- Rhythm Biosciences (RHY) files ColoSTAT with the Australian TGA for listing on the Australian Register of Therapeutic Goods (ARTG)
- TGA approval is needed for Rhythm and its partners to market and sell ColoSTAT in the Australian market
- Rhythm expects the review to be completed in three to six months and in the interim will execute key technical, administrative and logistical activities
- ColoSTAT measures the presence and concentration of protein markers seen in colorectal cancer and determines whether the patient has it or not
- Rhythm shares are trading steady at $1.21
Rhythm Biosciences (RHY) has filed ColoSTAT with the Australian Therapeutic Goods Administration (TGA) for listing on the Australian Register of Therapeutic Goods (ARTG).
TGA approval is needed for Rhythm and its partners to market and sell ColoSTAT in the Australian market.
With the application filed, the TGA will assess Rhythm’s ARTG submission and key technical documents to provide final approval to enable the commercialisation of ColoSTAT.
Rhythm expects the review to be completed in three to six months and in the interim will execute key technical, administrative and logistical activities.
ColoSTAT is a biochemical test that measures the presence and concentration of multiple protein markers seen in colorectal cancer.
The patient is first recommended for a ColoSTAT test by their doctor, before they give a blood test and the results are analysed.
If it reveals the patient has colorectal cancer then they will go in for a colonoscopy as soon as possible.
“The team continues to diligently execute on our plans as we target ColoSTAT revenues in late CY22,” CEO and Managing Director Glenn Gilbert said.
“We are very close to being in a unique position to transform and revolutionise the colorectal diagnostic market with our lifesaving cancer detection technology.”
Rhythm was trading steady at $1.21 at 2:18 pm AEST.