Histoindex’s Stain-Free Digital Pathology System Receives HSA Approval for Liver Diagnosis
Designed to aid pathologists in the clinical diagnosis of liver fibrosis and other chronic liver diseases, the stain-free Laennec® digital pathology imaging system by MedTech innovator Histoindex Pte. Ltd. has achieved its first regulated in vitro diagnostics (IVD) product status with the issuance of a Health Sciences Authority (HSA) Class A licence. This is a world’s first achievement for a stain-free digital pathology innovation to be approved for use in a clinical diagnosis setting. Pathologists in Singapore can now rely on Laennec® to efficiently and accurately carry out their diagnostic procedures for liver fibrosis, particularly Nonalcoholic steatohepatitis (NASH), which is a severe form of Nonalcoholic fatty liver disease (NAFLD).
Changing the Way Pathologists Interpret Liver Fibrosis
Clinicians today have shown a strong interest in the use of digital pathology as it simplifies diagnosis by enabling the assessment of tissue slides automatically, instead of examining a slide under the microscope manually. Looking at the current histopathological procedure, tissue samples — obtained from a liver biopsy — are stained by a pathologist to manually visualise and stratify the disease. Such an approach is often time-consuming and may produce inconsistent results between different pathologists. With a digital pathology system, pathologists can also track the disease progression and treatment efficacy, all of which are crucial in ensuring better patient outcomes.
Laennec® uses a novel Second Harmonics Generation (SHG) and Two-Photon Excitation (TPE) technology to scan tissues and generate digital images that highlight diseased cells and collagen fibres. Furthermore, the tissues need not be stained, therefore preserving tissue integrity. Combined with software algorithms, the system is able to isolate, quantify and characterise features of collagen fibres within the tissue to objectively and accurately stage liver fibrosis.
This technology was highlighted in a number of clinical studies conducted worldwide, notably in one which saw the participation of Professor Stephen Harrison, Medical Director of Pinnacle Clinical Research and Chairman of HistoIndex’s Scientific Advisory Board. This study, presented at The Asian Pacific Association for the Study of the Liver conference in 2016, involved biopsy samples from 101 patients with NAFLD and NASH. It revealed that the quantitative assessment using SHG collagen features was more robust for evaluating fibrosis in fatty liver, when compared with the traditional stained image semi-quantitative analysis. Prof Harrison explains, “This data supports the concept that quantitative assessment of liver collagen content is not only possible but likely superior to the methods currently being utilized in clinical practice. This novel tool has the potential to revolutionize the way we assess liver disease severity by biopsy.
Breaking Grounds in Digital Pathology
HistoIndex’s regulatory milestone was achieved as a result of a collaboration between Singapore’s Diagnostics Development (DxD) Hub, a national initiative led by the Agency for Science, Technology and Research (A*STAR), through its commercialization arm Exploit Technologies Pte. Ltd. (ETPL), and the Singapore General Hospital (SGH).
“This achievement for Laennec could not have come at a better time, where liver experts are tackling NASH and its escalating rise in Singaporeand around the world,” says Dr Gideon Ho, Chief Executive Officer, HistoIndex. “Clinicians can now rely on Laennec to accurately diagnose and stage NASH as well as other chronic liver diseases, and predict clinical outcomes. This is in alignment with our vision to provide a consistent and reliable approach that augments diagnosis so as to place patients on the road to a speedy and complete recovery.”
HistoIndex is currently in discussion with public hospitals and laboratories in Singapore to implement the Laennec® imaging system as part of their pathology workflow. Also, as part of HistoIndex’s globalisation strategy, the company is on track for the China Food and Drug Administration (CFDA) regulatory approval by Q3/Q4 2018 and has been exploring various partnership opportunities with hospitals in Chinathat will greatly benefit from having Laennec® in their pathology laboratory.
Source: Histoindex
