• Lumos granted approvals by the US FDA for the ViraDx test
  • Imugene receives positive feedback from FDA for CAR T cell therapy
  • Genetic Technology expands its geneType Multi-Risk Test in Australia


Lumos granted US FDA approval for ViraDx

Market darling Lumos Diagnostics (ASX:LDX) gained 5% this morning after providing an update on its combined COVID-19/Flu A/Flu B rapid POC test kit, the ViraDx test.

Lumos says the US FDA has granted ViraDx an Emergency Use Authorisation (EUA) and a CLIA Waiver (Clinical Laboratory Improvement Amendments).

What this means is ViraDx can now be used by US healthcare professionals including healthcare sites operating under the CLIA Certificate.

Lumos says the next step is to offer the test to healthcare providers in the US through its recently established sales channel.

ViraDx is a rapid POC test that simultaneously tests for acute respiratory infections caused by the COVID-19, influenza A, and influenza B viruses. The test uses nasal or nasopharyngeal swab samples and provides a result within 15 minutes. The qualitative results are visually read, easy to interpret, and require no additional instruments.

“This is an important addition to the suite of products that we will offer healthcare professionals through our recently established US sales channel,” said Lumos CEO, Doug Ward.

“It is also a credit to the expertise and capabilities of Lumos’ clinical and regulatory teams that they have managed to secure two US regulatory registrations for Lumos’ point-of-care products within the last three months.”


Imugene receives positive feedback from FDA

Imugene (ASX:IMU) says it has received positive feedback from FDA on an improved manufacturing process for the azer-cel, an anallogeneic (off-the-shelf) CD19 CAR T cell therapy for auto CAR T relapsed patients with blood cancers.

The FDA ruled that the azer-cel manufacturing process can be used in the pivotal clinical trial, and potentially for manufacturing of the commercial product.

Azer-cel is currently being studied in an ongoing multi-centre Phase 1b clinical trial in patients with non-Hodgkin’s lymphoma (NHL), and acute lymphocytic leukemia.

Azer-cel has demonstrated clinically acceptable safety profile, including promising results in DLBCL (Diffuse Large B-cell Lymphoma) patients who relapsed following CAR T.

“Azer-cel has the potential to be the first CD19 directed allogeneic cell therapy, and having the FDA support on the manufacturing process that can be used for the pivotal trial is an extremely important milestone for Imugene,” says CEO, Leslie Chong.


GTG expands geneType Multi-Risk Test in Australia

Genetic Technologies (ASX:GTG) says that its expanded geneType Multi-Risk Test is now available to order in Australia.

The three new diseases – pancreatic cancer, melanoma, and atrial fibrillation – were approved for sale in Australia by the National Association of Testing Authority (NATA).

The geneType Multi-Risk Test now performs a total of nine individual serious disease risk assessments, all from the one simple saliva sample.

Separately, GTG announced that a Medical Research Future Fund (MRFF) grant has been awarded to a group of renowned national and international research and charity organisations.

The grant will provide funding for the CASSOWARY Trial – a trial aimed to investigate how funding for genomics-based cancer screening can be utilised in the future.

The MRFF has named GTG as sole Industry Partner for this study, meaning that GTG will receive funding to cover the supply of test kits and the analysis of the sample returned.


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