A new high-tech blood test may be able to help doctors identify pregnant women at risk for having their babies too soon.
Pre-term birth is an expensive and traumatic problem. According to the March of Dimes, almost 500,000 babies are born before 37 weeks.
An Institute of Medicine report from 2006 found that medical bills and other costs related to prematurity were $26.2 billion in 2005. Premature birth takes a high toll on families too.
NX PharmaGen’s test harvests exosomes from a blood sample and looks for a specific biomarker fingerprint that indicates a high risk for pre-term birth, even in women with no known risk factors.
“If you harvest exosomes and open them up and look at their content, the protein content of a term pregnancy looks very different from a preterm pregnancy,” Brian Brohman said.
A former J&J executive, Brohman founded the company with Dr. Alan Ezrin in 2010.
Exosomes are nano-sized structures that are released from many cell types. They are found in blood, urine, and amniotic fluid. Exosomes are believed to transport a range of molecules, including mRNAs, miRNAs, and proteins, depending on what kind of cell they came from. Because they are enclosed in a membrane, the contents are protected and perfect for diagnostic use.
“The early data that we are producing show the cargo is quite important and can tell you something very distinct,” Brohman said. “The attraction to folks in the field is noninvasive way to get a real time view of the changes that are happening.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The company has conducted early studies with maternal serum samples. The two cohorts were balanced for age and subjects were asymptomatic with no known risk factors, such as hypertension, twins, or gestational diabetes. The average age was 28. In the study, a pre-term birth was before 34 weeks and after 37 weeks was full-term.
As early as 15 weeks, the test could detect a risk for pre-term birth. NX PharmaGen’s initial human studies also suggest the test could be used for early detection, sub-typing/staging, drug receptor presence/absence, and recurrence monitoring for cancer, including lung cancer, ovarian cancer, and brain cancer.
The initial benefit of the NeXosomeTM Preterm Birth Assay would allow doctors to move a patient from normal OBGYN care to a fetal medicine specialist.
“This is a tool to tell doctors where they should be spending extra time,” Brohman said. “If you can extend the pregnancy on knowledge of a risk, you can save lots of money,”
The test does not indicate anything about the fetus. It only reflects the environment that the fetus is developing in.
The goal is to make the exosome test part of the standard quad screening in the second trimester. The blood drawn for this test can be used for the pre-term birth test as well.
The smart slotting of the test into an established part of prenatal care reflects the experience of Jackie Willmot. She is the vice president of prenatal diagnostics and a perinatal clinical nurse specialist with 30 years of industry experience that includes 13 yrs of high risk OB/NICU & 15+ yrs of business/payer/reimbursement experience with Humana. While at Humana, Willmot led the design, launch and operations of HumanaBeginnings Prenatal At-Risk Maternity Program.
“Jackie is helping us understand the importance of this test for the payers, understand economics and problems they’d like to solve and putting it together in ROI models that speak their language,” he said.
The other two members of the executive team also have many years of experience in starting and exiting healthcare companies. Brohman was a licensing/business development professional at J&J’s Cordis medical devices division, and has been the founding CFO/CBO of biotech startups Aptamera (sold to Antisoma), and Bradmer Pharmaceuticals (IPO’d on TSX). Ezrin was a co-founder of Cardiome Pharma and ConjuChem, both of which matured from start-up stage to multi-hundred million dollar market cap firms under his leadership.
Next steps for NX PharmaGen are assay optimization and validation. Brohman said that it is too early to know which regulatory path the company will take: CLIA LDT and an FDA approval.
The company is seeking patents on the biomarker pattern that indicates a high risk of premature birth and the method of harvesting exosomes from a blood sample.
[Image of baby in incubator from BigStock photo]
