Baebies SEEKER is an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER installs easily into your newborn screening lab, requiring no renovations or additional equipment. Simply plug it in!
Introduction video for SEEKER, an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER is the ideal solution to empower your newborn screening lab and integrates easily into your workflow.
Missouri will be the first state in the US to screen for mucopolysaccharidosis II (MPS II), otherwise known as Hunter syndrome and spinal muscular atrophy (SMA), two life threatening genetic diseases. The state is already screening for several LSDs using the SEEKER platform. Florida recently passed legislation that requires the Advisory Council to consider every condition added to the RUSP within 1 year, and if recommended, the NBS lab would be required to screen for that condition within 18 months.
Baebies is pleased to announce that SEEKER, a high throughput newborn screening laboratory solution, now has CE Mark and available in Europe and other countries that recognize CE Mark. SEEKER quantitatively measures the activity of lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry disease.
Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced the first assays on the FINDER launch panel, currently under development. The panel includes tests for total serum bilirubin, albumin, direct bilirubin, and glucose-6-phosphate dehydrogenase (G6PD) on a single cartridge, making it the first comprehensive, rapid and near-patient testing solution for hyperbilirubinemia. A robust pipeline of future panels for other disorders using the same cartridge on FINDER is also in development.
Dr. Millington refutes further misinformation regarding the application of ‘equivalent cutoffs’ to prospective NBS data, misleading comparisons of MS/MS and fluorometry GAA testing methods and the effect of preanalytical variability on LSD NBS results.
Newborn screening of lysosomal storage disorders (LSDs) can be performed using different methods, workflows, screening algorithms, assay protocols, reagents/kits and instruments, all of which impact the output of the test. “Equivalent cutoff” has been proposed as a method to normalize screening results across LSD screening platforms. In this white paper, we review the validity of the recently proposed “equivalent cutoff” and the critical shortcomings in the effectiveness of this idea, including how it ignores the cardinal rule of newborn screening: to minimize the chance of a false negative result.
A major goal of any newborn screening laboratory is to adopt screening methods that best identify those at-risk for a particular disorder. Although the term analytical range has recently been presented as a metric for method performance comparison for newborn screening of lysosomal storage disorders, it is a poor comparator of assay platforms. Download our free white paper to learn why Z-factor is the superior metric over analytical range when comparing newborn screening assay performance.
Dr. David Millington, pioneer of expanded newborn screening, and Dr. Deeksha Bali, expert in LSD diagnostic methods, address persistent misinformation regarding current methods for newborn screening of LSDs.
Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has completed a $5 million first close on its Series B financing. The company plans to raise an additional $5 million in the coming months. Baebies received clearance from the U.S. Food and Drug Administration (FDA) for its SEEKER newborn screening system earlier this month.