PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.

Genetic Signatures supplemented its existing assays to identify the SARS-CoV-2 virus using its real-time polymerase chain reaction (PCR) assay.

The new SARS-CoV-2 Detection Kit can be used on Genetic Signatures’ highest throughput instrument, the GS-1000, which can process about 1,500 samples in a 24-hour period in batches of 188 samples per run, Genetic Signatures CEO John Melki told BioWorld.

Global problem

When it became apparent that the COVID-19 outbreak was a serious global problem, Genetic Signatures directed its resources to develop a SARS-CoV-2-specific test using its 3base technology.

“The COVID-19 pandemic is being fought on multiple fronts, and our new molecular test will give health care workers in Europe a high-throughput and accurate diagnostic solution to help combat this virus. It is a significant achievement to attain registration so quickly,” Melki said. “It’s an exciting time being part of the solution.”

The 3base technology allows Genetic Signatures to offer high-throughput screening with broad target coverage, whereas most competitors offer one or the other. It converts the naturally occurring four-base genetic sequence of a pathogen (adenine, cytosine, guanine and thymine, or A, C, G and T) to a three-base sequence (A,G and T) using its sodium bisulfite method of conversion. The sodium bisulfite reacts with cytosine and is converted to thymine.

This process decreases heterogeneity, or complexity, by reducing the differences between subtypes, Melki said.

"For example, if we design a test for influenza – Avian flu, swine flu, pandemic flu are all influenza A strains – but they all differ at the genetic level that affects their pathogenicity. They are very similar, but they have this small amount of variation, and it's the challenge of every molecular test in the world to pick up all the subtypes. We make all of the influenzas more similar to each other at the genetic level; therefore, we can build a test that is better able to detect all of the subtypes," Melki said.

The test is geared toward labs conducting medium- to high-throughput testing, and “it’s an open platform that works on equipment already in the lab, but we also have instrumentation that we’ve worked on for five years that gives labs a tremendous amount of throughput,” the CEO said. 

Kits already have been shipped to Europe, and the CE mark will clear the way for supply contracts with new, larger European customers. Negotiations are underway with potential customers in Germany, the U.K. and Spain.

The system is in use as the company is currently supplying IVDs under regulatory exemptions to the U.K., Germany, Spain and Australia.

Applications have been submitted in Australia and the U.K., and the company is gearing up to submit an application for emergency use authorization (EUA) to the FDA.

The data generated to support the submissions as required by the European In Vitro Diagnostic Directive and Australia’s Medical Devices Regulation will allow the product to be marketed as an IVD in Australia and Europe. The data submitted for European approval also supports the FDA EUA application.

Genetic Signatures has several products marketed in Australia that target gastrointestinal and respiratory diseases, as well as antibiotic-resistant superbugs.

The company raised funds in November 2019 to extend its global footprint by expanding the sales team in the U.S. and Europe to market its suite of multiplexed molecular diagnostic tests that screen for infectious diseases.

The technology allows the company to screen a large number of targets across bacterial, protozoan and viral pathogens, Melki said.

In the U.S., the company markets its analyte specific reagents (ASRs) to labs for use in lab-developed tests, and it planned to submit a 510(k) to the FDA in mid-2020 for its enteric protozoa kit. The ASRs represent an early revenue opportunity.

Genetic Signatures' target markets – the U.S., Western Europe and Australia – were worth about $6.4 billion in 2018 and are expected to grow to $10 billion by 2026, according to Bell Potter analysts.