Histoindex's Stain-Free Digital Pathology System Receives HSA Approval for Liver Diagnosis
SINGAPORE, 11 JANUARY 2018 – Designed to aid pathologists in the clinical diagnosis of liver fibrosis and other chronic liver diseases, the stain-free Laennec® digital pathology imaging system (below) 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
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.
Seen here is a stain-free generated image of NASH liver tissue from the Laennec®, which uses an ultra-high resolution imaging technology that highlights fine collagen fibres. This cannot be observed with conventional staining techniques.
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 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 China that will greatly benefit from having Laennec in their pathology laboratory.