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.
Not only can the NIR method distinguish unique biomarker profiles for different neurological diseases, but these profiles are also distinctly different from those of healthy, age-matched controls, notes Dr. Posillico. There are no proven biomarkers for Parkinson’s, and two clinically useful biomarkers for Alzheimer’s need spinal fluid samples. “Our test only requires a finger prick to get seven microliters of plasma,” he reports.
The information obtained from NIR could be used for the early detection of neurodegenerative disorders or to monitor the efficacy of drugs on the market or in development, explains Dr. Posillico. Patients with Alzheimer’s and Parkinson’s take powerful drugs for years, yet there are few biological metrics for measuring how long-term treatment affects patients. “The potential application of our technology platform to drug discovery and development is very high,” he says.
Another application of the NIR technology is for lactic acid (lactate) monitoring, which is replacing complicated measurements of blood gases and enzymes in critical-care units and emergency and operating rooms. “Lactate is viewed as a first-line indicator of a patient’s metabolic state and general health,” explains Dr. Posillico, but a blood sample must be drawn and sent to a laboratory for analysis. Molecular Biometrics is testing a noninvasive finger cuff monitor, similar to ones used in pulse oximetry.
Products for monitoring neurodegenerative diseases, preterm labor, and lactate status are in the pipeline, but it will take more money to develop and market these products. “We saw a more straightforward opportunity to enter the IVF market first with our platform,” Dr. Posillico says, “then we’ll build other disease applications.”