NEW YORK – Despite its name, Durham, North Carolina-based diagnostic firm Baebies isn't only creating tests for children.
While it is focused on neonatal, newborn, and pediatric screening, the company's CEO Richard West noted that its platforms are perfectly capable of doing tests on adults as well, such as its SARS-CoV-2 test, pending Emergency Use Authorization from the US Food and Drug Administration.
The firm recently received up to $11.6 million from global nonprofit CARB-X in non-dilutive funding to develop its near-patient Finder platform for sepsis for neonates and children. The award includes $3.9 million in initial funding with up to $7.7 million of milestone-based funding. The firm has also raised about $40 million in equity capital since its beginning and has received more than $35 million in federal funding mostly from the National Institutes of Health, West said.
On Wednesday, the company announced that it has received $2.7 million in a Phase IIB Small Business Innovation Research grant from NIH's National Heart, Lung, and Blood Institute to support validation, clinical evaluation, and submission to the FDA for its heparin monitoring test, developed in partnership with Boston Children's Hospital. The assay monitors blood coagulation condition for patients who have undergone cardiac surgery.
The platform is Baebies' second, following its Seeker instrument, which has been its primary source of product revenue to date and is used to test 1 out of every 7 babies born in the US, West said. However, the Finder platform, along with its hematology and enzyme activity test for glucose-6-phosphate-dehydrogenase deficiency, a genetic defect leading to anemia in babies that is often a cause of severe jaundice, is pending 510(k) clearance with the FDA with expectations it will have a significant impact on the pediatric diagnostic space.
The platform received the American Association for Clinical Chemistry's Disruptive Technology Award at the organization's Annual Scientific Meeting last year and was named a finalist for the 2021 Medical Design Excellence Awards.
In a study conducted at Stanford University School of Medicine's department of pediatrics and published in Seminars in Perinatology in December, Finder was able to measure G6PD enzyme activity reproducibly and found to highly correlate with standard biochemical tests "with minimal bias and imprecision." The researchers concluded that the instrument "could be used as an accurate [point-of-care] screening tool for early newborn G6PD screening," although they noted the clinical performance and diagnostic utility needed to be further validated.
The instrument uses digital microfluidics to provide rapid testing in multiple modalities, including RT-PCR, clinical chemistry, microbiology, and immunoassays, according to West, who noted that Finder can perform molecular diagnostic testing and clinical chemistry on the same sample at the same time.
The sample is placed into the instrument, which uses traditional reagents such as magnetic beads and PCR enzymes and fluorescence and absorbance to detect the target, and can return results in 15 minutes, he added.
The main difference between Finder and other microfluidics platforms is that Finder uses electrical fields, instead of pumps and valves and pipes used by other pressure-based instruments, to move the fluid through the machine, West said. The company converts assays into droplet format, which are moved through the device by turning switches on and off, he continued. The pumps and valves are like "analog electronics," and the circuit has one purpose and operates one way. There are no moving parts using digital microfluidics, increasing reliability as well.
The platform's protocols are based in software instead of hardware, which is why it can perform more complex tests, in terms of assay protocol, and makes it "so much more agile" than other pressure or channel-based fluidics machines, he said. By using electrical fields, the hardware doesn't need to be changed as the type of test changes.
The platform also has the capability to perform multiplex testing in multiple ways, whether by the classic method of adding different colors of fluorescence for different targets, or by its special method of "spatial multiplexing" — creating two droplets, each with some of the sample but with different reagents, and presenting them to the detector at different times, West said. As a result, the machine can "multiply the multiplexing that you get with a multicolor detector," he continued, which provides "further flexibility and capability."
The fast results and ability to multiplex make the platform particularly useful for sepsis, which kills about 1 million newborn babies each year, according to the World Health Organization. Rapid diagnosis of sepsis is essential, especially in neonates, because "if you can't find it early, there's not a whole lot you can do," West said. Clinicians often don't know what's causing sepsis and want to rapidly identify whether the cause is viral or bacterial. If bacterial, identifying the type of bacteria is also important in order to determine what antibiotics will work, he added.
Finder, West said, will be able to perform host-response testing, identify the type of bacteria causing an infection, and address bacterial susceptibility to antibiotics. The company will also integrate bacterial culture into the process, allowing users to take small subsamples of the culture and perform PCR and typing approximately every 30 minutes, West said. That way, clinicians can "get [the] answer as soon as those bacteria appear."
The blood culture is integrated with the consumable in one cartridge, which West called a "relatively simple engineering feat." As a result, culturing will take hours rather than days, he added.
The speed of diagnosis is the instrument's main selling point, at least for sepsis, but the ability to integrate culture is an added benefit, West said. And once the company puts an assay on the platform, primers and probes can be added easily to make the test translatable from one disease indication to another within the same modality.
Another benefit is the relatively small sample type required, since neonates can't provide the same volume of blood as an adult.
However, Ronald Wong, a senior research scientist in the pediatrics department at Stanford University who authored the Seminars in Perinatology study, noted via email that at the time of the project, the cost of the device and consumables wasn't know, so it could potentially be cost-prohibitive.
Finder will run users a few thousand dollars per instrument, although West said the company will offer multiple different models for customers, such as reagent rentals.
Wong also mentioned that the company's ability to manufacture enough devices and supplies was in question, because there were some quality control issues during the study, due to the company building an in-house cartridge manufacturing facility. The quality control issues "led to an increased number of cartridge failures and error codes," Wong said.
While the instrument is completed and available for sale with the SARS-CoV-2 test, there are many specific assays of interest Baebies is looking to develop, West said. While he said the company doesn't consider the development of these tests, including the pediatric sepsis test, "too difficult," Baebies will be "at this for a while" and doesn't expect the sepsis test to be available until 2023.
Beyond its G6PD and heparin monitoring tests, the firm also has planned "a couple of other jaundice tests," such as a syndromic panel for jaundice including total serum bilirubin, unbound bilirubin, and G6PD, West said. The panel will likely be ready for launch in late 2022 or early 2023, he said. Japanese firm Atom Medical will be taking Finder and the jaundice-related tests to market in that country, and Baebies is doing pilot testing for the G6PD test in Saudi Arabia, where the test was approved by Saudi regulators.
While Finder and the G6PD test are undergoing the 510(k) process, the firm is also awaiting EUA for its SARS-CoV-2 test on its Finder 1.5 platform. Development of Finder 1.5 to support RT-PCR testing was accelerated as a result of the pandemic with added heating control boards that weren't present on the original instrument, West said.
Finder 2.0, which will likely be completed in early 2022, will incorporate the features of both previous platforms and will eventually replace them. Finder 2.0 will also have enhanced detection capability, more flexibility with cartridge size and function, and will be capable of multifunctional tests on the same cartridge.
Part of the issue faced in neonatal intensive care units, West noted, is the lack of instruments specifically developed for babies with their specific problems in mind. Many NICUs have to use devices for adults, instead, and Baebies is looking to change that standard.
West did emphasize, however, that Baebies' products can be used in a variety of ways and are "equally relevant to the adult market, and so we're not limiting our future. We're just using the additional differentiation of having this neonatal focus so that we can have a good start."