Why did we Invest - Tvaster Genkalp

Chronic liver disease (CLD) poses a significant health hazard due to its progressive nature, leading to severe complications, including liver failure and hepatocellular carcinoma (HCC). Chronic liver diseases accounted for approximately 3.17 % of all deaths in India, highlighting their significant impact on public health. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), cirrhosis, a late stage of CLD, is the 12th leading cause of death in the United States, with over 41,000 deaths attributed to chronic liver disease annually

The problem

Chronic liver diseases (CLD) are strongly linked to hepatocellular carcinoma (HCC) because they often lead to cirrhosis, a condition where liver tissue is replaced by scar tissue. This environment can promote malignant transformation, with up to 5-30% of cirrhosis patients developing HCC over five years. Whether due to hepatitis B or C infection, fatty liver disease, or other underlying conditions, the journey from chronic liver disease to HCC can be swift and treacherous.

In 2020, there were approximately 900,000 cases and 800,000 deaths from hepatocellular carcinoma (HCC) globally. Early detection of HCC becomes the key in improving patient outcomes and increasing survival rates and facilitating curative treatments. 

The product

Tvaster Genkalp is a chennai based startup co-founded by Dr. Srikar Raman and Ms Sreedurgaralaxmi in 2021 addressing a significant problem in the diagnosis of Hepatocellular Carcinoma (HCC), which is the most common form of primary liver cancer. The current standard for HCC detection, alpha-fetoprotein (AFP), has limited sensitivity, typically around 50%, leading to late diagnosis and poor patient outcomes. This limitation is particularly concerning because early detection is crucial for improving survival rates. Patients with Chronic Liver Disease (CLD), especially those with cirrhosis, are at high risk of developing HCC, but traditional methods often fail to identify the disease early enough for effective treatment.

To make HCC testing faster, non-invasive and more accurate, Tvaster has developed Episcreen Liver™, is a liquid biopsy test that targets methylation patterns in cell-free DNA, offering a more accurate and non-invasive diagnostic tool. By focusing on epigenetic markers, Episcreen Liver achieves a sensitivity of 90% and specificity of 89%, significantly outperforming AFP. This approach addresses the genetic heterogeneity of HCC, providing a robust alternative for early detection and improving patient outcomes by enabling timely interventions. 

Validated with clinical studies

Clinical studies for Episcreen Liver involved 600+ participants. The test achieved a sensitivity of 90% and specificity of 89% for detecting Hepatocellular Carcinoma (HCC). A 90% sensitivity rate indicates that a significant portion of individuals who underwent the Episcreen Liver test were successfully identified as potentially harboring hepatocellular carcinoma (HCC), compared to traditional testing with AFP.

Episcreen Liver targets methylation patterns, addressing HCC's genetic heterogeneity and offering a robust alternative to mutation-based diagnostics. Unlike AFP, hypermethylation signals are observed, in majority of the cases, only when an active tumor exists. It is well known that AFP remains negative for almost 50% of HCC patients.

Episcreen Liver also performed well across all stages, with detection rates of 86% for early stages and 93% for late stages. These results highlight Episcreen Liver's potential as a reliable tool for HCC screening and surveillance.

Treatment response and Recurrence Monitoring 

The application of Episcreen Liver goes beyond screening and surveillance and can be used as a tool for monitoring treatment efficacy and as a tool for monitoring down-staging of HCC. In their pilot clinical study, Hypermethylation patterns changed from "Signal Detected" to "Signal not detected" for 90% of the patients within 4 weeks.

Recurrence monitoring is a critical aspect of managing HCC patients, as HCC has a relatively high risk of recurrence even after successful treatment. The recurrence monitoring process involves regular follow-up and surveillance to detect any signs of tumor recurrence

Comprehensive Liver Cancer diagnostic platform.

Tvaster is also advancing its oncology diagnostics pipeline with Episcreen Bile, a novel test for Cholangiocarcinoma, an aggressive bile duct cancer with limited early detection options. They have also won the BIG-2023 grant funded by BIRAC under the diagnostics category for the development of their epigenetic-based blood test for Cholangiocarcinoma. The panel development aims to offer an effective and reliable diagnostic solution to identify Cholangio Carcinoma in Chronic Liver Disease patients.

Additionally, the company has developed Episcreen™ HBResist, the first-ever chemotherapy resistance test for pediatric hepatoblastoma, addressing a critical gap in childhood cancer treatment.

The Indian diagnostic market

The Indian diagnostic market is also seeing a growth phase right now and is projected to reach $25 billion by FY28, up from $13 billion in FY23 at a CAGR of 14%. The COVID-19 pandemic has reshaped the healthcare market, emphasizing home collection services and  the proliferation of molecular testing. There has been tremendous growth in the number of NABL accredited molecular testing labs from 40 in March CY20 to 2262 in August CY23

Ideaspring Capital is excited to partner with Dr. Srikar and Ms Sreedurgaralaxmi on this exciting journey that will enable early detection of liver cancer globally thereby improving the chances of survival as well as leading to a better quality of life for patients.