Attana implements organizational changes and accelerates the development of Attana Diagnostics with COVID-19 tests leading the way

Attana can today announce that the company has strengthened its collaboration with the Linnaeus University to accelerate the development of unique antibody tests for COVID-19. Furthermore, the company moves forward with the regulatory efforts for AVA™ and implements a number of organizational changes aimed to establish an expert team leading the diagnostics initiative independent of Attana's ongoing operations. 

Strengthened collaboration with the Linnaeus University
The Linnaeus University in Kalmar installed its first Attana instrument as early as 2003, and in 2019 the university was granted funding from the Swedish Knowledge Foundation to in collaboration, with amongst others Attana perform research with ultra-sensitive sensors. 

Attana can today announce that the company, within the framework of the above-mentioned project, will deepen its collaboration with the university. Attana will dedicate an applications specialist with a background in immunology to optimizing Attana's diagnostic platform's existing test for analysis of antibodies and immunity to SARS-CoV-2. 

This antibody test is expected to not only provide with binary yes or no answer to whether an individual has developed antibodies or not, but also the concentration and quality of these antibodies - something that Attana and the Linnaeus University could be the first ever to offer. The purpose of such a nuanced test is to eventually be able to draw conclusions about individuals' level of immunity. 

The research going forward is expected to determine exactly which components the AVA™ test kit should include and which test protocol the diagnostic platform should proceed with in order to obtain regulatory approval.  

Regulatory progress
In December 2020, Attana announced that the company had completed a Medical Device Class 1 listing of Attana Cell™ 250 and a facility registration of Attana at the U.S. Food and Drug Administration (FDA), see here (https://news.cision.com/attana/r/attana-completes-fda-medical-device-class-1-listing-and-facility-registration,c3256535) for previous press release. This listing and facility registration were the first steps towards marketing Attana's instruments towards the clinical diagnostics market in the US. 

Attana has now hired the necessary external regulatory expertise working towards the submission of a so-called EUA (Emergency Use Authorization) application for its antibody test, read more about an EUA here (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev). 

In addition, the company is working to obtain the necessary CE-marking allowing the company to sell the test to clinical laboratories within the EU. The CE-marking is expected to be obtained relatively quickly, while an EUA is more demanding even if the application process is faster than that of ordinary FDA approvals. 

Organizational changes
As a next step, a number of organizational changes will be made aimed to establish a self-sustaining team running the diagnostics efforts independently of Attana's ongoing operations within drug development. 

In June 2020, Attana announced that Samir Fostock, Attana's co-founder, has been hired as a senior advisor for business development. The company can now announce that Samir from February has joined full-time as head of the diagnostics initiative. Samir's position will allow Attana's CEO, Teodor Aastrup, to fully focus on Attanas core business - being contract research and sales of instruments for drug development. 

Niklas Carlsson, who joined as COO in 2020, will leave the company and be replaced by, among others, Anna Sundqvist, who will take responsibility of HR and internal processes. In addition, Attana has initiated a recruitment process for new applications specialists with previous experience in CRO and hired a consulting firm to further strengthening Attana's sales and offering in pharmaceutical development. 

In summary, these organizational changes are expected to enable an accelerated development of the diagnostics business area without straining the resources of Attana's regular operations and compromising its growth. 

Teodor Aastrup, CEO of Attana, comments:
"The collaboration with the team at the Linnaeus University have been very rewarding and we are now looking forward to advance the development of this unique antibody test. Moreover, we are pleased to announce that Samir Fostock is returning full time. Samir and I know that we work great together and his role will allow me to focus fully on sales and the core business" 

In short, we are thrilled to have everything in place in order to gun - both with the diagnostics initiative and with the core business."