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A Breakthrough in screening and surveillance for Hepatocellular Carcinoma 

Tumorigenesis blood-based Epigenetic Markers Panel developed by Tvaster Genkalp is first of the kind in the world. The test allows you to significantly go beyond the current capabilities of blood based biomarkers enabling early and efficient detection of HCC signal.

Prevalence

Liver cancer, primarily HCC, is the 6th most common cancer worldwide. 1 Million new cases of liver cancer in 2020. 3rd leading cause of cancer death.

Concern

Liver cancer is expected to be 3rd most prevalent cancer by 2035. Chronic Liver Disease is in the top 10 for leading cause of deaths globally

Solution

HCC surveillance aims to detect the disease effectively to augment the likelihood of curative treatment. According to AASLD recommendations, CLD patients are at high risk for HCC should be screened.

A RELIABLE AND EASY LIVER CANCER SCREENING TEST

Higher performance than any other methods

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Screening with Episcreen Liver

a non-invasive, affordable and efficient method for detecting HCC

What is Episcreen     Liver ?

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Episcreen Liver is an advanced epigenetic-based molecular diagnostic solution for detection of HCC. Leveraging cutting-edge technology, Episcreen Liver identifies cancer signals through methylation patterns with a simple, single blood test.

Who is it for ?

Patients with chronic liver disease including cirrhotic liver face a heightened risk of developing HCC, a formidable challenge in the realm of liver health. 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. Episcreen Liver is suitable for such patients from the age group of 18 till 75.

Accurate and Reliable Results

In the clinical study of 500 patients, Episcreen Liver outperformed AFP and PIVKA with sensitivity of about 90% and specificity of 90% for all BCLC stages

Making it look simple. Episcreen Liver screens for HCC signals.

Episcreen Liver test checks multiple regions in cell free DNA (cfDNA) that have been reported to be hypermethylated in the case of HCC. Using in silico models and multiple testing, we have developed panel and process specifically tweaked for detecting HCC with high precision. We combine the methylation patterns obtained from Episcreen Liver test with a proprietary algorithm to obtain highly accurate results which is now validated in more than 600 patients. qSIMP-HCC is now called Episcreen Liver.

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One Test. Multiple Applications

Our test has been evaluated and clinically validated in more than 500 patients for HCC screening. We have gone beyond other tests and successfully established its application for other required but not-currently available solutions.

Recurrence Monitoring

Treatment Response Marker

Screening and Surveillance

Fast . Simple. Effective

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Test Prescription

Blood collection at the prescribing centre

Logistics

Episcreen Liver Analysis

Report shared with prescribing clinician

Important Safety Information

 

The Episcreen Liver screening test is recommended for use in adults with an elevated risk for Liver cancer, such as chronic liver disease patients. The Episcreen Liver test detects only Hepatocellular carcinoma and does not detect all liver cancers. This test should be used in addition to routine screening and surveillance liver cancer tests recommended by a healthcare provider. Episcreen Liver test is intended to detect HCC signals to corroborate the possible presence of the carcinoma. Use of Episcreen Liver test is recommended in individuals who are 18 years and older. The test performance decreases above the age of 75.

 

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Methylation Signal Detected or Low Risk” does not rule out HCC. A test result of “Methylation Signal Detected or High Risk” requires confirmatory diagnostic evaluation by medically established procedures (e.g. radiological imaging) to confirm cancer. In some cases (about 2%), the hypermethylation patterns exists in-between the 2 levels and is deemed “Indeterminate or Intermediate” necessitating closer follow-up.

 

The results, although qualitatively represented, also is quantitative and can be used as personalized methylation patterns.If HCC is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the presence of some other cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory and Test Information

This screening test is purely done for information purposes only. Tvaster Genkalp Pvt. Ltd. will not be accountable for any treatment or medication prescribed as a result of the test outcome. Although this test is highly accurate, there is still a possibility of false positive (~ 10%) and false negative (~ 10%) results. This is due to the technical limitations and/or the biological limitations, including but not limited to low cfDNA in the patient blood, interference from genomic DNA from lysed blood cells causing increased background noise or other rare molecular events. Patient samples with insufficient cfDNA cannot be analyzed. In which case, the patient can choose to give the blood sample again for re-extraction of cfDNA that might or might not lead to additional charges. Or else, the patient can choose to not have the test done. Tvaster Genkalp Pvt. Ltd. will not be accountable for any consequences as a result of treatment regimen decisions of oncologists. The test results are not valid for medico-legal purposes. This test has not been approved by any regulatory bodies. This test is lab developed test (LDT) and validated under real world clinical scenario by Tvaster Genkalp Private Limited. The test performance pertains to the validation. The test is carried out by Tvaster Genkalp Pvt. Ltd. 

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