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Columns : Apr 1, 2008 ( )
Increasing the Odds of In Vitro Fertilization
Molecular Biometrics Uses NIR Spectroscopy to Detect Embryo Viability by Creating Metabolic Profiles!--h2>
While viewing an exhibit of Monet’s impressionistic paintings, Jim Posillico, Ph.D., president and CEO at Molecular Biometrics in Chester, NJ, noted the similarity of the art with his company’s metabolomics platform.
Like the discrete brush strokes, textures, and colors that interact to form an impressionistic image, “metabolomics looks at the bigger picture from its constituent parts,” Dr. Posillico explains. The individual pieces of information in metabolomics are molecular biomarkers in biological samples, which give an accurate diagnostic profile of a biological condition or state of cellular activity.
The technology platform at Molecular Biometrics combines metabolomics with near infrared (NIR) spectroscopy. The company’s lead product, ViaTest-E™, tests the viability of embryos at in vitro fertilization (IVF) clinics to increase the chance for a successful pregnancy. The test uses NIR spectroscopy to detect biomarkers of oxidative metabolism that strongly correlate with embryo viability.
The groundwork for the company’s biospectroscopy-based metabolomics platform was done in the laboratory of chemist David Burns, Ph.D., at McGill University in Montreal, Quebec. Dr. Burns and Dr. Posillico, an endocrinologist, cofounded Molecular Biometrics in 2005 and licensed five broad patents from McGill University, which cover applications of metabolomics and different forms of spectroscopy to different medical conditions including fetal development and neurodegenerative diseases like Alzheimer’s and Parkinson’s.
The company invented a prototype instrument, about the size of a toaster, for use at IVF clinics. After confirming that NIR is as sensitive as NMR or Raman spectroscopy for identifying and quantifying biomarkers, the company selected NIR because it is affordable and does not require much technical know-how to operate, reports Dr. Posillico.
The average infertile couple undergoes three cycles of IVF treatment while trying to become pregnant. Embryologists currently have no reliable biological ways to distinguish viable and nonviable embryos, and only about 15% of embryos transferred in IVF result in pregnancy. “We hope to reduce the number of cycles needed to achieve pregnancy by increasing the efficiency of picking viable embryos that have the highest chance of resulting in pregnancy,” explains Dr. Posillico.
The product will first be launched in Japan, Australia, and Europe, followed by the U.S., which has 425 IVF programs. The company recently completed a large clinical trial of 1,800 women at centers in Europe, Japan, Australia, and the U.S. that validated the specificity, selectivity, and utility of the ViaTest-E in IVF, according to the company. Dr. Posillico is working with the FDA to move forward with a pivotal trial to clear the way to marketing the NIR instrument.
By monitoring different biomarkers and modifying algorithms, the NIR instrument also detects biomarkers of oxidative metabolism in blood plasma samples from patients with Parkinson’s and Alzheimer’s disease. “The beauty of our technology is that you don’t have to invent a different instrument to measure a different disease state,” Dr. Posillico adds.
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