Event – Baebies is an FDA attention Seeker

Analysis

Attempts to detect disease using smaller than usual blood samples do not always go smoothly. The newborn screening specialist Baebies will hope that an FDA advisory panel convening on August 10 endorses its Seeker platform, designed to measure enzymatic activity from dried blood spot specimens.

The company has applied for de novo clearance for Seeker, which uses digital microfluidic technology – licensed from the genome sequencing giant Illumina – to precisely manipulate droplets of the sample, in this case blood. This allows for smaller samples and instruments, the company says, which could make screening more convenient.

The de novo application covers four disorders: mucopolysaccharidosis type I disease, Pompe disease, Gaucher disease and Fabry disease. If the FDA approves the device, it seems likely that Baebies will apply for clearance in additional disorders.

Newborns in the US are currently routinely screened using blood spot testing for an average of 43 conditions, the company says. A few drops of blood from a baby’s heel are collected on a blood spot card and sent to a central lab for analysis, and results are usually returned within a few days. Companies involved in processing these samples include the large lab service providers like PerkinElmer and Quest Diagnostics.

In other countries screening is patchier. Baebies notes that more than 100 million babies born worldwide each year are not tested for “even the most basic treatable congenital disorders”.

Finders and Seekers

While Seeker could be an incremental improvement over other lab-based machines, Baebies’ second platform, Finder, promises a bigger leap forward. This is only eight inches wide, and is designed for various point-of-care settings including hospital nurseries or labs, neonatal intensive care units and birthing centres.

The company claims it is the world’s first near-birth newborn-testing platform, promising quicker and more convenient detection of disease. Conventional lab testing can return results too late, Baebies says, and the fact that Finder uses “tiny droplets of blood” means that it is less painful for the baby.

Baebies is initially developing a test for a panel of markers for hyperbilirubinemia, which it says cannot be performed using the traditional central lab method. The group hopes to make Finder commercially available in 2017. 

Illumina links

Of course, the company will have to prove that its tech works – this is where Theranos, another company promising tests using a single drop of blood, fell down.

Baebies' core technology was originally developed at Advanced Liquid Logic, which was acquired by Illumina for $96m in 2013. At the time, Illumina said it would use the digital microfluidics tech to streamline its next-generation sequencing workflow. It appears that protein analysis is surplus to requirements, so Illumina has licensed that application back to Baebies. The agreement between Illumina and Baebies does not cover sequencing.

Baebies has other links to the bigger company, with Illumina Ventures' founding partner Nicholas Naclerio sitting on its board, though the group does not seem to count Illumina among its investors. Baebies closed a $13m funding round in July 2015 with backers including Rex Health Ventures, Cunning Capital, Triad and the Duke Angel Network.

The signs for Baebies seem promising, but first it must to focus on the task in hand: getting approval for the Seeker device.

To contact the writer of this story email Madeleine Armstrong in London at madeleinea@epvantage.com or follow @medtech_ma on Twitter

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