NEW YORK (GenomeWeb) – Diagnostics firm Carmenta Bioscience has begun a multi-center clinical trial for its protein-based preeclampsia diagnostic with the aim of launching the test sometime next year.
The company, which was co-founded by Stanford University researchers Atul Butte and Bruce Ling and has licensed preeclampsia protein markers from Stanford, plans to have initial results from the trial by the end of this year, CEO Matthew Cooper told ProteoMonitor.
The trial will look at a cohort of 300-plus subjects, including preeclampsia patients and controls with related conditions like chronic hypertension, gestational hypertension, and gestation diabetes. The company is enrolling subjects at nine centers around the US.
Cooper said that upon completion of this trial, Carmenta will likely begin enrolling a new set of subjects for a longitudinal trial of the company's second planned product, a predictive test to identify women at high risk of developing preeclampsia.
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.
Because preeclampsia symptoms overlap with a number of other conditions, however, it can be challenging to diagnose.
"When a woman comes in and presents with hypertension, doctors aren't sure if she has preeclampsia or if she just has chronic hypertension or if [for example] she has gestational diabetes and had a coffee on her way in so you're getting hypertension and proteinuria," Cooper said.
Each of these conditions, he noted, requires different treatments – making it important that physicians be able to tell them apart.
"If [a woman] has preeclampsia, [her doctors] are going to put her on a heavy monitoring program and probably prepare for preterm birth," Cooper said. "So they really need a test that can rule in or rule out preeclampsia upon early presentation of the symptoms. So that's what we have been focusing on."
This focus, Cooper noted, is a shift from the company's initial area of concentration – development of a point-of-care predictive test.
"When we first launched Carmenta back in 2012... I went out and interviewed dozens of OB-GYNs asking them if they would use such a product," he said. "And we got feedback very quickly that they didn't really want a point-of-care test and that, while they would love a test for asymptomatic women, the biggest and most immediate problem was actually confirming the diagnosis of preeclampsia in women who were symptomatic."
In its clinical trial, Carmenta is testing a panel of six protein markers. The ultimate composition of the test will be based on the results of the trial, Cooper said, noting that it could range from all six to a subset of as few as three of the proteins.
The original panel identified by Butte and Ling consisted of 24 proteins. In an initial trial of 32 cases and 32 controls, both the full 24-marker panel and a smaller seven-marker set identified women with preeclampsia with 100 percent accuracy.
The predictive test will feature the six proteins being used in the diagnostic test along with a few additional analytes, Cooper said. That test will be aimed at asymptomatic women with risk factors like obesity and hypertension, he said, with the goal of determining within the first trimester whether they will go on to develop preeclampsia.
"The question [with at-risk, asymptomatic women] is do we put them on bed rest? Do we have them take an aspirin regimen?" he said. "These are things that have been shown to decrease the incidence and severity of preeclampsia if you start them in the first trimester."
Carmenta plans to bring its diagnostic test to market as a laboratory-developed test, though, Cooper said, and the company has done much of the work under design controls that would enable a potential US Food and Drug Administration submission and transfer to an in vitro diagnostic platform down the road.
Whether the company does ultimately take the test down an IVD route will depend on things like future partnerships and its ex-US commercialization strategy, Cooper said.
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 in 2012 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, PGF.
Cooper likewise noted that Carmenta has received interest from a number of large IVD companies. He also said that the company has received considerable interest from noninvasive prenatal testing firms. In fact, he said, several such firms have expressed interest not only in partnering with but potentially acquiring Carmenta, though he did not name any potential suitors specifically.
"We have sort of a perfect companion product to their portfolio," he said, adding that "they all have OB-GYN sales forces."
Cooper cited Pronota as a competitor that might similarly be a target for acquisition by a NIPT firm, although he noted that given Pronota's assets in other areas including heart failure and sepsis, it would be "a messier asset for someone who just wants a preeclampsia diagnostic."
In fact, Pronota this week entered a new joint venture with Biocartis called MyCartis under which the two firms will continue development of Pronota's biomarker panels using Biocartis' Evaluation platform. The venture has completed a financing round of €15 million ($19.5 million) with investments from RMM, Valliance, and Biover II.
Assuming Carmenta remains an independent entity, it will probably seek to raise additional funding sometime next year, Cooper said. He added that it would most likely seek between $5 million and $10 million in additional funding, with the ultimate target depending on what, if any, partnerships it enters and how they affect its capital requirements.