The add-on to biopsy

trublood is a minimally invasive, diagnostic test that can clearly identify cancer in symptomatic patients. trublood provides diagnostic information similar to that of a tissue biopsy when it is inconclusive or not possible. Based on the test result, therapy can be aligned.

About trublood

trublood was developed by Datar Cancer Genetics based on the results of several clinical studies and validated on more than 40,000 samples. These included samples from asymptomatic subjects undergoing screening tests such as mammograms, colonoscopies, PAP smears, serum CA markers and other clinical examinations, as well as more than 17,000 samples from patients with various cancers and patients with benign diseases.

trublood basics

  • Tumours release thousands of cells into the circulation, where circulating tumour cells (CTCs) survive for about 1 - 2.5 hours.
  • In order to detach from the primary tumour and disseminate into the blood, cells must undergo a cellular process known as Epithelial Mesenchymal Transition (EMT).
  • EMT enhances migratory capabilities of tumour cells, which allows cells to penetrate into the vasculature and circulate as single or clusters of circulating tumour cells.
  • CTCs extravasate having undergone the reverse process known as Mesenchymal to Epithelial Transition (MET) and are able to colonise at distant organs.
  • CTCs are defined as EpCAM (+), PanCK (+), CD45 (-) cells. Circulating tumour associated cells (C-TACs) are EpCAM (+), PanCK (+), CD45 (+/-) cells of tumourigenic origin in peripheral blood.
  • Non-tumourigenic cells in peripheral blood have functional apoptotic mechanism, but CTCs and C-TACs are resistant to apoptosis.
  • An epigenetically active stabilising process can eliminate normal cells and confer survival privilege on apoptosis-resistant CTCs and C-TACs.
  • Sufficient C-TACs can be enriched and harvested for immunocytochemistry (ICC) profiling with markers used in immunohisto-chemistry (IHC) which aid in determination of histopathological subtypes of tumour tissue.
  • To increase the sensitivity of the method, circulating free DNA (cfDNA) is examined at the same time. In very rare cases, no CTCs but cfDNA can be found, which leads to a positive result. However, cfDNA alone cannot provide any indication regarding the origin of the tumor disease.

trublood is particulary recommended for ...

<p>... symptomatic individuals in whom a tissue biopsy is difficult to perform.</p>

... symptomatic individuals in whom a tissue biopsy is difficult to perform.

<p>... patients in whom standard procedures (imaging, biopsy) have failed to provide a result or are not consistent with clinical observations.</p>

... patients in whom standard procedures (imaging, biopsy) have failed to provide a result or are not consistent with clinical observations.

 

trublood can complement, or if necessary, replace invasive biopsies.

Sample collection

,

3 tubes containing 30 ml whole blood

Blood draw: 2 EDTA tubes (purple colour cap) - 2 x 10 ml and 1 STRECK tube - 1 x 10 ml

Note:
Sequence of draw should not be altered. Blood should be drawn only and only as per above method. Blood draw should be performed only by qualified phlebotomist under medical supervision. Ship at +2°C to +6°C in the container provided by DCG.

Precautions:

  • The patient should remain fasting for the last 6 hours before the blood sample is taken. The intake of liquids is permitted.
  • Patient has not received blood transfusion / PET-CT / CT scan at least 5 days prior to collection of sample.
  • A detailed report on the patient's current situation.

FAQ

Which clinical relevance does trublood have?

To date, 6 clinical studies with over 40,000 individuals have been published regarding trublood and early cancer detection.

How is the analysis performed and which analytes are included?

Circulating tumour cells (CTCs / C-ETACs) and nucleic acids (ctDNA) are isolated and comprehensively analysed.

Trublood is available for the following organs:

Breast, CNS, colorectum, lung, pancreatobiliary and prostate.

Is trublood applicable in the following cases?

Is trublood able to distinguish between adeno- and squamous cell carcinoma? YES.

Can trublood determine the grade of tumour? NO.

Can trublood be used for haematological malignancies? NO.

Can CTCs be found in the blood of in situ carcinomas? In the case of in situ carcinoma, up to 3 million CTCs can be found in the blood.

What are the most important facts regarding the sample collection?
  • 30 ml peripheral blood as per protocol
  • 6 hours fasting before test
  • Turn-Around-Time: 10 working days (Monday - Friday) from receipt of the sample