top of page

Episcreen Liver offers an unparalleled test performance 

Exceptional test performance obtained in clinical study. The performance of Episcreen Liver is supported by 1000+ clinical samples and over 500 participants.

Early Access Program - Liver Cancer Screening

Episcreen Liver, the first-of-its-kind liquid biopsy test, performs significantly better than the current blood-based biomarker test Alfafetoprotein (AFP) in detecting Hepatocellular Carcinoma and is made available in 2 centres

Young Doctor_edited.png

A prospective cohort study with HCC patients and Chronic Liver Disease patients with all etiology tested in real-world settings

Episcreen Liver test has been developed after rigouros validation. The test was carried out in 2 phases namely discovery phase and validation phase. In the discovery phase, the genes that are highly specific to HCC were selected and samples from patients (HCC and non-HCC/CLD) undergoing liver resection and transplant were analyzed to set biological reference levels.

In the validation phase, real world scenario was adopted and patients coming for follow-ups and screening were recruited for the clinical study. The test performance pertains to the real-world clinical scenario without any bias.

We collaborated with leading liver speciality and cancer institutes to study Episcreen Liver test

89%

Sensitivity

90%

Specificity

71%

PPV

97%

NPV

600+ patients in 1 year

Highly accurate HCC screening 

An 89% 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, which demonstrated only a 60% sensitivity rate.

Cancer signal was detected through hypermethylation in these subjects. Unlike AFP, hypermethylation signals are observed, in majority of the cases, only when active tumor exists. It is well known that AFP remains negative for almost 50% of HCC patients.

A visual representation of methylation patterns in 3D space

40% of patients who tested negative for AFP were identified using
Episcreen Liver 

image.png
image.png

Screening and Surveillance

Screening and Surveillance helps understand the patient’s status based on methylation profile. Confirmed HCC patients have significantly higher methylation levels compared to CLD patients

At a specificity of 90%
Episcreen Liver shows Sensitivity of

86%

93%

image.png
image_edited.png
image.png

EARLY STAGE BCLC 0/A

LATE STAGE BCLC C/D

EPISCREEN LIVER CAN DETECT HCC SIGNALS IN THE EARLY STAGES OF THE CANCER

Image by National Cancer Institute

Early detection of HCC improves the prognosis and survival 

Patients diagnosed with early stage diagnosis and appropriate treatment have a better prognosis, with a 5-year survival rate of more than 70%

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. For HCC patients undergoing treatment, to monitor response and recurrence, and where the Episcreen Liver test yields a negative result before intervention for, it's advised against using the test for recurrence monitoring or for treatment response.

 

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. 

bottom of page