Company Profile
40Pages

Stay Healthy, Live Better

2. History a. How we began b. OurVision 3. Mission a. OurValues b. Our Expertise 4. Strengths a. OurStrenghts b. R&D Department 5. Portfolio a. Worldwide distribution b. Our catalogue

About us. PRIMA® Lab SA is a modern Swiss company developing simple and precise certified diagnostic in vitro medical devices (IVD), for a rapid check of people’s health and their pets. Our Company has a fully in-house production cycle: from the studies in our laboratory to the final distribution. Prevention has never been so simple, handy and accessible to everybody and everywhere: in less than 10 minutes you can get an accurate answer about your health status, the one of your patients and your pet’s one. Stay Healthy, Live Better

PRIMA® Home Test includes all the self-tests for humans’ health – layman use PRIMA® Home Pet is the range of devices dedicated to the pet’s health – layman use PRIMA® Professional is the category of tests reserved for professional

How we began. PRIMA® Lab SA was born in 2014 in Switzerland, from a passionate idea of its founder. Since then the team has quickly grown from five original employees to the existing thirty, with almost 70% having a scientific master of science. Originally our core business was based on the distribution of IVD test and their online sales but, over time, we have become an R&D focused company and top quality manufacturer in the diagnostic field. Between 2016 and 2018 we invested to expand our laboratories and production areas. In 2019 we enlarged also our office spaces and we look forward to...

Our Vision. Our passion and hard work have brought us where we are now, characteristics that will certainly be part of our future. Our mission is still the same: providing medical devices to help people monitoring their health status and to avoid wasting both time and money. Furthermore, we want to continue supporting health care professionals in the rapid diagnostic of certain diasease by helping them to assist their patients through the time.

Swiss Quality Our products are made in Switzerland to the highest standards of quality Collaboration Relationships, inside and outside the Company, are essential for a good job Passion Our mission comes directly from a great passion in our daily work

Research & Development We build our products starting from the expertise of our laboratory Manufacturing A fully in-house production allows us to monitor the entire productive cycle Quality Management Our quality management system is certified by recognized Institutions

R&D Dept. Our Research & Development Department is considered the flagship of our Company. It was born in 2016, where our R&D team has produced their first test just one year later, on August 2017: the Celiac Test. Starting from that great result, we extended the inhouse production to all tests which we have been distributing since that moment. v3

R&D Dept. Research Grants During the last year PRIMA® Lab SA has won grants for three different innovative proposals, thanks to the knowledge of its R&D Department: 1. DSF – Digital Smart Fluidics, an industrial development project funded by Regione Lombardia, Italy 2. Innosuisse, two research projects in collaboration with HES-SO Valais – Wallis, Institute Life Technologies, Swiss University in Sion 3. ImmunoViral Test – Bando Regione Lombardia Misura COVID-19 in collaboration with Istituto di Ricerche Farmacologiche Mario Negri IRCC

NEW PRODUCTS PIPELINE Home & Professional use • Enhanced Cholesterol Rapid Test on WB - Strip • HIV V2 Test on WB/S/P-Cassette • PRIMA® Electronic Reader (just for professional use) NEW COVID-19 RAPID TEST PIPELINE Professional use • COVID-19 IgG Spike Test on WB/S/P - Cassette • COVID-19 IgA Salive Rapid Test on salive - Cassette • COVID-19 Antigen Rapid Test on salive - Cassette • COViX MolecularTest

R&D Dept. PRIMA® Electronic Reader Thanks to the collaboration with a partner Company, PRIMA® Lab SA has developed an electronic reader which allows health care professionals to easily process and interpret the result of a large number of tests, by recognizing the different intensities of the test lines, showing the obtained results on your computer screen in a few seconds. The Reader is under validation and will be available on the market soon.

Becoming a manufacturer has been a challenging moment for us. In 2019 we designed and installed a customized machine that allowed us to speed up the test production. We keep searching for new machines which can facilitate the work by making it as automatic as possible.

Quality Management. PRIMA® Lab SA has structured itself on the highest standards of Quality Management System, obtaining the following certifications, issued by MDC – Medical Device Certification GmbH: ü ISO 9001:2015 ü ISO 13485:2016

Quality Management. In particular, PRIMA® Home Test devices are all CE certified for self-testing by the Notified Body mentioned above, according to the European Directive 98/79/EC. View the last version at this link.

PRIMA® Lab SA has structured a worldwide distribution with a presence in almost all the continents and more than 30 countries in the world.

PRIMA® Home Test devices are totally in-house produced. They are all CE certified for self-testing and they can be easily performed in just 2-15 minutes by everyone, everywhere. These tests use different types of specimen: whole blood, serum, plasma, urine, faeces and others, like sperm, vaginal or throat swab.

Our Catalogue. PRIMA® Home Test – Whole blood, serum and plasma specimens

Our Catalogue. PRIMA® Home Test – Urine specimen

Our Catalogue. PRIMA® Home Test – Other specimens

PRIMA® Professional offers rapid tests for health care professionals, providing point of care analysis to improve their services.