NEW YORK – Having collected data on more than 100,000 individuals, including healthy controls and subjects with a variety of diseases, metabolomics testing firm Lifespin is now looking to target the US and European diagnostics markets.
The Regensburg, Germany-based company is using its NMR-based platform to develop tests for a variety of conditions, with its main focus being cancer and neurological diseases. Lifespin CEO Ali Tinazli said the company is currently developing products for aiding the diagnosis of multiple sclerosis and Parkinson's disease as well as several cancer subtypes and aims to bring a laboratory-developed test for one of the conditions to market in the US in the next 12 to 24 months.
To support this effort, Lifespin plans next year to raise a Series A funding round in the range of "double-digit millions" of dollars, Tinazli said.
The company is also one of the 17 inaugural members of the newly formed Industrial Participant Program at the Wyss Institute's Diagnostics Accelerator, which aims to drive development and commercialization of new diagnostic technologies. Tinazli said that the company's participation in the IPP is part of its efforts to develop its US presence in advance of its planned LDT launches.
Tinazli joined Lifespin as CEO in July. He was previously senior director, head of healthcare and life science strategy at HP and head of business development and sales at Sony DADC BioSciences Americas.
Founded in 2017, the company was operating in stealth mode until September of this year, Tinazli said. The core of Lifespin's technology is software that enables highly automated processing of NMR metabolomics measurements, allowing it to generate large datasets it can use to explore human health and disease states.
NMR itself is also well suited to this task as the technology is inherently highly quantitative and reproducible. Additionally, sample preparation processes are relatively simple.
Tinazli said that in the years before he joined the company, Lifespin scientists had generated NMR-based metabolomic profiles of around 130,000 individuals spanning a variety of disease cohorts.
The company "has a very large dataset [of subjects] at different ages and genders," he said, noting that this had allowed it to begin determining profiles for healthy and disease states across a range of populations.
"A [healthy] 20-year-old woman has a different profile than a healthy 60-year-old man," he said. "So it is very important to understand that the nature of health is not a static one. They are both in a different way healthy."
"Once you have determined these baselines, then you can now as a next step identify deviations of the metabolomes in patients with different indications," Tinazli said. He said that Lifespin is currently involved in studies with 20 different hospital partners looking at metabolomic alternations in various cancers and neurological conditions, including work with Berlin's Charité hospital on markers for diagnosing multiple sclerosis and Parkinson's disease.
Lifespin also offers its platform as a research tool for pharma collaborations, though Tinazli said its main focus is diagnostics development.
Gas chromatography- and liquid chromatography-mass spectrometry are the dominant tools in metabolomics, capturing around 80 percent of the market while NMR accounts for most of the remaining 20 percent. As previously noted, NMR has the advantage of being highly reproducible and quantitative with a simple sample prep process. Unlike GC-MS and LC-MS, it is also nondestructive, which means multiple analyses can be carried out on the same sample.
The technique is roughly 10- to 100-fold less sensitive than GC-MS and LC-MS, however, which limits the number and kind of metabolites it can measure and the concentration ranges it can analyze. A typical NMR metabolomic experiment, for instance, may measure in the low hundreds of metabolites in a concentration range of 1 μM and above, while mass spec-based methods can measure 1,000-plus metabolites in concentration ranges down to the 10 nM level.
Tinazli said that Lifespin's NRM analysis algorithm, called Profiler, boosts the number of metabolites the company can detect to around 1,000.
While NMR is less commonly used for metabolomics work than mass spec, several companies have developed or are developing metabolomic-based diagnostics using NMR. Finnish diagnostics firm Nightingale is developing health monitoring tools for individuals and businesses and is currently piloting a health monitoring metabolomic panel in Helsinki, where the company is based.
German metabolomics firm Numares, which, like Lifespin, is based in Regensburg (Tinazli said there is no relationship between the two companies), this year signed an agreement with Bruker to commercialize NMR tests. This followed a test development collaboration the company signed in 2019 with Mayo Clinical Laboratories. In 2017, Numares launched a test in Europe for monitoring kidney transplant patients for transplant rejection and said this year that it plans in the near future to launch an NMR-based test for identifying and monitoring patients with impaired kidney function. In 2014, Labcorp purchased LipoScience's NMR LipoProfile test, an NMR-based assay with US Food and Drug Administration 510(k) clearance that quantifies LDL particles in blood to help manage patients with cardiovascular disease.
Tinazli said Lifespin plans to approach both the US and European markets by working with lab partners that will offer its initial tests as LDTs, though he said the company would also look to establish a US presence.
Longer term, Tinazli said he envisions the company adopting a "software as a service" business model, where its primary product is access to its algorithms for processing and analyzing NMR metabolomics data.
"Our vision is that each laboratory that runs an NMR can access via cloud solutions our algorithms and then pay basically per test," he said. "We are not necessarily selling hardware; we are selling software."