FAQ

DATAR tests

General Questions about CTCs

Q1. What are CTCs?

CTCs, or circulating tumor cells, are cancer cells that have shed from a solid tumor and entered the bloodstream. They have the ability to travel to different parts of the body and establish new metastatic tumors. The detection and analysis of CTCs have become feasible only in recent decades due to advancements in technology.


Q2. Is the mere presence of CTCs an indication of aggressive cancer?

Based on the study “Circulating tumour cells for early detection of clinically relevant cancer” by Rachel Lawrence et al., published in Nature Reviews Clinical Oncology, the presence of CTCs in a blood sample is significantly associated with aggressive tumors rather than merely indicating the presence of any tumor. Key points from the study include:

  • Early Metastasis: CTCs can indicate early metastasis, which is common in aggressive cancers.
  • Prognostic Value: CTC presence is linked to poor prognosis in various cancers, including prostate, breast, colorectal, bladder, head and neck, and pancreatic cancers.
  • Minimally Invasive Monitoring: CTCs offer a non-invasive way to monitor cancer progression and metastasis.
  • Distinguishing Aggressive from Indolent Cancers: CTC detection helps identify aggressive cancers that need immediate treatment, avoiding overdiagnosis of indolent tumors.
  • Technological Advances: Improved CTC detection technologies enhance early identification of aggressive cancers.

In summary, CTC presence suggests aggressive cancer with a high potential for early metastasis.


Q3. Will a positive result for CTC presence indicate aggressive cancer?

CTCs detected in patients with early-stage cancers might indicate aggressive disease due to their association with metastasis. This helps expedite diagnosis and treatment for aggressive cancers while avoiding overdiagnosis of slow-growing tumors.


Q4. Why is early detection important in cancer prognosis?

Early detection of cancer significantly improves prognosis as it allows for a broader range of treatment options before the disease advances. Detecting cancer at an advanced stage typically results in poor outcomes. Early detection, including through CTC analysis, can identify cancers that are not yet clinically evident.


Q5. What is the average size at which an imaging technique can detect cancer?

Advanced imaging technologies, such as multi-parametric MRI and PET–CT, can only detect primary tumors and metastases that are well established, typically consisting of over 109 cells.


Q6. Where do the CTCs come from?

CTCs can originate from both primary and metastatic tumor sites, providing a comprehensive representation of the tumor cell population compared to tissue biopsies.


Q7. Is there a timeline when I can expect a tumor to progress if a test reveals CTCs?

The presence of CTCs can indicate early metastatic spread, which may precede clinical cancer diagnosis by months or years. For example, in lung cancer, nodules were detected 1 to 4 years after CTC detection.


Q8. Do I have an increased risk of metastasis if I have CTCs?

Yes, the presence of CTCs indicates a higher risk of metastasis, especially if they successfully extravasate and establish metastatic tumors. However, early-stage cancer patients with detected CTCs may still receive curative treatments if there are no signs of overt metastases.


Q9. Will a tumor as small as 5 mm release CTCs?

Yes, even tumors as small as 5 mm in diameter can metastasize to multiple sites before detection. This early dissemination is evidenced by the detection of disseminated tumor cells (DTCs) in various early-stage cancers.


Q10. How many years can CTCs be detected in blood before a clinical diagnosis?

CTCs can be detected in the blood years before a clinical cancer diagnosis. For instance, lung nodules were identified 1 to 4 years after CTC detection in patients under surveillance.


Q11. Are there solutions to treat micrometastasis?

Yes, treatments targeting micrometastases include immune-checkpoint inhibitors and senolytic drugs that eliminate dormant cancer cells under cell cycle arrest, potentially eradicating micrometastases.


Q12. What is the purpose of DATAR’s various CTC tests?

DATAR’s CTC tests, including Exacta, CellDx, CancerTrack, TruBlood, TruCheck, and Chemo-Scale, are designed to detect, monitor, and analyze circulating tumor cells in the blood. These tests provide valuable information for early cancer detection, treatment planning, and monitoring the effectiveness of therapies.


Q13. How do CTC tests compare to traditional biopsy methods?

CTC tests are less invasive than traditional tissue biopsies. They involve a simple blood draw and can provide real-time information about the tumor’s molecular profile and its response to treatment. This allows for ongoing monitoring without the need for repeated invasive procedures.


Q14. What are the benefits of using CTC tests in cancer management?

CTC tests offer several benefits, including:

  • Early detection of aggressive cancers
  • Non-invasive monitoring of tumor progression and treatment response
  • Identification of potential drug resistance
  • Personalized treatment planning based on the molecular profile of the tumor
  • Reduction in the need for invasive biopsy procedures

Q15. How accurate are CTC tests in detecting cancer?

