IMPORTANT
Eligible patient requirements:
- Age: 40y.o. -70y.o. Samples cannot be accepted for patients outside of this age bracket
- Gender: Female

This test requires a blood draw, so please ensure you can refer to a phlebotomist in the clients area before you order this test. (Nordic Laboratories accepts no cost or claims related to any phlebotomy services in the event of sample rejection or failure for any reason. By ordering this, or any test requiring phlebotomy services, you accept any inherent risk and any associated costs.)

Trucheck™ FemmeSafe is a new blood-based paradigm in female multicancer detection, based one simple blood draw.

The ability of detecting cancers at early / localized stages is crucial successful treatments, reduced therapy costs and improved survival rate. Trucheck™ FemmeSafe is a revolutionary blood test that enables early detection of multi-cancer for asymptomatic female tumours with high sensitivity and specificity. 

Recommended for:

• Asymptomatic women who are at high risk or have a family history of breast, ovarian, uterine and/or cervical cancer.
• Women who want to include this test in their yearly health check-up.

To date women have believed that they were well until they are told that they are not, but often this might be in stage III or IV cancer, with treatment and prognosis being hard. The promise of this type of screening is that it provides a baseline in times of wellness, and then if a tumour does develop between the screening period and the follow up test (which should be encouraged to be annually in women over the age of 40), then there would be a high degree of confidence that this cancer would be in an early stage, and thus treatment is likely to be far easier, and with much fewer side effects, and much better prognosis.

The sample is very time-sensitive, therefore we request that you please contact your Practitioner Support Person or contact us: info@nordic-labs.com BEFORE ordering to ensure smooth return of the sample.

About Trucheck™

Around 4.4 million new cancers are detected every year in Europe as well as about 2 million cancer related deaths. Unfortunately, some cancers are detected at advanced stages which necessitate more intensive and expensive treatments which have greater risk of side effects. Detection of cancers at early / local stages is vital for successful treatments, lower treatment costs, lower toxicities and improved survival. Trucheck™ is the culmination of years of collaborative international research and innovation and has been developed, tested and validated on > 40.000 individuals.

Although the aim of the test is to provide peace of mind of no tumour development and confirm a healthy status, Trucheck™'s value also lies in its ability for early detection in asymptomatic tumours, and in doing so, has the potential to reduce the heavy effects of cancer treatment, and in turn reduce mortality.

The last decade has seen a tremendous amount of research in the field of cancer screening. Instead of thinking "cancer", we should begin thinking about "no cancer" status and ensure regular screening so that when a tumour development occurs it can be detected and treated at an early stage. This is particularly pertinent to women at moderate and high risk for developing breast, uterus, ovarian and cervical cancer. Trucheck™ really allows for this status check to become part of a regular health screen and check-up.

Trucheck™ technology

• Trucheck™ detects circulating tumour cells (CTCs) and clusters of these CTCs which are released by malignant tumours, but not from non-cancerous (normal / benign tumour / inflammatory) tissue. Hence CTCs are ubiquitously seen in blood of cancer patients but absent in blood of healthy individuals.
• Trucheck™ FemmeSafe can distinguish between breast, uterine, cervix and ovarian solid tumours which account for over 4 million new cancer cases newly diagnosed each year.
• In clinical studies, Trucheck™ has a sensitivity of 88% in the detection of cancer at all stages and types. Further Trucheck™ has an accuracy of 96% in determining the tissue or organ of origin in positive cases.
• Real-world data has shown a sensitivity, depending on the tumor, of 65% - 89% and a specificity of 96% - 99%.
• Trucheck™ detects cancers irrespective of the extent of the disease, thus even early-stage cancers are reliably observed.

Advantages

In contrast to screening for a single cancer at a time, Trucheck™ FemmeSafe can identify tumour activity of the four major female cancer types via a simple blood draw that may be undetectable by present technologies. Detection at earlier stages is associated with greater rates of successful treatment and improved survival.

Trucheck™ FemmeSafe interrogates CTCs for the molecular imprint of the tumour mass from where the CTCs originated, i.e., Trucheck™ FemmeSafe reveals diagnostically relevant information about the tissue / organ of origin of the tumor with high accuracy. This guides further investigations and reduces diagnostic trial and error.

Methodology 

Immunocytochemistry (ICC)

Markers

C-ETACs (Circulating ensembles of tumour-associated cells)
CTCs  (Circulating Tumor Cells)

Specimen

Whole blood 

Container

• 3 x EDTA tubes (purple colour cap) of 10 ml each

Volume

20 mL

Patient preparation

Not received blood transfusion at least 10 days prior to collection of the sample.
Not positive for HIV / HBV / HCV.

1. Crook, Timothy et al. “Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells.” Cancers vol. 14,14 3341 (2022), doi:10.3390/cancers14143341
2. Akolkar, Dadasaheb, et al. "Circulating ensembles of tumor-associated cells: a redoubtable new systemic hallmark of cancer." International journal of cancer 146.12 (2020): 3485-3494.
3. Ranade, Anantbhushan, et al. "Hallmark Circulating Tumor-Associated Cell Clusters Signify 230 Times Higher One-Year Cancer Risk." Cancer Prevention Research 14.1 (2021): 11-16.
4. Gaya, Andrew, et al. "Evaluation of circulating tumor cell clusters for pan-cancer noninvasive diagnostic triaging." Cancer cytopathology 129.3 (2021): 226-238.