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With a New Name, Metabolic Dx Firm Nightingale Preps for Market Launch

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NEW YORK (360Dx) – Three years after its founding and with a new name in tow, Nightingale Health is poised to move into the clinical market with technology that it said can provide information on 220 metabolic biomarkers for chronic diseases.

Based on nuclear magnetic resonance spectroscopy, Nightingale's technology has so far been available for research use only. But later this year, the Finnish company, formerly called Brainshake, anticipates getting CE marking for its test and then launching it in that country, its Cofounder and CEO Teemu Suna said in an interview. Longer term, it plans to seek regulatory approval from the US Food and Drug Administration, he added.

For now, the test is aimed at assessing a patient's risk for developing diabetes and cardiovascular disease, but the technology may have diagnostic applications for brain-related illnesses, such as Alzheimer's disease, that have been implicated in metabolic syndromes, Suna said.

From a patient's perspective, the Nightingale test, which so far has no name, would be administered in the same way as a cholesterol test. A blood sample is drawn, then sent to a lab, and a few days later a clinician would receive results to review with the patient.

"If you look at global healthcare, we think that it's not actually healthcare, but it's rather sick-care," Suna said of Nightingale's clinical proposition. "What we are mostly doing, and if you look at the costs in healthcare, it mostly comes from treating sick people."

Instead of such an approach, a more efficient model, he said, would be to prevent disease by trying to predict it before symptoms arise in a patient. That's what Nightingale aims to do.

Among the 220 biomarkers that the company's platform measures are cholesterol, fatty acids, apolipoproteins, ketone bodies, amino acids, and others. The workflow is as follows: After a 350 microliter sample of serum or plasma is collected and sent to a lab, the samples are transferred into NMR measurement tubes where solvents are mixed in. According to the company, the sample is never in direct contact with the NMR detection, resulting in cost-effectiveness, stability, and robust biomarker quantification without batch effects.

Proton NMR spectroscopy is then performed, quantifying more than 200 metabolic biomarker measures per blood sample. Fully automated sample changing, temperature control, and advanced NMR spectroscopy leads to spectral data — which describes the structure of the blood sample — that can be analyzed, Suna said.

He noted that the firm's proprietary bioinformatics software quantifies that data in molar units, a capability that differentiates Nightingale from a competing technology, mass spectrometry, which Suna said does not provide absolute concentrations.

As a result, data produced by Nightingale's method can be analyzed in the same manner as other clinical chemistry data, with no expertise in metabolomics required.

"For example, if we measure LDL cholesterol with our technology, it is directly comparable to LDL cholesterol with clinical chemistry, [so] we have a real medical baseline because of the absolute concentrations," Suna said.

Although the technology provides 50 times more biomarker data than current lipid tests, the price of the technology is approximately the same as that for a cholesterol test, about €10 ($10.66), he said.

Nightingale is also developing a risk-profiling tool that can provide a clearer picture of a patient's health status in relation to diabetes and cardiovascular disease. Rather than overwhelming the clinician with data for all 220 biomarkers, the tool would categorize patients into low, middle, or high risk for developing the disease.

Suna also said that because Nightingale's research collaborations have supplied it with data from different ethnicities, the firm can tailor its risk model to different ethnic groups. "And that's one of the major changes that we are driving — that it's not one-size-fits-all," he said.

In one study, published in Diabetologia in May 2015, for example, researchers from Nightingale, the UCL Institute of Cardiovascular Science, Imperial College London, and other schools reported finding "ethnicity-specific data regarding the associations between amino acids and incident diabetes." In particular, they said that levels of branched chain and aromatic amino acids, especially tyrosine, were more adversely associated with incident diabetes in South Asian men than their European counterparts.

Nightingale is currently preparing its test for CE marking, and it expects receiving the designation in "less than two months," Suna said. Afterward, the company will launch the test in Finland.

It plans to make the technology available through its own laboratory as well as through other labs. Nightingale has an existing facility, which the company is in the process of getting ISO-certified to handle clinical samples.

