About

BIOPIX-T is a company that was founded in 2019 with the aim to become a Medical Device Designer and Manufacturer of portable molecular diagnostic devices for Point-of-Care and Home testing. The first product that was launched was based on a methodology that was developed by its founders at the Biosensors Lab of the Institute of Molecular Biology and Biotechnology (IMBB) at the Foundation for Research and Technology -Hellas (FORTH).

In August 2020, BIOPIX-T was granted the necessary fund through a European Call (H2020), in order to immediately certify and deploy its device together with the accompanying tests for COVID19 and Influenza A.

At the same time, in September 2020, BIOPIX-T was funded by Metavallon VC, Eleven VC and a group of Greek healthcare related private investors to support its market entry efforts.

The company became fully commercially active in October 2021 by introducing into the market, its certified (CE-IVD) Molecular Diagnostic Platform for the Point-Of-Care named "PEBBLE" and the Compatible test kit for the detection of SARS COV2. Soon after the respective test kit for the detection of Flu A was also certified and introduced into the market.

Solution & Product

Background:
New trend in molecular diagnostics requires to have the actual diagnostic assay at the location where a sample is collected or patient is treated.
The “Point-of-Need” diagnostics in turn requires simple, rapid and cost-effective methods that could be performed not only outside the traditional lab environment but in any place and under any circumstances, such as in remote and isolated areas or even in space. A further trend towards “Personalized Medicine” requires diagnostic devices at the doctors’ office, through which the patient’s genetic compatibility to the proposed course of therapy will be checked.

Solution:
Our new device "PEBBLE qcLAMP Platform" introduces a novel methodology for the real-time colorimetric detection of DNA during isothermal amplification. This method offers radical improvement in point-of-care testing by allowing the combination of portability with the accuracy and sensitivity of the golden standard lab-based molecular diagnostic tools. Moreover, the device is inexpensive, easy to manufacture and can be operated by non-expert staff through an Android device. It weighs under 350 grams and can also run on a battery.

The company targets three categories of buyers namely, i) clinicians for infectious diseases screening, ii) clinicians for companion diagnostics, and iii) individuals for home testing of infectious diseases.

Innovation & Scalability

Our device provides its users for the first time with real-time quantitative information from a colorimetric LAMP reaction (qcLAMP) – which was until now an end-point detection method.
It converts the, so far, eye-based detection to a digital signal interpretation and performs real time analysis without the use of standard expensive fluorescent labels and filters (e.g. as in PCR).
Its sensitivity, reliability and speed is similar or better when compared to lab-based diagnostics devices, at a lower cost than other real-time portable devices. Depending on the application it can amplify and read up to 6 samples simultaneously.
The maximum time required to confirm a negative sample per run is less than 30’ but a positive sample may be detected much sooner (even in under 15'). Given that the device is a platform, any number of tests could be developed for applications not only in human healthcare but also in food, plants and industrial uses.

Traction & achievements

The company has received a lot of media and commercial attention. Distributors from all over the world have expressed interest in representing our products. Moreover, the company has already signed agreements with a South African Medical Company for the manufacturing and distribution of its products though out the Sab-Saharan region.

Our proposal to the EU covid19-response call, was one of the 23 out of 454 proposals which got funded. Partners to this proposal and responsible for the clinical validation of the test kits for COVID19 and INFLUENZA A were the, University College London Hospitals NHS Foundation Trust UK, Institut National De La Sante et de la Recherche Medicale France, and Universite Libre de Bruxelles in Belgium. From the market entry of the PEBBLE and the compatible test kit for Covid19, in October 2021, until October 2022, more than 150 devices have ben sold and more than 40K test have been successfully performed.

Team & Why Us

BIOPIX-T business plan is based on three revenue streams. Firstly, the sale of the diagnostic platform, and under a razor-and-blades model, the sales of the dedicated test kits, as even before the pandemic the biggest expansion in the diagnostics market was expected from the side of the consumables. Thirdly, being the only real time colorimetric isothermal platform, it operates uniquely a marketplace model, where third parties can run their own detections kits for an access fee

The current competitors’ landscape is dominated by either large lab-based devices or expensive less portable point-of-care devices. New competition has sprung up during the pandemic which has not been able to address both cost and portability, whilst maintaining a high level of accuracy. There are only a few devices that are truly portable and cost effective but suffer on quality and do not offer quantitative information. Our device can compete on price with any Point-of-care or home testing device due to its very low manufacturing cost, and can compete on quality with any real-time point-of-care or home testing device due to its very high accuracy and ease of use! BIOPIX-T aims to enter the Point-of-Care for infectious diseases in the first quarter of 2021 with the tests for SARS-CoV2 and Influenza A. Within the next four years it is envisioned that the PEBBLE will be complemented by a number of other tests for infectious diseases, as well as for companion diagnostics.

Funding Needs

The company currently runs a Series-A round , of up-to EUR5M, in order to:
a) increase headcount and scale-up production to meet current high demand
b) cover the costs of registering the IP in multiple markets,
c) implement aggressive marketing
and finally
d) speed up the R&D and productization of follow-on technologies and test kits, which have been planned but put on hold due to limitation of resources.