Genetic Signatures receives FDA approval

Genetic Signatures (ASX: GSS), a company known for its molecular diagnostic solutions for infectious diseases, has just received clearance from the US FDA for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow.

This is a significant announcement in the world of clinical diagnostics, especially for expanded testing for gastrointestinal (GI) parasites.

The approval means that healthcare professionals now have a powerful new tool to accurately and quickly diagnose these kinds of infections.

Every year, more than 3.5 billion people worldwide get infected with GI parasites, causing over 200,000 deaths and a lot of health and economic problems.

In the US alone, there are about 65 million cases of GI infections each year, but only 15% of them are actually reported to doctors.

These parasites can come from contaminated water, food, or surfaces, and even from international travel. Sometimes people don’t even have symptoms, but they can still spread the infection.

Currently, diagnosing these infections in the US relies a lot on using microscopes, which takes a long time, is complicated, and needs highly trained staff.

Genetic Signatures’ EasyScreen Gastrointestinal Parasite Detection Kit is a game-changer as it offers a comprehensive solution for detecting the parasites.

It uses GSS’ proprietary technology called 3base to identify eight of the most common and important GI parasites all at once, from just one sample.

Neil Gunn, interim CEO of Genetic Signatures, said:

“Our unique 3base technology offers significant differentiation and advantages for molecular testing of the most challenging samples and gastrointestinal parasites that impact over 60 million patients a year in the US.”

The process is also automated, so it’s much faster and easier than using a microscope.

This means doctors can get results quickly and make sure patients get the right treatment as soon as possible, which also helps save money on healthcare.

“Securing FDA clearance marks a major milestone for Genetic Signatures,”  Gunn said.

“We are excited to offer patients and customers a new solution to a major health care issue in the US.”


New CEO and $30m cap raise

On the back of this announcement, GSS has also just appointed a new permanent CEO, Allison Rossiter.

Rossiter has a lot of experience in the diagnostics industry, especially with Roche Diagnostics, where she’s been working since 2003 in different parts of the world. Since 2019, Allison has been the managing director at Roche Diagnostics, Australia.

In addition, GSS has also announced an approximately $30 million cap raise.

Around $6m of that is earmarked for placements to institutional investors, and $24m will be for eligible GSS shareholders – at an issue price of $0.75 a share.

All eligible directors of GSS intend to participate in this offering, GSS said.


Lumos receives US$5m under IP deal

Lumos Diagnostics (ASX:LDX) has announced the receipt of a second payment of US$5 million from Hologic, Inc. (NASDAQ: HOLX) under the Intellectual Property (IP) Agreement disclosed in January.

This recent payment brings the total received under the IP Agreement to US$10 million.

Under the terms of that IP Agreement, Hologic has been granted an exclusive licence in the field of fetal fibronectin (fFN) to Lumos’ proprietary reader and point-of-care technologies.

These technologies are set to be integrated into the next-generation Hologic fFN diagnostic product, currently in development.

Lumos has successfully completed Phase 1 of the associated Development Agreement, valued at US$0.4 million, which primarily focused on Product Definition and Planning.

This phase is part of a three-phase program with a total value of US$4.7 million. Payment for Phase 1 is anticipated by June 30, 2024.

Lumos’ shares jumped +8% this morning.


Optiscan unveils new device

Optiscan Imaging (ASX: OIL), meanwhile, has unveiled its innovative new medical imaging device, InVue.

InVue was designed to revolutionise precision surgery by granting surgeons immediate access to real-time digital pathology.

Developed in collaboration with the industrial design firm Design + Industry, based in Sydney and Melbourne, InVue marks a significant advancement in the field of pathology.

It has bridged the gap between traditional laboratory-based approaches and the operating theatre, said Optiscan.

Unlike conventional methods that involve time-consuming procedures and delayed results, InVue enables surgeons with on-the-spot pathology insights, enabling informed decision-making and precise surgical interventions.

By facilitating quicker and more accurate diagnoses, the device aims to minimise the need for multiple diagnostic procedures and repeat surgeries – ultimately enhancing patient outcomes and reducing healthcare costs.

Optican’s share price surged by almost +30% this morning.