Nightingale also plans to make its equipment available to outside laboratories to run its test, Suna added. The company would install the NMR instrument in a customer's lab as part of a service contract, so there would be no capital expenses for the customer, who would pay only for the measured sample.

The firm anticipates starting a pilot study before the summer with blood samples from up to 500 patients to demonstrate the utility of its risk-profiling tool. A follow-on study focused on routine use of its technology by cliniciansis also planned, with "a couple of thousands" of samples to be included, Suna said.

The company has started a project to assess the most efficient way to enter the US market, and while it plans to pursue FDA approval, it has not determined whether to go for 510(k) clearance or premarket approval, Suna said.

Going clinical

As Nightingale primes itself for the clinical market, Suna said the firm now has the science to back up its ambitions.

"We have quite a lot of proof that the biomarkers that we use can improve the … understanding of disease risk," Suna said. The company cites more than 100 peer-reviewed studies that support the science behind its technology.

A study published two years ago in Circulation: Cardiovascular Genetics described the automated high-throughput serum NMR metabolomics platform Nightingale developed. In it the researchers said their results "revealed new biomarkers for early atherosclerosis, type 2 diabetes, diabetic nephropathy, cardiovascular disease, and all-cause mortality."

In another study published in Circulation two years ago, researchers used Nightingale's technology to identify biomarkers for incident cardiovascular disease and concluded that high-throughput metabolomics can be a valuable tool for "biomarker discovery and improved risk assessment."

Suna noted that the studies don't confirm the clinical use of the company's technology.

As Nightingale prepares it for the clinical market, one of its research partners said that he'd like to see the company's test cover even more metabolites. "In general, mitochondrial diseases are fascinating to me, and I probably think they're more broadly present," Open Medicine Institute Director and CEO Andreas Kogelnik said in an interview. "But inflammation post-infection and that kind of inflammatory response, there are a lot of molecules there that I'd love to see more coverage on. But the coverage is already quite good."

The Open Medicine Institute has been using Nightingale's technology for about a year to evaluate its performance along with those of other omics methods, he said, adding one advantage of the company's platform is that allows for results to be looked at longitudinally, "because the cost is so low. You can take a sample and then do an intervention and then go back, and look at it again."

Suna said that moving the technology into the clinical arena will require no changes to it. "The technology is used in epidemiological studies. It's been used very much like it would be [if] it were a clinical technology … so the fundamental technology remains the same," Suna said.

He added that he doesn't believe Nightingale has any direct competitors to its technology. Some mass spectrometry firms, notably Metabolon, provides biomarker profiling services, but he said that Nightingale's service will be considerably less expensive per sample. "We are more targeted to clinical use, whereas mass spectrometry is more targeted to pharmaceutical R&D, for example," he said. 

In an email, however, Metabolon CEO John Ryals said that NMR can measure only "a very few small, non-proteinaceous molecules," and only at very high concentrations, "so it has limited sensitivity for use in diagnosing disease. In fact, NMR would not be able to replicate the applications that we have already developed for the clinical space."

Metabolon's mass spec-based methods can measure approximately 1,400 individual biochemicals in a plasma sample, "providing robust information for clinicians. This level of sensitivity is necessary to accurately identify disease indicators (especially in their earliest, treatable stages) and nuances in an individual’s health status," Ryals added.

Regardless, as Nightingale prepares for its new clinical aspirations, it has no intentions of leaving the research arena. The science "has been the backbone for this company in the past and it will be also in the future," Suna said.

Along with Suna, Nightingale's cofounders include Antti Kangas, now the company's chief technology officer; Pasi Soininen, the laboratory director; and Peter Würtz, the scientific director.

In 2016, Nightingale posted €1 million in revenues and ended the year at break-even. Since its founding, it has raised a total of €7.5 million in funding, including €5.5 million in the second half of 2016. For its next funding round, which is slated to begin in about a month, the company has targeted €30 million, Suna said. The new funds will be used to commercialize Nightingale's technology.

"What we are developing is a solution for a global challenge, which is chronic diseases," he said. "Chronic diseases are the biggest cause of deaths in the world and a huge economic burden. We believe we have a technology that can actually change the world, how chronic diseases are treated."