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Scienion, Pictor Developing High-Throughput SARS-CoV-2 Antibody Testing System

NEW YORK – Scienion said on Tuesday that it has entered into a strategic collaboration with diagnostic biotechnology company Pictor to commercialize a high throughput SARS-CoV-2 antibody testing system.

Financial terms of the deal were not disclosed.

Under the terms of the collaboration, the companies will incorporate Scienion's CL2 SciReader colorimetric microplate reader into Pictor's PictArray SARS-CoV-2 Serology Test to create a platform capable of testing for both anti-nucleocapsid and anti-spike antibodies in one reaction. The highly automated, miniaturized, multiplex immunoassay test will come in a 96-well plate format, the partners said.

The system will also use software developed by Pictor to produce a risk score for individuals to determine their likelihood of carrying a COVID-19 infection. This analysis, the companies said, will measure the population's level of herd immunity through natural infections and vaccinations.

The miniaturization of the assay is part of Scienion's focus on miniaturizing multiplex assays for diagnostic applications. According to Erik Gatenholm, CEO of Scienion's parent company BICO, the firm is looking into developing different cell-based assays and working with miniaturization techniques to try to reduce the size of reactions in order to save money for its customers and users around the world.

In a recent interview with 360Dx about the reorganization of Cellink into BICO, Gatenholm further noted that Cellink had acquired in May a company called Nanoscribe that specialized in using two-photon polymerization technology "to print very, very small substrates. So, if you think of tiny little wells where you can place human cells, they could help us print even smaller wells so that we can make even smaller reactions for it for [various] applications."

In a statement on the collaboration, Pictor CEO Thomas Schlumpberger said that adding the SciReader's high performance and accuracy to Pictor's test will enable the company "to bring high throughput, high performance, and low-cost multiplexed antibody testing for SARS-CoV-2 to the market … to provide insights into the epidemiological spread of the virus to help inform control and prevention measures."

The partners will enter the PictArray SARS-CoV-2 Serology Test into clinical trials in coming weeks, with the goal of applying for Emergency Use Authorization from the US Food and Drug Administration and bringing it to market in early 2022. The companies also plan to pursue a positive opinion from the Committee for Medicinal Products for Human Use for use in the UK and the European Union.

The role of tests that detect antibodies against SARS-CoV-2 have been put into question in recent months, however, as the FDA posted a notice in May advising against the use of SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19, including after vaccination.

"Antibody tests can play an important role in identifying individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response. However, antibody tests should not be used at this time to determine immunity or protection against COVID-19 at any time, and especially after a person has received a COVID-19 vaccination," Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, wrote in the notice.

The agency also noted that authorized vaccines for prevention of COVID-19 induce antibodies to specific viral protein targets and that post-vaccination antibody test results would be negative in individuals without a history of previous natural infection if the test used didn't detect the type of antibodies induced by the vaccine.

Despite this, the companies believe that their combined technologies will prove to be a game-changer.

"While FDA currently does not recommend using antibody tests to assess individual immunity status, the agency does use the data in determining the efficacy of vaccines seeking approval," the partners said in a combined email statement to 360Dx. "The platform is intended to help public health officials and researchers by providing them with large-scale antibody data that can be used to determine herd immunity levels and support decision-making. By testing both anti-nucleocapsid and anti-spike antibodies in one reaction, we can arm the FDA, CDC, and other researchers with a better understanding of how populations are protected by antibodies from natural infections and vaccinations."

They also noted that the software Pictor has developed to determine risk scores at the individual level will only be used in geographies that have approved its use.