Singapore-based HistoIndex has launched a new AI-based laboratory developed test (LDT) in the US for measuring fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Ideating on HistoIndex’s previous LDT, FibroSIGHT Plus adds automated quantitative analysis of fibrosis, allowing for more “consistent and precise” characterisation at diagnosis and tracking of fibrosis in MASH patients, according to the company.
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Built on HistoIndex’s proprietary qFibrosis algorithm, the new LDT automatically quantifies fibrosis-related changes based on second-harmonic generation (SHG) imaging of MASH liver biopsies and quantifies the results into a single fibrosis stage value.
Fibrosis, or scarring, in MASH patients is viewed as a key determinant of long-term health outcomes for individuals with the condition.
According to HistoIndex, the LDT’s ability to qualify fibrosis on a continuous scale, rather than in categories, allows for more detailed insight into the disease’s severity, thereby allowing clinicians to more accurately characterise MASH patients and monitor disease changes over time.
Commenting via a HistoIndex press release, Dr Naim Alkhouri, chief academic officer at Summit Clinical Research and director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio, said: “The ability to detect incremental changes in fibrosis with this level of precision is exactly what we need to guide earlier and more targeted interventions in MASH.”
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By GlobalDataThe MASH market surge
Characterised by the buildup of fat in the liver, MASH results in inflammation and potential organ damage. According to GlobalData estimates, there are approximately 4.9 million diagnosed cases of MASH among individuals 18 years and older in the US.
Across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan), GlobalData analysis projects that the MASH market will hit a valuation of around $25.7bn by 2032, thereby representing huge market potential for entrants in the space.
The first pharma treatment for the disease was approved in the US last year when Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) won approval from the US Food and Drug Administration (FDA) in March 2024.
LDTs in the US market
The FDA’s ‘Final Rule’, asserting that LDTs were medical devices and would therefore be regulated under the same standards, was struck down in a Texas court in April.
However, despite setting aside the heightened regulatory scrutiny LDT manufacturers would have faced in the US and mitigating the attendant industry concerns, some observers have pointed out that the commutation of the FDA’s rule in April does not solve the underlying problems with oversight of LDTs.
Harvard Medical School’s Dr Kushal Kadakia said: “The outcome [Texas court decision] does not close the door to regulatory reforms but rather resets the table for debate as to how regulatory frameworks can be adapted over time to keep pace with technological advances.”
While the FDA’s role in regulating LDTs has been restricted through the court decision, Kadakia added that it “simply preserved the status quo, as the FDA’s preexisting posture of enforcement discretion meant that LDTs were frequently being marketed without clinical or regulatory oversight”.
