TACOMA, Wash. – A team of researchers at a U.S. Army infertility clinic has developed a fast and reliable genetic test for detecting ectopic pregnancies.
Developed at the Madigan Army Medical Center, the new test analyzes 12 genes collected from an endometrial biopsy. The results indicate whether the embryo is located in a nonviable location, intrauterine or ectopic.
Ectopic pregnancy accounts for one to two percent of all pregnancies in the United States and remains the leading cause of maternal death in the first trimester.
Diagnosing an ectopic pregnancy is currently performed using transvaginal ultrasound, most are located within the fallopian tube, but sometimes the location cannot be visualized.
After the ultrasound, the next test currently used, which assesses pregnancy-related hormones, gonadotropin, and progesterone, is limited by high false-positive and false-negative rates.
“Definitive diagnosis can be time-consuming and cumbersome, often requiring multiple office visits, serial blood draws, ultrasound examinations, and surgical procedures over a period of time which may span several weeks,” according to the Army’s December 26 patent application publication.
In contrast, the Army’s new test requires one patient visit with a medical laboratory producing same-day results.
The technology was validated using tissue samples from 36 volunteers.
Dr. Jessica Lentscher, a U.S. Army captain who helped invent the test, said that early identification of the location of a pregnancy outside of the uterus enables early treatment and the avoidance of a rupture.
“I’m really appreciative of all of the patients who have consented to be a part of this study, especially given that this situation is most of the time really disappointing and difficult, but these patients are going above and beyond in hoping to further our knowledge in the care of future generations,” Lentscher said.
Technology Licensing Opportunity
Following the research effort, the Army filed for a U.S. patent – the application was made public on Dec. 26, 2019, and also lists Nicole Ortogero, Richard Burney, Gregory Chow, Zachary Colburn, as co-inventors.
Qualified healthcare companies can now pursue the development of the test into a widely available tool through a patent license agreement.
Dr. Quinton King, senior technology manager at TechLink, confirmed the availability of licenses last week.
“This is a fantastic opportunity for a company supporting women’s health to develop and deliver a critically needed medical technology,” King said.
Contact Quinton King at firstname.lastname@example.org or reach him by telephone at 406-994-7795.