CE mark for Nightingale Health’s home test kit

Original comment published in Finnish on 10/7/2021 at 12:27 pm.

Nightingale Health announced that its home test kit has obtained the CE mark. The kit is used for the company’s home test solution. The at-home blood collection kit is CE marked under the category of in vitro diagnostic medical devices, and the CE marking covers the packaging, the equipment used for the blood collection and instructions for use.

Previously, in its home test pilot, Nightingale distributed the at-home blood collection kit in its at-home pilot under the CE marking registered by the device manufacturer (Weavr Health). According to the press release, the CE mark registered by Nightingale enables the company to operate more independently and rapidly when scaling its at-home solutions to different international markets. According to the company, it can now make changes to the product according to a flexible process, which makes it possible to adjust to the needs of different markets and business partners.

One of the objectives of Nightingale for the fiscal year beginning in July is the launch of a service based on home-testing. We believe that the company’s own CE mark registration is a positive step toward achieving this goal, but its impact on the company's investment story is limited in the big picture. We believe that the key to Nightingale’s story progressing is to build a growing business based on existing partner agreements, validate customer demand with the development of preventive healthcare services and enter into new large-scale international business partnership agreements. We will gradually have better visibility to these steps over the next few years.