ASX Health Stocks: Resonance gets green light in US
Health & Biotech
Health & Biotech
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Medical imaging software Resonance Health (ASX:RHT) has received the green light in the US for its LiverSmart medical device, making it eligible for recognition by the US government agencies and private insurers.
Resonance received confirmation from an independent US CPT Code Certifier that performed the review, which concluded that the device is eligible for up to two new US (Category III) Current Procedural Terminology (“CPT”) codes.
CPT codes are a set of codes, descriptions and guidelines maintained by the AMA (American Medical Association) and recognised by US government agencies and private insurers.
The review recommends that CPT code 0648T applies when LiverSmart is performed without other documented diagnostic liver imaging, and CPT code 0649T applies when additional diagnostic liver imaging is performed in the same scanning session.
“The confirmation of applicability of two new CPT codes represents a major milestone in the pathway to more widespread reimbursement of LiverSmart in the United States,” says Resonance CEO Michael Wells.
“Ultimately, our goal is to achieve third party reimbursement of our services so the barrier of affordability for the patient is removed. CPT coding is a critical milestone toward that objective,” he said.
Telix Pharmaceuticals Limited (ASX: TLX) has been granted a review period extension from the Danish Medicines Agency (DKMA) for its investigational product Illuccix (TLX591-CDx).
Telix had requested this extension to provide it with sufficient time to respond to the remaining data requests made by Eurozone regulator, European Pharmacopeia.
The extension has been agreed and granted by the DKMA on behalf of 13 European countries reviewing the application.
Breast cancer screening company, BCAL Diagnostics (ASX:BDX), says that recent analysis leads to greater focus of the BCAL breast cancer test.
Over the past six months, samples from a fourth cohort of patients have been examined.
The independent tests showed that a considerably reduced number of markers, compared with previous information, can be used to distinguish between blood samples of breast cancer patients and normal control samples.
“This independent review confirms what we’ve long been confident of at BCAL, the ability to detect breast cancer using a lipid based blood test,” commented BCAL executive chair Jayne Shaw.
“The new developments solidify BCAL’s commercialisation pathway in the Australian, USA and European markets,” he said.