Med Device Monday: SEEKER System from Baebies

Baebies! No, not what Beyoncé is pregnant with.

When babies are born, they undergo routine screening for certain diseases that typically have better outcomes when detected early. Conditions tested for include, but are not limited to, heart conditions and congenital defects, early hearing detection and intervention, sickle cell (inherited red blood cell) disease, plus a range of conditions that can be detected in the blood. As the CDC states, "Newborn screening identifies conditions that can affect a child's long-term health or survival. Early detection, diagnosis, and intervention can prevent death or disability and enable children to reach their full potential. Each year, millions of babies in the U.S. are routinely screened, using a few drops of blood from the newborn's heel, for certain genetic, endocrine, and metabolic disorders, and are also tested for hearing loss and critical congenital heart defects (CCHDs) prior to discharge from a hospital or birthing center."

At the beginning of February, FDA approved marketing of a new device, Baebies' SEEKER, that will test babies for four rare metabolic disorders. Specifically, four Lysomal Storage Disorders (LSDs)–Mucopolysaccharidosis Type I (MPS I), PompeGaucher, and Fabry–that cause fats, proteins, sugars and other substances to not be eliminated from cells properly, due to low levels of the enzymes that usually help flush them out. If left untreated, these conditions can lead to life-threatening and life-ending complications including kidney and liver damage, neurological disability, stroke, heart attack, and more.

Per FDA, the Secretary of Health and Human Services "recently added Pompe and MPS I to the list of routine recommended newborn screening programs and it is anticipated that additional states will begin requiring use of screening tests to detect these disorders...Several states currently mandate LSD screening in all newborns, including Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Tennessee. However, until today [February 3, 2017] there were there were no FDA-authorized devices for screening of these disorders. Availability of the Seeker System provides laboratories with a screening tool that has been reviewed by the FDA for clinical and analytical validity. The Seeker System, consisting of the Seeker LSD Reagent Kit- IDUA|GAA|GBA|GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth. The Seeker Instrument is a device that automates the analysis of dried blood spots. Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder. Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies, genetic and other laboratory tests."

 Photo from baebies.com.

Photo from baebies.com.

The SEEKER integrates well with other tests currently performed as it is non-invasive and utilizes the heel prick that babies already get for other newborn testing. It tests dried blood spot specimens, meaning not much blood is required to carry out the test. The system is designed to be easy-to-use and results are provided on-site in fewer than four hours. Per the manufacturer, all that is required to set up a SEEKER testing work station is a desktop PC, back-up power supply, the required software, and four SEEKER instrument units that read the samples.

Per Baebies, "Newborn screening, widely recognized as one of the most successful public health programs in the U.S., ensures that all babies are screened for certain serious conditions at birth. The program started more than 50 years ago and has since expanded to include more than 30 metabolic and genetic diseases. The recent addition of Pompe disease and MPS I to the Recommended Uniform Screening Panel (RUSP) have brought more recognition to the benefit of early detection through newborn screening for LSDs."

Adding some quick and easy tests to the bevy of newborn testing–and in turn providing more positive long-term outcomes–is a win for all. 

 

Further reading:

Seeker System Classification Order