• Rhythm Bio says biomarker findings warrant the case for new investment in R&D
  • Dental focused SDI says product registration globally is becoming more difficult to achieve

 

Rhythm Bio says new R&D investment is warranted after this finding

Rhythm Biosciences (ASX:RHY) has provided an update on its cancer diagnostics technology platform in lung cancer.

As previously announced in December last year, Rhythm, together with the Baker Institute, have identified a 5-biomarker combination that exhibits an effective correlation with various stages of lung cancer.

This combination was identified from a preliminary assessment of 17 biomarkers, which was performed by the Baker Institute in a “research use only” feasibility immunoassay study.

The study evaluated these 17 blood-based biomarkers from 70 lung cancer patients, and 71 healthy volunteers.

Out of these 17 biomarkers, preliminary results identified an important 5-biomarker combination that can distinguish between patients with lung cancer, and those that are healthy, with a >85% sensitivity and >90% specificity.

Rhythm now says these encouraging results warrant confirmation in a larger population, and justify the continuation and advancement of the project.

These results would also support the case for investment in a new R&D program to develop, validate, clinically evaluate the performance of the biomarkers, and translate these results into a commercially scalable blood test to detect lung cancer early.

Lung cancer remains the leading cause of cancer-related deaths worldwide, primarily because most people only seek treatment when the stage is too advanced to offer any reasonable chance of cure.

The Australian Institute of Health and Welfare estimated that in 2022, 14,529 Australians were diagnosed with lung cancer, and more than 8,606 died from the disease.

Overall, the five-year survival rate for lung cancer is low, at about 22%, and there is a clear need to improve the diagnostic tools for screening in detecting early-stage lung cancer.

 

SDI says getting approval is getting harder

The dental device focused company, SDI (ASX:SDI), fell -4% this morning following management’s presentation at the company’s AGM.

Chairman Jeffery Cheetham explained that in FY23, the company made solid progress focusing on successfully growing its key product categories.

“We achieved record sales of $107.9 million, a fantastic result and I would like to take this opportunity to acknowledge and thank all SDI’s teams for their dedication,” said Cheetham.

Cheetham said he was confident that SDI will increase market share as we come out of Covid.

“The continued focus on aesthetic and whitening products is a solid strategy for the future direction of our portfolio.

“We continue to benefit from two of the main amalgam competitors leaving the category, with dentists switching to our brand,” he said.

Cheetham acknowledged however that the new European Union Medical Device Regulation (MDR) has been a major focus for the SDI team over the last 12 months.

“Globally, product registration is becoming more difficult to achieve, adding a significant barrier to entry in our markets.”

Looking ahead to 2024, Cheetham said the company will be focused on a few goals, including the build of a new warehouse, and ensuring the European MDR registration is achieved.

“These are great goals for the year to ensure the company is well placed to achieve increased market share for the future,” he said.

 

Rhythm and SDI share prices today:

 

 

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