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NX Prenatal Aims to Bring Preterm Birth Test to Market Sooner With NxGen MDx as Partner

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NEW YORK (GenomeWeb) – With its recently announced partnership with genetic testing firm NxGen MDx, NX Prenatal aims to establish a foothold in the maternal-fetal medicine market as it moves towards commercialization of its test for preterm birth.

"NxGen is very knowledgeable in this space, and they are in close touch with our intended customers, so our thinking is that working with a company like NxGen can accelerate our path to the market," NX Prenatal CEO Brian Brohman told GenomeWeb this week.

Louisville, Kentucky-based NX Prenatal is developing a proteomic test for assessing women's risk of delivering prematurely. The company uses multiple-reaction monitoring mass spec to measure exosome-bound proteins linked to preterm birth. In a 75-patient study published in March in the American Journal of Obstetrics and Gynecology, the company presented a number of three-protein panels that, when measured between 10 and 12 weeks of gestation, were able to identify women who would go on to have a preterm delivery with a sensitivity and specificity of above 80 percent each.

NX Prenatal is now performing a similar study in a larger cohort with the goal of further refining its protein signature, Brohman said. He declined to give a target date for commercialization of the test, but said that the goal of the NxGen MDx partnership was to bring the test to market "as soon as possible."

Founded in 2012, NxGen MDx focuses primarily on genetic carrier screening, for which it uses next-generation sequencing. Using mass spec-based proteomics, NX Prenatal's test is a somewhat different product, but both are aimed at the same sets of physicians and patients.

For proteomics test makers, commercial concerns like driving physician adoption and winning payor coverage has proven at least as challenging as the scientific side of test development. While a number of companies have managed to bring proteomic tests to market, few have scored big commercial hits, and many have struggled to establish effective commercial infrastructures and strategies.

In the past, firms like Vermillion outsourced many of these efforts via licensing deals with large clinical reference labs. In Vermillion's case, though, the company came to believe its test was not receiving the targeted attention needed to drive adoption of a new specialty test from its partner Quest Diagnostics, and it terminated the licensing deal after xx years.

More recently, some companies, similar to NX Prenatal, have taken a more targeted approach, looking to partner with firms focused on similar healthcare questions and needs. To aid commercialization of its Promark prostate cancer test, Metamark Genetics actually purchased a urology-focused anatomic pathology business from HealthTronics Laboratory Solutions in 2013. That deal gave Metamark the full commercial infrastructure required to support the launch of its test, including reimbursement specialists, a billing and collections department, laboratory facilities, a national sales force, and a customer base of roughly 500 US urology practices comprising some 2,500 urologists.

NX Prenatal hopes through the NxGen MDx deal to gain access to assets needed for commercialization of its test in a similar way.

"Historically [NxGen MDx] is primarily involved in genetic carrier screening types of tests, but they are specifically calling on the OB-GYN and maternal fetal medicine community, and are quite in touch with things they would need in terms of new diagnostic products," Brohman said. "They have full commercial capabilities from all of the lab operations through to the commercial infrastructure, which includes everything from sales folks all the way through to relationships with payors and all the billing capabilities and everything you need to have a successful launch."

NxGen MDx could also expand NX Prenatal's access to clinical study cohorts, Brohman said. "Some of the folks they have worked with historically are not the same as the folks we have worked with, so there are some nice synergies there."

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