CTC tests are highly sensitive and can detect even a small number of circulating tumor cells in the blood. While they are not a replacement for all traditional diagnostic methods, they provide complementary information that can enhance the accuracy of cancer detection and monitoring.


Q16. Can CTC tests be used for all types of cancer?

CTC tests are applicable to a wide range of solid tumors, including breast, prostate, colorectal, lung, pancreatic, and bladder cancers. However, their use may vary depending on the specific type and stage of cancer.


Q17. Are there any risks associated with CTC tests?

CTC tests are generally safe and involve minimal risk, as they require only a blood sample. The primary risk is the potential for psychological impact, as learning about the presence of CTCs may cause anxiety or stress for some patients.


Q18. How do I prepare for a CTC test?

Preparation for a CTC test is usually straightforward. Patients may be advised to fast for a certain period before the blood draw. Specific instructions will be provided by the healthcare provider based on the type of test being performed.


Q19. How long does it take to receive results from a CTC test?

The turnaround time for CTC test results varies depending on the specific test. Generally, results are available within 8 to 10 working days from the receipt of the blood sample at the laboratory.


Q20. How are CTC test results used in treatment planning?

CTC test results provide detailed information about the molecular characteristics of the tumor. Oncologists use this information to tailor treatment plans to the individual patient’s needs, selecting therapies that are most likely to be effective based on the tumor’s profile.


Q21. Can CTC tests be used to monitor treatment effectiveness over time?

Yes, CTC tests are valuable for monitoring treatment effectiveness. Regular testing can detect changes in the number and characteristics of circulating tumor cells, helping oncologists assess how well a treatment is working and make adjustments as needed.


Q22. What advancements are being made in CTC detection technology?

Advancements in CTC detection technology focus on improving the sensitivity and specificity of tests, enabling the capture of even smaller numbers of CTCs and providing more detailed molecular analysis. These improvements enhance the ability to detect and monitor cancer at earlier stages and with greater accuracy.


Q23. How does DATAR ensure the quality and reliability of its CTC tests?

DATAR employs rigorous quality control measures and advanced technologies to ensure the accuracy and reliability of its CTC tests. All tests are conducted in certified laboratories by trained professionals, following strict protocols to maintain high standards of performance.


Q24. Who should consider getting a CTC test?

CTC tests are recommended for individuals with a known diagnosis of cancer, those at high risk of developing cancer, or patients undergoing cancer treatment who need regular monitoring of their disease. They can also be useful for individuals with a family history of cancer or other risk factors. TruCheck can be used for preventive screening in healthy persons.

 

Test specific questions: 

EXACTA

If two patients have the same histopathological cancer type, and one of them undergoes exacta analysis, can the other patient receive the same treatment as indicated for the first patient?

Just as each patient is unique, so is each cancer. No two patients’ cancers are alike. Even two similar patients (e.g., age, gender, height, lifestyle) with the same type of cancer will have different molecular tumor profiles. Hence, each patient should perform an individual exacta test.

 

Why is it important to start treatment immediately?

Cancer can be very aggressive and may evolve rapidly; the tumor profile can change dramatically over time. If there is a long enough delay, the cancer may gain resistance to treatments, and re-analysis may be required.

 

What kind of drugs will be recommended to the patient?

Only drugs that have been approved by the FDA will be recommended and administered. These will include drugs that are FDA approved for use in the same cancer, other cancers, or other non-cancerous diseases.

 

Are there any follow-up molecular tests to assess the result of recommended therapy?

Molecular tests like our cancertrack analysis allow the oncologist to monitor the therapy in real-time. In addition, the test provides insights into genetic changes of the original tumor to adapt the therapy.

 

TruBlood

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 tumor cells (CTCs/C-ETACs) and nucleic acids (ctDNA) are isolated and comprehensively analyzed. TruBlood is available for the following organs: Breast, CNS, colorectum, lung, pancreatobiliary, and prostate.

 

Is TruBlood applicable in the following cases?

  • Can TruBlood distinguish between adenocarcinoma and squamous cell carcinoma? YES.
  • Can TruBlood determine the grade of the tumor? NO.
  • Can TruBlood be used for hematological 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 the test
  • Turnaround Time: 10 working days (Monday - Friday) from receipt of the sample

 

TruCheck

Are there any age limits for the TruCheck™ analysis? If so, are exceptions possible?

TruCheck™ is advised for individuals between the ages of 40 and 70, as aging is an important risk factor for cancer. However, it can be offered to individuals aged 35-40 years if any of the following risk factors are applicable:

  1. Family history of cancer and/or known carrier status
  2. Presence of risk-associated hereditary germline mutations
  3. Obesity
  4. Type 2 diabetes
  5. History of infectious diseases (HPV, hepatitis B or C viruses)
  6. Documented/significant exposure to specific chemicals or carcinogens

 

What are the benefits of a TruCheck™ analysis?

