NEW YORK – Age Labs, a Norwegian diagnostics company that specializes in developing tests related to aging, has decided to use its expertise in data analysis and machine learning to craft a new test for SARS-CoV-2, the virus that causes COVID-19.
The Oslo-based company plans to develop a test that can identify high-risk individuals based on an epigenetic signature. With the ability to triage patients at risk of developing severe disease, the company believes its test could be used to guide treatment decisions, not only in its home market of Norway, which according to the World Health Organization has reported roughly 9,000 COVID-19-related cases and 250 deaths, but in adjacent Sweden, which has reported nearly 80,000 cases and 6,000 deaths since the virus was first identified late last year, as well as in other hard-hit markets, such as the US.
"As we see it, this is not over at all," said CEO Espen Riskedal. "It's hard to predict who will have a serious outcome, so any sort of diagnostic that can help clinicians early on in making treatment decisions is needed," he said.
Riskedal cofounded Age Labs three years ago to develop a test for biological age and age-related diseases based on epigenetic signatures harvested from Illumina methylation array data using machine learning tools. The company has also capitalized on access to Norwegian biobank data, including blood samples and electronic medical records in the Scandinavian country, which stretch back decades. Initial versions of the test have been developed, Riskedal said, but it is still being refined using data from international biobanks as well as local partners in Norway.
The company received €1 million (about $1.1 million) last year in R&D funding from the Research Council of Norway to support the development of a unique biomarker for aging.
"Essentially, we do a blood draw, or use a dry blood spot and run this through the [Illumina Infinium MethylationEPIC BeadChip], which gives us nearly a million methylation values," said Riskedal. "We then use different machine learning techniques to make predictive algorithms," he said. The company does not intend to deploy its test on an array platform, but rather transfer them over to a more scalable, laboratory-friendly technique, such as PCR.
"In order to put this into the clinic, there has to be some kind of standard test to make the necessary predictions," he said.
The company was moving ahead with its test development pipeline when the pandemic hit and saw its experience in looking for age-related epigenetic markers as a potential avenue toward developing a different kind of test for stratifying patients.
This month Age Labs announced it had received about NOK 8 million ($870,000) from the Research Council of Norway to support the development of a test. Partners at the Norwegian Institute of Public Health, the Lab for Dynamic Gene Regulation at Oslo University Hospital, the department of acute medicine at Oslo University Hospital, and the department of medicine at Bærum Hospital will also take part.
Two studies are planned. An initial retrospective study will look for epigenetic signatures in blood samples from COVID-19 patients with known outcomes using samples and data sourced from Age Labs' partners. Once a prediction algorithm is developed, the partners intend to run a prospective study at Bærum Hospital and Oslo University Hospital. Any test that will be developed will be done so with help from the Lab for Dynamic Gene Regulation, Riskedal noted. Several hundred samples will be analyzed as part of the study, and Age Labs expects a prototype to be ready by year end.
Still, the format any future test will take is still undecided.
"We really don't know yet what lab method will be used in hospital labs when it is being run," said Riskedal. While he hopes that a PCR platform will be used, he cautioned that measuring methylation sites "doesn't scale well on PCR machinery" and said there "is a gap between microarrays and PCR from both ends" when it comes to running these kinds of tests.Â
There has been some interest in developing epigenetic tests for SARS-COV-2 since the pandemic began. In March, Fluidigm announced it was collaborating with the Icahn School of Medicine at Mount Sinai to develop an epigenetic test on the South San Francisco, California-based firm's microfluidics platform for early detection of SARS-Cov-2 infection.
Anders Tveita, a clinician who will lead the patient inclusion at Bærum Hospital, noted in a statement that the test Age Labs is developing for stratifying patients is currently in need.
"The clinical course in patients admitted to hospital with COVID-19 is unpredictable, and some patients deteriorate fast," said Tveita. "Tools that may help us identify who will deteriorate at an earlier stage will be of great importance and enable us to improve the treatment of each patient," he said. Tveita could not be reached for further comment.
While infectious disease is a new area for Age Labs, and the project has siphoned off resources from the company's small, four-person team, Riskedal said it fits with the company's outlook.
"We are coming at this from looking at aging," noted Riskedal. "Age is a dominant risk factor" for COVID-19, he commented. "Imagine looking for patterns in epigenetics that predict severity of outcome combined with prediction of biological age," he said. "We have all the necessary ingredients to really make something here."