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Carmenta Bioscience to Take Preeclampsia Test, Streamlined Dx Development Approach to Progenity

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NEW YORK (GenomeWeb) – Progenity said today that it has acquired proteomic diagnostic company Carmenta Bioscience.

A spin-out of Stanford University, Carmenta is focused on developing a protein-based test for preeclampsia, a hypertensive disorder of pregnancy. Preeclampsia is a leading cause of preterm births and maternal fetal deaths, with between 5 and 8 percent of pregnant women developing the condition.

Under the terms of the acquisition, Carmenta CEO Matthew Cooper will join Progenity as chief scientific officer. The acquisition price and other terms of the agreement were not disclosed.

Carmenta is currently involved in a multi-center clinical trial for a six-protein preeclampsia test, looking at a cohort of several hundred patients and controls with related conditions.

The company had planned to launch its preeclampsia test sometime this year. However, those launch plans have been put on hold as Progenity looks at how to proceed with the newly acquired assets, Cooper told GenomeWeb this week.

The Progenity deal, he said, stemmed from discussions between Carmenta and several large diagnostic firms about partnership opportunities that would allow Carmenta to leverage these firms' commercial operations for the launch and marketing of its test.

"These discussions about partnerships turned into discussions about acquisitions, and here we are," Cooper said.

Carmenta began pursuing partnerships shortly after its founding. In a 2013 interview, Cooper told GenomeWeb that the company was "in late-stage discussions with a few IVD companies" to license rights to the test for outside the US."

From Progenity's perspective, Carmenta's preeclampsia assets fit into the company's preexisting focus on maternal and fetal health. The company offers a variety of prenatal genetic tests including Illumina's Verifi noninvasive prenatal testing panel.

Cooper said that in his new role as Progenity CSO he will look to expand the company's test portfolio and move into new technologies such as proteomics.

Founded by Stanford researchers Atul Butte and Bruce Ling, Camenta launched in mid-2013 with $2 million in seed funding. The company's preeclampsia test is based on biomarkers identified by Butte and Ling and licensed from the university.

Speaking to GenomeWeb this week, Butte highlighted the acquisition as a success story for a streamlined model of biomarker discovery and development, for which he is an advocate. Carmenta, he noted, was able to go from initial biomarker discovery work to construction of a diagnostic panel for preeclampsia, to acquisition by Progenity in around two years — with roughly $2 million in funding and only one full-time employee, Cooper.

Key to the company's strategy was constructing its biomarker panel via meta-analysis of existing experimental data, as opposed to performing large-scale discovery experiments on its own, Butte said.

"We put [existing] gene expression microarray datasets together to figure out consistent gene expression markers that might be upregulated [in preeclampsia], and from that we [moved] into plasma protein measurements," he said.

"There was a lot of work to determine what those markers were and how this was going to work," Butte said. Nonetheless, the approach was significantly less resource-intensive than starting biomarker discovery from scratch.

"It really does showcase what I've been trying to say for a long time," he said. "There is value in these public datasets."

Butte and his colleagues presented their approach in a paper published in BMC Medicine in 2013. 

In the study, they combined data from seven previously published transcriptomic placental studies along with their own 2D gel analysis comparing serum proteins in preeclampsia and control subjects. From this analysis they identified both a 24-protein panel and a smaller seven-marker panel, both of which they tested using ELISAs in a set of 32 cases and 32 controls, finding that both panels identified the women with preeclampsia with 100 percent accuracy.

Ultimately, Carmenta took a six-protein panel into the clinical trials it launched last year. That trial, which is still ongoing, plans to look at 300-plus subjects, including preeclampsia patients and controls with related conditions like chronic hypertension, gestational hypertension, and gestational diabetes.

Butte, who said that he will likely remain involved with the company in some capacity, said that Carmenta's effort also demonstrated the potential effectiveness of purchasing study samples from commercial entities, at least in the early stages of test development.

For the BMC Medicine study, he and his colleagues purchased samples from specimen provider ProMedDx.

Such companies allow researchers to "get samples off the internet, basically," Butte said. "It's amazing how far you can get by just at least getting started with [such samples]." 

"Once you show that something works with [those samples], then of course you take it further," he added. "It's not the end all, but it's at least enough to get started in the early stages of discovery for a diagnostic."

One of Carmenta's primary competitors in developing a proteomic test for preeclampsia was Belgian diagnostics firm Pronota, which last year was incorporated into a new venture with MyCartis called BioCartis. Before joining to form BioCartis, Pronota had been "extremely close" to merging with a California-based molecular diagnostics firm, former Pronota CEO Katleen Verleysen told GenomeWeb last year. She declined to name the company.

BioCartis's first test will be a cardiac panel consisting of RNA and protein markers, with a preeclampsia panel based on Pronota's markers second in line for commercialization.

Another firm that has shown an interest in preeclampsia is Sera Prognostics, which has identified several peptides that it believes are predictive of the condition. Additionally, a number of large diagnostic companies, including Roche, Abbott, and PerkinElmer, have tests for the preeclampsia biomarker placenta growth factor, PlGF.

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