A Critical Neonatal Diagnostic Problem

NeoMetrix Dx was founded to satisfy an unmet clinical need affecting over 70% of the 3.8 million babies born in the US annually and is applicable to tens of millions of newborns worldwide. We are uniquely positioned to rapidly dominate this billion-dollar market, protecting the health of tens of millions of babies born each year while significantly reducing the cost of neonatal healthcare. Jaundice is a yellowing of the skin due to the transient buildup of bilirubin in the blood. It affects 70% of newborns in the US and unchecked may lead to toxic levels of bilirubin in the blood (hyperbilirubinemia). Severe hyperbilirubinemia may cause a spectrum of brain damage known as Bilirubin-Induced Neurological Dysfunction (BIND) including hearing loss, visual impairments and athetoid cerebral palsy and a wide range of other neurodevelopmental impairments. Total serum bilirubin (BT) is the only clinical diagnostic test currently available to help determine which of these newborns require treatment. Unfortunately, BT alone is widely known to lack both sensitivity and specificity and is a poor predictor of which babies need treatment:

  • The false-negative rate of the existing BT test is reported to be in the 8-10% range. This under- diagnosis leads to withheld or delayed treatment that can result in permanent brain damage.
  • The false-positive rate is reported to be 50-80%. This over-diagnosis leads to expensive hospitalization and readmission of otherwise healthy newborns, which causes significant maternal anxiety, interference with breastfeeding, and disruption to newborn-mother bonding.

A PROBLEM IN NEED OF A SOLUTION

Clinicians have known for some time that it is the unbound or free bilirubin (Bf), making up less than 1% of total serum bilirubin that can cause brain damage. And that it is critically important to understand each newborn’s unique capacity to bind bilirubin in order to make treatment decisions. Unfortunately, there is currently no automated diagnostic test available to clinicians that measures Bf or bilirubin binding characteristics. As a result, clinicians and medical regulating bodies have made measurement of Bf and associated binding characteristics a priority.