Skip to main content
Premium Trial:

Request an Annual Quote

Biopix-T to Launch Point-of-Care Flu Test, Plans to Raise €6M to Support Test Pipeline


NEW YORK – Greek molecular diagnostics firm Biopix-T is seeking to raise about €6 million ($7 million) to fund efforts to nearly triple its headcount and develop several new tests for use on its point-of-care Pebble qcLAMP platform. 

Sergios Katsaros, head of commercial operations and finance for the Heraklion-based company, said the company also plans to obtain a CE-IVD mark for an influenza A assay by December. 

Biopix-T recently garnered a CE-IVD mark for a SARS-CoV-2 assay, which like the influenza A test, relies on its real-time quantitative colorimetric loop-mediated isothermal amplification, or qcLAMP, technology, and runs on Pebble, a 300-gram, handheld system that the firm is selling for €750.

Biopix-T anticipates increased demand for flu testing as more countries exit lockdowns during the ongoing COVID-19 pandemic. "Because of the lockdowns and restrictive measures for COVID-19, flu disappeared from the planet, not just Europe," noted Katsaros. "The fear right now is that the flu is coming back," especially as it's unknown what flu variant will be circulating and vaccines have not been developed for those variants, he added.

Biopix-T will sell separate assays for SARS-CoV-2 and influenza, but both tests can be run simultaneously on the Pebble platform, which can process six assays at a time, typically with a turnaround time of less than half an hour. Biopix-T's tests rely on nasal or pharyngeal swab specimens collected from patients.

Katsaros noted that its debut SARS-CoV-2 assay obtained a CE-IVD mark through a self-certification process under Europe's existing In Vitro Diagnostic Directive. Europe, however, is currently transitioning to a new IVD Regulation that promises more direct oversight of IVDs and mandates that most of them be evaluated by a designated certification body, called a notified body or NB.

Biopix-T has designed everything around its platform to be IVDR compliant, Katsaros said, but he pointed out that there is a long waiting list before an NB will look at the company's submissions. "The backlog of applications for IVDR is such that you have to wait in line for a year before you get audited," said Katsaros.

Currently, the IVDR is set to come into force in May 2022, but a proposal is under consideration that will allow CE-IVD marked kits prior to that date to remain on the clinical market in Europe through the mid-2020s, depending on their device class. However, those marked after May 2022, must still obtain certification via an NB under the IVDR, which makes it difficult to predict when its next assays will reach the market.

According to Katsaros, in addition to influenza, Biopix-T has several other assays in development. Three of them will be "infectious disease related" he said, while a fourth will be the company's first pharmacogenomic assay. He declined to name the indications but said the infectious disease panels would include some diseases transmitted human to human and others that are insect-borne. "We are targeting densely populated, developing countries," he said.

Biopix-T is also innovating on its test kit design. Katsaros said that both its SARS-CoV-2 and influenza A assays currently require freezer storage and the use of a pipette, but that newer test kits are in development that can be stored at room temperature and will be ready for use without a pipette. "This will take full advantage of the capabilities of our instrument and bring it from the near point of care to the true point of care," said Katsaros. He said the timeline for delivering the new test kits to market is, again, incumbent on NB capacity.

From Greece to the world

Biopix-T was founded in 2019 to market technology developed by researchers at the Foundation for Research and Technology – Hellas, or FORTH, based in Heraklion. The company currently maintains three sites around Heraklion, including administrative offices at the Science and Technology Park of Crete.

Earlier this year, its quality management system was ISO 13485 certified, an undertaking that Katsaros said established the credibility of the company. "Once you get the 13485, then you are a medtech company," said Katsaros. "You have the ability to talk to the World Health Organization if you want to." In August, Biopix-T also received ISO/IEC 27001 certification for the information security management system at its manufacturing site.

As a molecular diagnostics company, Biopix-T is rather uniquely placed geographically, headquartered on the island of Crete, the largest and most populous Greek island, which is better known as a tourist destination than a life sciences hub.

"We are not even operating close to a large center like Athens but on Crete where attracting the right talent is extremely difficult and expensive," acknowledged Katsaros.

He also said that attracting capital within the country has been difficult, as some Greek venture capital firms are not capable of providing adequate seed funding for scientific endeavors. Yet Biopix-T was able to get the interest of the European Union, which awarded the firm €2.4 million in Horizon 2020 funding last year to support the development and launch of its system and an accompanying assay for SARS-CoV-2.

The consortium included partners at University College London Hospital; the French National Institute of Health and Medical Research; the University of Leuven in Belgium; EnzyQuest, a Greek reagents company; Kiara Health, a Johannesburg-based pharmaceuticals and diagnostics company; and PKNM Solutions, a Swiss firm that assisted Biopix-T in several ways.

Katsaros credited PKNM with guiding the company through setting up its quality management system and obtaining ISO certification, as well as with supporting the firm with the development and commercialization of its products. 

"If we hadn't been funded by the Horizon 2020 call, it would have been literally impossible to get into the market at the speed we did," said Katsaros. 

Earlier this year, Biopix-T secured about €1.5 million in a round led by Athens-based Metavallon VC and Bulgaria's Eleven VC. The company is now planning another round for up to about €6 million.

In addition to test development, Biopix-T plans to increase its headcount. The company currently employs 13 people but would like to have about 40 employees by the end of next year, mostly involved in research and development, and manufacturing, as well as IT programmers and system engineers, Katsaros said. He added that Biopix-T has developed a cloud-based application for collecting and storing data from its devices that will be used to inform new tests.

In terms of competitiveness, Katsaros said the firm sees its qcLAMP approach as fitting between real-time PCR tests and antigen testing on the COVID-19 testing market. Biopix-T's approach is "faster than typical PCR, because it uses LAMP, so you don't need to go through the hassle of elevating and inducing temperatures, but it is just as accurate as PCR, but more cost effective as a device," he said. Katsaros said that PCR point-of-care devices can cost more than $4,000, while Pebble costs a fraction of that.

One target market for the company are smaller diagnostics centers around Europe. "Every pathologist's or pediatrician's office can become a point-of-care diagnostic center," said Katsaros. The company also plans to eventually test tests for any disease that may interest pediatricians and pathologists, and it is open to partnering with other firms to develop additional tests that could be run on Pebble, most likely in the areas of infectious disease or pathogen detection or pharmacogenomics.

Biopix-T has started to line up distributors to sell its platform worldwide. South Africa's Kiara Health, which participated in the Horizon 2020 consortium, is one of the firm's new distributors. Katsaros said that Biopix-T has performed technology transfer for its products to Kiara, which will allow the products to be manufactured locally in South Africa and distributed throughout sub-Saharan Africa.

Katsaros noted that Africa could be a "significant market" for Biopix-T "since there is a lack of funding and infrastructure," said Katsaros. Biopix-T's test pipeline includes assays "that relate to diseases that have been tormenting the region for decades."

In Europe, discussions are underway with partners that will enable Biopix-T to scale production and reach multiple national markets. He noted that the company had UK, French, and Belgian partners on the Horizon 2020 project that "should facilitate our market entry there," with more countries being considered.

The US and India are two large markets that are also of interest for Biopix-T. In the US, Katsaros said the company would be interested in finding local manufacturing and distribution partners and to set up a local presence. At the moment, the firm does not have the resources to pursue a US Food and Drug Administration clearance, he said. A market entry strategy for India, a developing, densely populated country of 1.4 billion, is currently being developed by the firm.