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Stanford Spinout Carmenta Bioscience Prepping Validation Study of Preeclampsia Protein Dx

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Maternal and fetal biomarker firm Carmenta Bioscience said last week it has acquired an option for a global, exclusive license from Stanford University for preeclampsia biomarkers that it plans to develop into a diagnostic panel for the condition.

The company, which was co-founded by Stanford researchers Atul Butte and Bruce Ling, is currently working to put together a several-hundred-patient clinical trial that it hopes to launch sometime this year to test the markers, CEO Matthew Cooper told ProteoMonitor.

The company plans to test a panel of seven markers, with the aim of demonstrating their suitability as a confirmatory diagnostic for use in women symptomatic for preeclampsia. Assuming a successful trial, the company plans to commercialize the panel as a laboratory-developed test within the next few years, Cooper said.

Formerly the chief science officer at bioinformatics firm Syapse, Cooper came into contact with Butte and Ling through his role as an advisor to Stanford's Spark Translational Research Program, which helps commercialize research done by the school's scientists.

With funding from the March of Dimes, the two researchers had developed a panel of 24 protein biomarkers that looked promising as diagnostics for preeclampsia. Cooper, whose biomarker experience includes co-founding the biomarker development and validation group at Biogen Idec, advocated for the pair's research within Spark and, after it received funding from the program, Butte and Ling asked him to lead the commercialization effort.

"I took a month or two doing due diligence on it, interviewing fetal medicine specialists and Ob/Gyns to ascertain what the need was," Cooper said. "And after a couple of months I became convinced … that this was a great, venture-backable idea."

Characterized by high blood pressure and proteinuria, preeclampsia is a leading cause of preterm births and maternal-fetal deaths with between 5 and 8 percent of pregnant women developing the condition. According to Cooper, the annual market for a confirmatory diagnostic for use in symptomatic women would be around one million patients. The annual market for a predictive test for use in at-risk women would be around 1.7 million, he said.

In an initial trial of 32 cases and 32 controls, both the full 24-marker panel and the smaller seven-marker set identified women with preeclampsia with 100 percent accuracy, findings that Cooper noted were "great initial results," although he raised caution about the study's small sample size.

Now, he said, the company is putting together a larger clinical validation study involving hundreds of patients to test both the seven-marker panel as well as a larger set of 15 markers drawn from the overall 24.

Thus far, the seven-marker set has performed as well as the 15, but, Cooper said, "as you test larger and larger patient populations, inevitably one of them will fall out, one of them will become more important, etc."

"So if the seven-member panel works great, then, great, we're off to the races," he said. "But if for some reason it doesn't perform well then we have a bench to pull off of… we'll be able to tweak our panel if there's a need."

Carmenta is initially focusing on developing the panel as a confirmatory diagnostic, which, Cooper said, is what he has found in his discussions with physicians to be most in demand. In the future, the company may also pursue a test for gauging severity of the condition and monitoring patient progression as well as a predictive test for use in high-risk women.

It plans to bring the test to market in the US as an LDT and to license it outside the US to diagnostic firms for sale as an IVD. Cooper said the firm has chosen the LDT route for the US primarily to shorten the panel's time to market. He also noted the regulatory challenges of moving a multi-protein diagnostic through the US Food and Drug Administration, but said that regardless, the company would from the beginning develop the test under design controls that would enable it to more easily pursue an IVD strategy down the road.

An IVD approach could ultimately be advantageous given the interest large diagnostic companies have shown in preeclampsia. Katleen Verleysen, CEO of Belgian protein biomarker firm Pronota, which is also developing a preeclampsia test, told ProteoMonitor last year that such markers could prove a desirable complement to existing preeclampsia offerings from firms including Roche, Abbott, and PerkinElmer, each of which already has tests for the preeclampsia biomarker placenta growth factor, PlGF (PM 7/13/2012).

"Every big [in vitro diagnostic] company has an interest in preeclampsia because they all have licenses to PlGF," Verleysen said. "So if we have a test that can identify early on in pregnancy who will be at high risk of developing preeclampsia, that will be very useful to those companies."

She added that Pronota, which is currently undertaking a prospective, 2,000-patient clinical study of its panel to support a US Food and Drug Administration 510(k) submission and an application for a European Union CE mark, is in discussions with Roche, Abbott, and PerkinElmer about potential deals for the test.

According to Cooper, Carmenta is likewise exploring deals for its panel and is "in late-stage discussions with a few IVD companies" to license rights to the test for outside the US.

In addition to Pronota, Carmenta could face competition in the preeclampsia protein marker space from Sera Prognostics, which has identified several peptides that it believes are predictive of the condition (PM 1/7/2011). On the genetic side, GATC Biotech and its subsidiary LifeCodexx are developing next-generation sequencing tests for preeclampsia.

Cooper said Carmenta is currently raising money to support clinical validation of the panel, noting that it has raised a small amount of initial capital from private investors and is now "in negotiations with some biopharmas that have an interest in women's health, some venture capitalists, and some diagnostic companies."

A deal with a biopharma could be particularly advantageous, he said, given that in addition to funding, they would like be able to bring clinical samples to the table.

"If I sign a deal with biopharma, and they are like, 'Here are 400 samples, get started,' then I can get to market really fast," he said.

Cooper is currently Carmenta's only full-time employee. The company employs part time five other executives with experience in the diagnostic field, he said, adding that he plans to use the funds he's pursuing to bring them on full time.

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