Yes, it can most often differentiate between common subtypes such as adenocarcinoma vs squamous cell carcinoma.

Trublood® can distinguish common subtypes such as adenocarcinoma vs squamous cell carcinoma vs neuroendocrine tumors. However, classification into some rare subtypes of epithelial malignancies is currently not feasible with Trublood®.

Trublood focuses on detection of epithelial malignancy and its subtyping. It does not detect grade of the tumor.

Trublood® is ultrasensitive detection of circulating tumor associated cells followed by their immunocytochemistry (ICC) staining to identify specific subtype.

Circulating Tumor Cell (CTC) test involves only enumeration of CTCs. In Trublood® the initial isolation/harvesting of CTCs is done by specialized proprietary method which helps to isolate maximum number of CTCs followed by their in vitro expansion to amass enough CTCs for further testing. Following this, the CTCs are stained with specific ICC based antibodies to identify histopathological subtype.

Trublood® and CTC ‘enumeration’ are two different solutions with different purpose. Trublood® is for detection of carcinoma in a patient with specific symptoms or cancer associated signs (e.g. suspicious lesion on radiology). Trublood® does not provide CTC enumeration and hence is not intended as a baseline for future cancer monitoring of a trublood® positive patient.

Trublood® validation cohort did not include carcinoma in situ cases. However, literature records detection of CTCs in carcinoma in situ cases.

Trublood® validation cohort included both non-metastatic (early stage) and metastatic cancers and overall sensitivity was found to be 94.6%.

Trublood® utilizes theranostic ICC antibodies such as ER, PR, HER2, PD-L1 as requested or found relevant. Additional cell free DNA (cfDNA) and Fluorescence In Situ Hybridization (FISH) analysis can be availed to identify targetable alterations (Theranostic markers, cfDNA and FISH are available at extra cost and are optional).

Trublood® is not a cancer screening test. It is meant for detection of cancer in a suspected patient with either signs or symptoms suggestive of a particular organ involvement.

Trublood® has been validated for cancer patients suspected with a specific organ involvement e.g. female with complex ovarian cyst on USG of abdomen. The specificity and sensitivity of Trublood® pertains to such organ specific detection of cancer. It is currently not offered to patients without clinical suspicion of a particular organ involvement.

Peripheral venous blood is collected for Trublood® test. Even though the method of blood draw is similar to any routine pathology test, Trublood® requires sample to be collected, stored and transported as per specific instructions provided in Trublood® kit.

The sample is transported in temperature-controlled boxes.

Consultation with the treating physician to undertake further clinical investigations is advised.

Trublood® test has been validated and reports objective findings based on immunocytochemistry of circulating tumor cells. It is a very specific test with statistically insignificant chance of a false positive. However, decision for confirmation of presence of malignancy is to be taken by the treating physician, if so desired.

Trublood® has been validated in a prospective observational studies with 40,000 subjects which included more than 15,000 samples from cancer patients. Results of immunocytochemistry were compared with available histopathological cancer type in these patients. The trial details are as under:

1. CTRI Registration No. CTRI/2019/01/017219; and
2. CTRI Registration No. CTRI/2019/03/ 017918.

CTCs in clusters are detected in 89.8% of cancer patients, whereas CTCs present in circulation without clusters are found in additional 4.8% of the cases. So, the overall sensitivity of this test is 94.6%. The specificity of Trublood® is 97.0%. The dataset for Trublood® prospective observational study included more than 40,000 subjects including more than 15,000 cancer patients.

Organ wise sensitivity is as follows:

Yes. Clinicians are adopting Trublood® in people suspected with a particular organ cancer especially where invasive tissue biopsy may not be feasible, such as unwilling patients, inaccessible lesion or associated comorbidities.

Follow up Trublood® testing after a month and consultation with your treating physician to decide future course is advised.

Trublood® cannot be offered to individuals less than 18 years of age, as it has been validated in adults over 18 years of age.

Trublood® is a non-invasive alternative to tissue biopsy which informs about presence or absence of cancer and if cancer is present, its histopathological subtype. Additional testing for relevant theragnostic markers can also be availed in Trublood®. Thus, suspected patients can obtain this information without a tissue biopsy.

Trublood® cannot detect certain mesenchymal or haematolymphoid malignancies. Certain rare subtypes of carcinomas cannot be distinguished/detected with Trublood®.

Yes. Generally, after histopathological diagnosis of carcinoma, the tissue blocks are submitted for relevant cytogenetic testing such as FISH (e.g. HER2 in Breast cancer, ALK in NSCLC) or mutation testing (e.g. EGFR, KRAS in NSCLC) or IHC testing (e.g. ER/PR/Her2 in Breast cancer). Such theragnostic markers can be tested through Trublood® platform at additional cost.

Positive result of the Trublood® test is a decision support tool for the treating clinician and it is the discretion of each doctor to decide the sufficiency of evidence to accept diagnosis and for starting a particular regimen of treatment. Further, doctors take into consideration all the relevant information and test results for an individual patient and the weight to be given to each input will therefore depend upon the clinician’s judgment in each case.

No.