Publication Calls for New Biomarker Testing to Support Patient Identification to Facilitate Interventions as Early as the First Trimester

BELLAIRE, TX, UNITED STATES, August 6, 2024 /EINPresswire.com/ -- The Preterm Birth International Collaborative Global (PREBIC) recently released a major new publication supporting the need for biomarker-based testing for pre-term birth in Frontiers in Medicine. The publication, “Assessment of Current Biomarkers and Interventions to Identify and Treat Women at Risk of Preterm Birth,” highlights the high need for, “Reliable biomarkers that can be used in low-risk and nulliparous populations that would allow early targeted intervention.” NX Prenatal applauds the publication and currently has the only first-trimester biomarker-based test in development to detect spontaneous pre-term birth (sPTB) in nulliparous women. This is critical as the test is performed in conjunction with the typical first prenatal visit. A recent validation study published in the American Journal of Obstetrics and Gynecology, which evaluated 400 patients consisting of pre-term birth samples and healthy controls, demonstrated the ability of the company’s Time-to-Prepare test to predict sPTB. Women in the study who were determined to be at high-risk had a 20x higher rate of sPTB when compared to low-risk patients.

“There is a comprehensive need for high quality biomarker-based tests used in conjunction with clinical risk factors to help predict pre-term birth in women,” said Michael Gravett M.D. Professor of Obstetrics & Gynecology, Maternal-Fetal Medicine at the University of Washington, and the senior author on the PREBIC paper. “Numerous studies have demonstrated that early clinical intervention through a combination of approaches can significantly reduce the rate of pre-term birth and neonatal mortality.”

Several publications have shown the ability of early intervention to reduce pre-term birth rates in high-risk women. A 2011 study published in Ultrasound Obstetrics Gynecology consisting of 465 women showed a 45% reduction in rates of pre-term birth before 33 weeks (p=0.02) through the use of vaginal progesterone in high-risk women. Additionally, a 2020 study of 11,976 women published in the Lancet showed that low-dose aspirin administered throughout the pregnancy reduced the rate of pre-term birth by 11% (p=0.012). Furthermore, intensive care management through a maternal fetal medicine specialist has also been shown to reduce rates of pre-term birth. A 2021 study of 3,565 patients published in the American Journal of Obstetrics and Gynecology showed that intensive care management reduced the rates of pre-term birth by 33% (p<0.001). Finally, a combination of these strategies has shown to have potentially even a larger impact on rates of pre-term birth. A 2009 study conducted by Parkland Memorial Hospital including 260,197 women which was published in Obstetrics & Gynecology showed that the implementation of an intensive intervention strategy was able to reduce their rate of pre-term birth by 53%.

“Studies have shown that early intervention and referral to a trained specialist can improve outcomes and limit complications around pregnancy,” said Thomas F. McElrath M.D. PhD, Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. “However, clinical risk factors alone only identify approximately 10% of patients who will go on to have a pregnancy complication. Therefore, accurate diagnostics are critical to identifying and treating patients.”

NX Prenatal is currently completing the largest clinical validation of a pre-term birth study ever conducted in approximately 600 patients which will support the future commercialization of the test.

“We fully agree with PREBIC on the need for comprehensive biomarker testing to prevent pre-term birth in the United States and globally,” said Paul Kortschak, CEO of NX Prenatal. “With 10% of births pre-term in the United States and even higher rates in developing countries, this is a global challenge that costs the U.S. healthcare system approximately $26 billion annually in direct medical costs. Early diagnosis and intervention is the only path to ensuring the health of moms and babies and reducing the burden on our healthcare system.”

About NX Prenatal:

NX Prenatal Inc. is a private, US-based molecular diagnostics company recognized for its innovative work developing new exosome-based liquid biopsy tests for the large maternal-fetal medicine market. The company's proprietary multiplexing and AI/ML-driven platform is being utilized to develop enabling, early warning systems for adverse pregnancy outcomes including preterm birth, preeclampsia and placenta accreta. For more information, please visit the company's website at www.nxprenatal.com.

Scott Gleason
NX Prenatal Inc
+1 8016579803
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