Features | Partner Sites | Information | LinkXpress
Sign In
FOCUS DIAGNOSTICS, INC.
AB Sciex
RANDOX LABORATORIES

High-Tech Blood Test Predicts Premature Birth Risk

By Labmedica International staff writers
Posted on 27 Feb 2013
A blood test that predicts preterm birth harvests exosomes from a blood sample and looks for a specific biomarker fingerprint that indicates a high risk for preterm birth, even in women with no known risk factors.

NX PharmaGen (Louisville, KT, USA) has conducted early studies with maternal serum samples using its NeXosome Preterm Birth Assay. 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 preterm birth was before 34 weeks and after 37 weeks was full-term.

As early as 15 weeks, the test could detect a risk for preterm 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.

“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,” commented Brian Brohman, co-founder and chief business officer of NX Pharmagen.

The initial benefit of the NeXosome Preterm Birth Assay will 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,” Brian Brohman said. “If you can extend the pregnancy on knowledge of a risk, you can save lots of money.”

Next steps for NX PharmaGen are assay optimization and validation. Brian Brohman said that it is too early to know which regulatory path the company will take: Clinical Laboratory Improvement Amendments a laboratory-developed test (CLIA LDT) and an US Food and Drug Administration (FDA; Silver Spring, MD, USA) 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.

Related Links:

NX PharmaGen




PURITAN MEDICAL
DiagCor Bioscience
77 ELEKTRONIKA
comments powered by Disqus
Life Technologies

Channels

Clinical Chemistry

view channel
Image:  The Agilent 6890 GC with 5973 Mass Spectrometer and Tekmar Velocity XPT Purge & Trap (Photo courtesy of Gen Tech).

Low Levels of Prohormone Predicts Coronary Heart Disease

The adrenal sex hormone dehydroepiandrosterone (DHEA), which is present in serum mainly as the sulfate DHEA-S, is the most abundant steroid hormone in human blood and its levels decline dramatically with age.... Read more

Microbiology

view channel
Image: The causative parasite of Chagas disease Trypanosoma cruzi in a blood film (Photo courtesy of the CDC - US Centers for Disease Control and Prevention).

Undiagnosed Chagas Disease Emerging as Public Health Threat

Chagas disease or American trypanosomiasis is typically spread to people through the feces of blood-sucking triatomine bugs sometimes called kissing bugs because they feed on people's faces during the night.... Read more

Pathology

view channel
Image: The Isolation by Size of Epithelial Tumor cells (ISET) technology (Photo courtesy of Rarecells Diagnostics).

Circulating Tumor Cells Allow Early Diagnosis of Lung Cancer

Chronic obstructive pulmonary disease (COPD) is a risk factor for lung cancer and migration of circulating tumor cells (CTCs) into the blood stream is an early event that occurs during carcinogenesis.... Read more

Industry News

view channel

Oncology Companion Diagnostics Sector Grows to Over USD 1 Billion

The market for diagnostic test and pharmaceutical drug pairs for cancer treatment has grown significantly, according to the report “Companion Diagnostic Markets” from healthcare market research firm Kalorama Information (New York City, NY, USA). The global companion diagnostics (CDx) market is valued at about USD 1.... Read more
 
Copyright © 2000-2014 Globetech Media. All rights reserved.