• Genetic Signatures jumps on FDA 510(k) application
  • Allegra says FDA has questions related to its 510(k) application
  • Proteomics granted patent in Japan


Genetic Signatures jumps almost 20pc on FDA update

There were a couple of FDA-related updates on the ASX this morning.

First, molecular diagnostics biotech Genetic Signatures (ASX:GSS) announced the submission of a 510(k) application to the US FDA as it prepares for market launch.

GSS is seeking regulatory clearance to market its EasyScreen Gastrointestinal Parasite Detection Kit in the US.

Currently, the diagnosis of gastrointestinal (GI) protozoan infections in the US primarily relies on sample culture and microscopy, supported by antigen detection and pathogen-specific molecular tests.

Whilst this approach is well recognised, it is time-consuming as well as labour-intensive, and can take several days to provide a result.

Meanwhile clinical trial data shows that Genetic Signatures’ EasyScreen Gastrointestinal Parasite Detection Kit provides an effective, rapid molecular test that covers the eight most common and clinically relevant GI parasites. The costs associated with using this test in the US are expected to be covered, with reimbursement of US$262.99.

The EasyScreen kit is already available in Australia, Europe and Canada.

GSS CEO Dr John Melki says the US is the largest single market for molecular diagnostic tests and represents a significant opportunity for EasyScreen.

“With a greater range of GI parasite targets provided in this syndromic solution, and the unique advantages of our 3base technology to detect these parasites, it is the ideal product to launch into the US market,” he said.

The GSS share price was trading more than 19% higher in the morning session.


Allegra says FDA has more questions

Allegra Orthopaedics (ASX:AMT) says the US FDA has requested additional information to answer specific questions related to its 510(k) submission of the Sr–HT–Gahnite Spinal Cage device.

Specifically, the FDA has questions related to the chemical characterisation and toxicological risk assessment of the device, animal performance testing, as well as sterilisation, packaging, and shelf-life validations.

Allegra says this is an expected part of the review process, and the company is now gathering available data and expects to send a formal response to the FDA within the next 2-3 months.

AMT’s shares rose almost 2% this morning.


Proteomics gets patent in Japan

In other news, Proteomics (ASX:PIQ) says its subsidiary OxiDx has been granted a patent in Japan for its platform technology to measure oxidative stress.

The patent marks the first of a new family of patents for OxiDx’s next generation diagnostics technology, which will significantly expand its IP (intellectual property) coverage.

Oxidative stress is implicated in over 70 health conditions with levels often reflective of a person’s health and fitness.

Measuring oxidative stress has broad application across multiple markets including as a complementary diagnostic (CDx) test for assessing treatment efficacy, and precision medicine by enabling personalised dosing in clinical trials.

It can also be used as an athletic monitoring tool for competition preparedness, reducing injuries in the professional sports and horse racing industries.

OxiDx’s platform measures systemic oxidative stress in a fingerpick blood sample by using a sensitive ratio-metric method to detect protein biomarkers in the blood. Samples can be collected in the home, clinic or even on the field.

“This patent helps ensure OxiDx’s technology is secured for many years to come, as we look forward to expanding into multiple markets and revolutionising the way oxidative stress is monitored and managed,” says executive chair of OxiDx, Ian Brown.


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