Introduction

Explanation of symbols

Introduction

This document provides general information and procedure to use VarSome Clinical, available by using the following URL:

⚠ CAUTION These Instructions for Use (IFU) contain important information for the safe use of this product. Please read the entire IFU before using our product.

Manufacturer:

Saphetor SA
EPFL Innovation Park – C 1015 Lausanne
+41 21 552 09 77
www.saphetor.com / www.varsome.com

Authorized Representative

Saphetor SA Greek Branch

Leocharous 3 - Athens 105 60

Greece

Result Validation

We can provide detailed validation results for known individuals whose cells/DNA can be ordered by post here.

The samples should be run through normal laboratory procedures. Then send us the FASTQ files, and we will validate the variants against the Genome in a Bottle (GIAB) dataset giving detailed specificity and sensitivity.

Regulatory Information

According to the Annex III of the European Directive 98/79/EEC, VarSome Clinical is considered as an In-Vitro Medical device.

The use of VarSome Clinical is subject to the terms and conditions provided on our website. Please consult them.