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Finland's Negen Introduces Pharmacogenomics Panel for COVID-19 Therapies

NEW YORK – Finnish genetic testing firm Negen has rolled out a pharmacogenomics panel designed to help guide decisions in treating patients with SARS-CoV-2. The Helsinki-based firm is making its panel available for free to people who already have been genotyped by consumer genomics services or biobanks.

CEO Kirsi Auro said the company decided to make its panel free for people who have their own data because the nature of the coronavirus pandemic has led to a slowdown in producing genotyping data, and because the data the company provides could be immediately actionable.

"We are living in quite peculiar times with the COVID-19 situation globally, and as information on the drugs that are used to treat the infection accumulated, we realized some of these medicines do have quite significant pharmacogenomics involved and this information could potentially be extremely relevant for the patients but also of course for hospitals," said Auro.

"We chose to accept data that is already readily available because producing new genotyping data takes a while," she said. "With this data we can do the analytics quickly and the person can get the results within the day."

Some of the medicines that are currently being considered for treating the SARS-CoV-2 virus include chloroquine, hydroxychloroquine, a Lopinavir/Ritonavir combination, and Anakinra. As Negen notes on its site, pharmacogenomic effects have been described for all of these therapies, particularly for the anti-malarial drugs chloroquine and hydroxychloroquine as those who have G6PD deficiency are predisposed to hemolytic anemia.

In addition to targeting G6PD variants, the panel also targets variants for SLCO1B1, which may indicate decreased tolerance for Lopinavir, a therapy used to treat patients with HIV, as well as elevated risk for adverse effects, in addition to interleukin 1 (IL1) variants, which are associated with adverse effects in those receiving Anakinra, a drug used to treat rheumatoid arthritis.

It's unclear if any other company is offering a similar pharmacogenomics panel tailored to COVID-19 treatments in Europe at this time, though individual tests are available for different variants from a host of players. Auro said that the reason competitors might not have put together similar panels is because it's early in the pandemic and producing new tests takes time and resources. "As a small company we are quite agile and we have the ability to target our efforts toward something new quite quickly," said Auro. "This is what we have done."

CTO Kimmo Aro said there are smaller panels on the market for these specific variants — Invitae and 23andMe both offer G6PD deficiency testing, for instance — but Negen decided that given the health crisis it made sense to bundle them into a single panel.

"We thought that as many people as possible should have this information," said Aro. "We decided to make it free for individuals who have their own data as the cost for us producing it is not big when we don't need to genotype these samples."

Negen was founded in 2016 to design genome risk panels for the Finnish population. "We noticed that potential risk panels produced in the US didn't necessarily fit accurately to Finland or some other populations," said Auro. The privately held company's focus has been to start in Finland and then expand to other populations, taking this population-tailored approach.

"We wanted to be as scientific as possible to produce polygenic risk scores and combine them with single clinical variants for different diseases and also bring in some environmental risk factors," said Auro. The company's first product was a panel for coronary heart disease called Negen - Heart. It has also developed and launched a second panel for diabetes called Negen - Diabetes. A third offering, Negen - 360, combines both panels into a single product.

The company relies on custom Illumina genotyping arrays to generate data on its patients. Its two standalone panels cost €239 ($258) each, while Negen - 360 retails at €349. A panel for breast cancer is also in development. Customers who do not have their data at present can also opt to be genotyped for the new pharmacogenomics service from a saliva sample for €179. However, given the current situation, Auro cautioned that laboratory processing has been delayed.

In terms of data submissions, the company is currently accepting data files from 23andMe, Ancestry, MyHeritage, and Family Tree DNA on its site. While not every chip used by these services contains the markers included in Negen's panel, they more or less have the same backbone of coverage as Negen's own custom Illumina array. Negen can therefore impute the necessary data to enrich it and then calculate its models. "This is something we can do outside of the COVID panel and this something that is part of our pipeline," said Auro.

Consumer genomics has not been unpopular in Finland, though it is dwarfed by uptake in the US. Auro said that about 20,000 Finns have such data available out of a total population of around 6 million. People who have already been genotyped or whole-genome or whole-exome sequenced by a biobank can also upload their data and receive results. Finland currently has a genotyping initiative underway via FinnGen, which aims to genotype 500,000 Finns by 2023.

The company itself relies on biobank data to design its panels, and so data acquisition is not a target of the new offering, though if it does intend to use any customer data, it obtains their permission first and all data analyzed is protected by the European Gene Data Protection Regulation as well as national regulations.

"It's been of interest in Finland," said Auro of the new panel. "The first day it was available, we received several hundred requests [for analysis]," she said. While the company launched the test in Finnish earlier this month, it is now in the process of expanding to reach international users by making it available in English.

"We know that in Finland, the percentage who owns their own whole-genome data is limited," said Auro. "We wanted to expand and see how this test could be delivered to global markets." When asked if the service could help the company reach more customers with its other panels, Auro agreed. "We do believe this will help us reach more international customers for our other tests," she said.

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