INOVIQ study validates the use of SubB2M as an aid in diagnosing malignant melanoma
Data from 144 tissue samples in the feasibility study demonstrated that SubB2M immunohistochemistry detected melanoma with 91% sensitivity and discriminated between malignant melanoma and benign skin lesions.
SubB2M-based immunohistochemistry applications represent a new product opportunity for SubB2M in the $1.9b immunohistochemistry market.
INOVIQ Ltd (ASX:IIQ) has successfully completed a feasibility study to evaluate the use of SubB2M as an immunohistochemistry (tissue-based test) reagent to aid in discriminating between benign skin lesions, malignant and metastatic melanoma.
SubB2M is an engineered protein that specifically detects the pan-cancer biomarker Neu5Gc that is found at elevated levels in multiple human cancers.
In a study of 144 tissue samples (13 normal, 17 benign, 92 malignant and 22 metastatic), SubB2M staining scores were significantly greater in malignant and metastatic samples when compared to benign skin lesions (p < 0.003 and p < 0.03, respectively).
Notably, cells staining positive for SubB2M approached 100% in malignant and metastatic tissues.
INOVIQ is developing SubB2M-based tests for multiple uses including monitoring of breast and ovarian cancers, and for a general health panel.
“Role as a pan-cancer biomarker”
INOVIQ CSO Dr Gregory Rice said: “The results obtained in this feasibility study support further optimization and validation of SubB2M as an IHC reagent, particularly as an aid in the diagnosis of malignant melanoma.
“Importantly, the detection of Neu5Gc in these cancer tissues is consistent with its role as a pan-cancer biomarker and further supports the development of INOVIQ’s SubB2M-based blood tests for breast and ovarian cancers.”
Findings support INOVIQ’s SubB2M diagnostics program
The cell staining was independently scored by Dr Ian Katz, senior pathologist at Southern Sun Pathology and senior lecturer at the School of Clinical Medicine, University of Queensland.
INOVIQ’s research-stage SubB2M immunohistochemistry (IHC) test has a sensitivity of 91% detection of malignant and metastatic melanoma tissue samples.
The IHC program confirmed the presence of Neu5Gc (the binding target of SubB2M) in multiple tissue sections including breast, prostate, cervical, ovarian, colorectal and skin.
These findings support INOVIQ’s SubB2M diagnostics program developing blood tests for monitoring of breast, ovarian and other cancers.
Commercialisation of liquid biopsy pipeline
INOVIQ CEO Dr Leearne Hinch said: “INOVIQ remains focused on the development and commercialisation of its liquid biopsy pipeline of exosome and SubB2M-based blood tests for cancer and other diseases.
“Having successfully completed this SubB2M IHC feasibility study, the company intends to seek interest from diagnostic companies and pathology laboratories to sublicense SubB2M for the development of IHC tissue-based tests.”
Significant market opportunity
The global immunohistochemistry market was valued at US$1.89 billion in 2021 and is expected to grow at a CAGR of 8.4% from 2022 to 2030.
Hospitals and diagnostic laboratories dominated the market and accounted for the largest share of more than 70.5% of revenue.
North America was the largest geographic segment accounting for 38.5% share.
The skin cancer diagnostics market size is expected to be worth US$5.8b by 2028, with the melanoma segment representing US$2b.2 In 2020, an estimated 324,635 people were diagnosed with melanoma globally and an estimated 57,043 people worldwide died from melanoma in the same year.