Miniaturized thermocycler for POC system
Challenges and Solutions
Pneumonia is the first cause of death in children and elderly and diagnosis remains a challenge. The existing methods are either unreliable or too long. It generates many false positives and negatives or require 24 to 48 hours after which the patient’s life could be at risk.
Alphasip, a Spanish SME, is validating a system that aims to deliver a diagnostic of pneumonia in 2 hours.
In AlphaSIP’s system, thermal management to perform PCR heating and cooling cycles is a core subsystem. The subsystem delivered by IK4- Ikerlan consists of a miniaturized thermal management system, inclusive of detection, for the thermocycling has proven to be faster, reliable and affordable.
The Gateone-project is part of SAE initiative and acts here as an Accelerator, allowing a fast match from the existing capabilities and developments at IK4-Ikerlan, consisting in this case of a miniaturized thermocycler module, and the needs of the company. The investment decision process was fast and helped to close the gap between the existing device and the real application, funding the small adaptation required to enable a risk release with a series of tests performed by the company by its own expert in an open innovation framework.
AlphaSIP’s plan is to enter the market with reliable and easily recognizable technologies that contain a substantial degree of innovation. For this reason, the first product will be a desktop device that has a very robust performance and that can be easily tailored for many indications, combined with a miniature and modular innovative thermocycler. This will be the company’s first step towards a smaller and faster system.
The system will be sold with consumable cartridges at a target price of 20 to 30€ each. The product should hit the market in 2017 after covering the following step: Development, Industrialization, Preclinical tests and Clinical tests.
It is estimated that PoC systems would increase the revenue of AlphaSIP by 2,25M€ over the 5 years after market entrance only in Pneumonia. Other indications are already being developed which could multiply this figure. The estimated entrance of a PoC system into market is expected in 2018-2019.