For TruCheck™, only a simple blood test is necessary. Cancers may be detected that are undetectable by present standard methods. Earlier detection of cancer is associated with greater rates of successful treatment.

 

What are the risks of a TruCheck™ analysis?

The knowledge of being at risk of having cancer, even if it is at an early stage, may have a significant psychological impact on patients. Patients should be aware that they may still need to undergo regular screenings based on established guidelines, as TruCheck™ is not intended to replace standard cancer screenings.

 

CellDx

How long does it take to receive the results and how will they be provided?

The turnaround time, after which the patient or their treating doctor will receive the results, is usually 8 working days from the day the laboratory receives the tissue sample. The test report contains all genomic highlights and lists the particular therapy options.

 

Which analytes are included?

Analytes include SNVs, INDELs, CNAs, Fusions, TMB, PD-L1, MMR, and HRD (Homologous recombination deficiency).

 

Is CellDx suited as a companion diagnostic tool?

Yes, CellDx can provide information if a target alteration is present. Evaluation of therapies needing companion diagnostics across several cancer indications is available, as well as clinical trial matching across all solid tumors.

 

Is CellDx advantageous when selecting an immunotherapy?

CellDx provides informed decisions if an immunotherapy is beneficial using genomic signatures like tumor mutational burden (TMB) and PD-L1 status via immunostaining.

 

CancerTrack

Why is early detection of molecular dynamics of cancer critical?

The molecular evolution of the tumor, including tumor size and molecular diversification, is a continuous process that can progress rapidly. Early detection of recurrence or drug resistance is essential to keep the cancer under control.

 

How frequently is it necessary to perform the test?

CancerTrack should ideally be performed at every important milestone in the fight against cancer, especially when the tumor has disappeared from conventional imaging or when the patient is under follow-up for recurrence monitoring. Typically, this means every 3 to 12 months.

 

What are the sample requirements and turnaround time (TAT)?

The sample requirements include 15–20 ml of blood in DCGL and EDTA tubes. The turnaround time is 8–10 days from the receipt of the sample.

 

Chemo-Scale

What is Chemo-Scale?

Chemo-Scale is a powerful analysis performed on live tumor cells. It reveals which drugs or combinations will be most effective in killing the cancer cells of an individual patient.

 

How can Chemo-Scale help?

Not all drugs work the same for all patients. Some drugs may not prove beneficial and could waste valuable time and resources at a critical point in treatment. Chemo-Scale helps to determine the efficacy of chemotherapy before starting the treatment, providing a more personalized and effective treatment plan. It has shown a concordance of 87.0% when comparing the efficacy of the chemoresistance profile with the radiological response focusing on disease progression.

 

How is Chemo-Scale different from other pre-treatment cancer tests?

While commonly available molecular tests provide information mainly about targeted therapy drugs, Chemo-Scale evaluates the actual response of cancer cells to cytotoxic chemotherapy drugs. It uses a unique approach to identify relevant cells in a short-term culture, enabling accurate advice. Chemo-Scale has been clinically validated with more than 5,000 patients.

 

PINAKA

IS PINAKA™ QUALITATIVE OR QUANTITATIVE?

Pinaka™ is a qualitative test. The test determines positivity based on the presence of CTCs above a numerical threshold, the output is binary, i.e., Positive or Negative.

 

CAN PINAKA™ BE USED TO TEST THERAPEUTIC MARKERS IN A 'TUMOR AGNOSTIC' SETTING?

Test findings of Pinaka™ are intended to be used as per the labeled indications for each biomarker and cancer type.

 

WHAT DOES A 'NEGATIVE' PINAKA™ RESULT MEAN?

A ‘Negative’ Pinaka™ result means that the CTCs do not express the therapeutic marker being tested.

 

HOW FREQUENTLY SHOULD PINAKA™ BE REPEATED?

As Pinaka™ is a non-invasive blood test, it permits longitudinal evaluations over a period of time. The requirement for repeat testing and its frequency would be decided by the treating physician for each patient based on individual needs and treatment response status.

 

DOES PINAKA™ TESTING ENSURE GUARANTEED RESPONSE TO RESPECTIVE TARGETED ANTI-CANCER AGENTS?

As with standard biomarker testing on tumor tissue, Pinaka™ testing is intended to identify individuals who are more likely to respond to targeted treatments. Individual patient’s response is dependent on several clinical, disease-specific and immunological factors.

 

CAN PINAKA™ BE USED TO MONITOR RECURRENCE AFTER CANCER TREATMENT?

Pinaka™ is not intended for recurrence monitoring.