor, senior director of marketing and corporate development at Cellumen. But “we decided that there are really two major opportunities: drug development, what we call discovery toxicology; and clinical trials, or patient stratification.”
According to Taylor, Cellumen’s strategy is to bifurcate its business, allowing the mother ship to continue to focus on drug discovery and drug development projects, while the offshoot can use its tissue-systems biology approach to develop diagnostics and theranostics for personalized medicine.
In fact, the name Cernostics is derived from the Latin cerno, meaning to separate.
Taylor explained that discovery toxicology is the ability to incorporate indicators of off-target liabilities sooner, and to marry them with efficacy models, so that efficacy and off-target effects are identified early on in the drug discovery process.
Discovery toxicology also involves developing more advanced panels to elucidate more complex systems responses to toxic challenges, so that “we can be predictive of them in both human and animal models.”
Cernostics will apply a similar technology to patient stratification. “What we do there is a little bit different. It is called tissue-systems biology,” said Taylor.
“We apply advanced classification methods and multiplexing in order to generate a score, so to speak, to determine the type of treatment that would be more appropriate for that particular patient.”
Cellumen has built an integrated platform with components to read tissue samples taken from patients. Then, “We apply advanced classification methods and multiplexing in order to generate a score, so to speak, to determine the type of treatment that would be more appropriate for that particular patient,” Taylor said.
“It’s a systems-based approach to stratifying patients, and to identifying which therapies might be most effective for them. What we are trying to do is be more predictive and able to elucidate and recognize that a tumor is really ‘a system within a system.’”
Cernostics is going to reside, at first, in the offices of Cellumen. However, Taylor said, “We see Cernostics evolving and getting its own funding, so it will be exploring independent funding and strategic collaborations.” He did not elaborate.
Cellumen will still own a portion of Cernostics, though Taylor did not disclose its stake in the firm.
According to Taylor, because Cernostics’ ”technology, IP, and collaborations already exist, we have already made a lot of strides and advances in the patient stratification market,” so now the spin-out is in the process of lining up investors.
The investment community will be able to invest either in patient sample profiling and personalized medicine through Cernostics, or discovery toxicology through Cellumen.
Cellumen expects the spin-out to grow rapidly. “Instruments alone in this diagnostics space represent a more than $2 billion market, and breast cancer is approximately a $300 million in vitro diagnostics market. And it’s growing rapidly,” said Taylor.
The Cernostics team currently includes Michel Nerderlof, who will join the company as its president and chief technology officer, and Rebecca Critchley-Thorne, who will serve as the company’s principal scientist. D. Lansing Taylor, chief executive officer of Cellumen, will serve as the chairman of Cernostics.
Taylor would not disclose its future hiring strategy. “Announcements will be forthcoming in the not-too-distant future about expanding the Cernostics team,” he said. “We are very well equipped to handle the business that we currently have.”
Cernostics is currently developing its new tissue-systems biology panels on a collaborative basis. Taylor said that although they are not yet commercially available, that is the intent.
“We will really need to study the outcome of the work that we are doing with the Mayo Clinic and some other collaborators that I cannot name,” he said.” In the course of these collaborations, there will be a lot of validation with pathologists to tweak the system and make sure that it is as accurate as possible.”