Molecular diagnostics company Genetic Signatures (ASX: GSS) has received CE-IVD registration, paving the way for the sale of its “EasyScreen” Respiratory Pathogen Detection Kit in Europe.
The detection kit can identify 14 common respiratory pathogens, including Influenza A & B, Rhinovirus and M. pneumoniae.
The kit allows for rapid detection of pathogens in up to 94 specimens per batch in approximately 4.5 hours with minimal hands-on time for laboratory technicians which allows for a rapid high-throughput workflow.
Rapid identification of viral respiratory infections can be critical when it comes to initiating antiviral treatment and limiting the spread of the infection.
The company is buoyed by the fact the detection kit has broad market appeal, meaning it can be adopted in most testing laboratories with existing equipment.
Dr John Melki, Genetic Signatures’ chief executive officer, said the registration of its respiratory kit was an important win for its European commercialisation efforts and comes ahead of the Northern Hemisphere winter flu season.
“Our regulatory and product development teams have a proven track record of taking product through the regulatory process with three product ranges achieving full CE-IVD registration in the last 18 months,” he said.
“Our expanding European team now has a suite of products to advance sales in 2019 and beyond.”
String of approvals
This past year has been full of big milestones for the New South Wales-based company.
The European approval marks the third EasyScreen product to receive the CE mark, having previously received approvals for its Enteric range, as well as its ESBL & CPO Antibiotic resistant superbug detection kit.
While the company is making headway on its products for the overseas market, Genetic has also been progressing market entry of the EasyScreen Respiratory Pathogen Detection Kit in Australia.
In August, the company announced it had secured a major new domestic customer with a large Australian pathology service provider for its respiratory pathogen detection kit.
At the time, the company flagged anticipated sales to reach 1,000 tests per day during peak flu season for the customer which would significantly boost its domestic business.
Therapeutic Goods Administration (TGA) registration is expected in coming months.
Genetic’s shares gained traction on the approval news. In late morning trade, the stock was up 9.6% at $0.885.