Intended Purpose, Contraindications and Limitations

Ref.-Nr: ZE 002

The PanTum Detect^® kit is a qualitative immunoassay, intended for in vitro diagnostic use in a clinical laboratory environment. The assay detects Apo10 (DNaseX) and TKTL1 epitopes in monocytes and macrophages from human EDTA whole blood. Elevated levels of these biomarkers are associated with abnormal apoptosis, increased cell proliferation and altered glucose metabolism, which may be indicative of the presence of solid tumors.
The PanTum Detect^® kit is intended as an aid in the screening of asymptomatic adults for the possible presence of solid tumors. The test result provides an indication of increased likelihood of solid tumor growth. Test results must be interpreted in conjunction with the individual’s clinical history, epidemiological information and, where appropriate, followed up with further diagnostic investigations such as medical imaging procedures (e.g., PET-CT and/or MRI) for confirmation and localization of potential solid tumor.
Negative test results do not preclude the presence of solid tumors and should not be used as the sole basis for clinical decision-making.
The PanTum Detect^® kit is semi-automated and not suitable for self-testing or near-patient testing. The kit is intended for professional use only by laboratory personnel experienced in flow cytometry. Following export from the flow cytometer, the resulting data (fcs file) is uploaded to the ECA portal, where the Zyagnum Analysis Pipeline software visualizes the data through plots and graphics. No automated analysis or interpretation is provided by the ECA portal; all final data analysis and result interpretation are performed manually by qualified personnel.

• In the case of previously diagnosed malignant tumors and cancers, the PanTum Detect^® test should not be performed until 5 years after successful treatment or cure (surgery, radiotherapy, chemotherapy, hormone therapy, immunotherapy, etc.). This applies to all types of malignant tumors and cancers.
• All currently ongoing cancer treatments and newly diagnosed cancers, including ongoing diagnostic evaluations/procedures.
• Leukemia, myeloproliferative neoplasia (MPN) and myelodysplastic syndrome (MDS) -> test can be performed at the earliest 5 years after remission.

• All acute bacterial/viral infections (including severe colds, flu-like infections, fever, bladder infections, tonsillitis); all fungal infections.
• Acute Shingles/Herpes zoster; Herpes simplex

• No exclusion if asymptomatic/symptom-free
• In the case of chronic inflammatory diseases that occur in episodes, it is advisable to wait 2 weeks after a flare-up.

• Injuries such as bone fractures, deep cuts (deeper 0.5 cm and/or larger than 1 cm), abrasions (larger than 5 cm in diameter), open wounds, severe bruises, torn ligaments, blood in the stool, blood in the urine, acute hiatal hernia (diaphragmatic hernia), acute inguinal hernia (inguinal hernia), acute umbilical hernia (umbilical hernia). After successful recovery, the waiting time must be 8 weeks.
• Operations / interventions such as surgical procedures, endoscopies (such as colonoscopy or gastroscopy); (invasive) tooth removal or dental surgery (incl. root canal treatment).
• Hemorrhoid sclerotherapy, varicose veins/varicose veins. After successful recovery, the waiting period must be 8 weeks.

• Vaccinations of any kind (within the last 4 weeks).
• Iodine-containing contrast agent, e.g. for CT (within the last 2 weeks).
• Dialysis on the day of the blood sample.

• Any treatment or activity that could affect the immune system must be considered as an exclusion criterion. These include steroid, radiotherapy in the last 8 weeks and the long-term use of immunosuppressants after transplants.
• Antibiotics and antifungal drugs in the last 2 weeks; Immunomodulation with corticosteroids, glucocorticoids and colchicine (cortisone/hydrocortisone >5 mg/day, budesonide >5 mg/day) in the last 4 weeks.
• Immunosuppressants with the following active substances: methotrexate (MTX), cyclosporine, azathioprine, tacrolimus, mycophenolate, rapamycin, sirolimus, mycophenolate mofetil, in the last 8 weeks.
• GM-SCF, Molgramostim, Sargramostim in the last 8 weeks.

1. The test does not indicate which type of tumor or cancer it is. A positive result indicates a disturbed cell metabolism, which can also be found in developing or existing tumors. The blood test provides a first indication, not a diagnosis or conformation test. Therefore, if the result is positive, the test is always combined with a suitable follow-up examination. A differential diagnostic clarification is therefore recommended, together with a doctor who accompanies the program, to initiate an appropriate follow-up examination. Which follow-up examination is the right one is decided on a case-by-case basis by a specialized doctor (e.g. MRI or PET/CT). Only the follow-up examination under the supervision of a specialist enables a final diagnosis.
2. PanTum Detect^® may miss solid tumors of certain types, stages, or anatomical sites; clinical sensitivity is limited, so negative results do not exclude solid tumors.
3. The PanTum Detect^® test is not intended to replace any existing cancer screening programs, but rather to complement them.
4. A negative result does not finally rule out the existence of a malignant tumor. It is important that the patient still partakes in all advised regular tumor screenings.
5. The test cannot be used if any symptoms that might indicate the presence of a cancerous disease are present. The test is only suitable for asymptomatic healthy persons.
6. The performance of the PanTum Detect^® test is only assessed for solid tumor pre-screening. It is not validated for aftercare.
7. This test has been validated only for EDTA whole blood samples.
8. It is possible that Apo10 and TKTL1 can develop endogenously. Slight increases of the TKTL1 levels have been monitored in the inflammatory process, in particular, and macrophages can be modulated in many ways. Therefore, the results that are obtained must always be interpreted alongside clinical observations, patient history, and epidemiological information.
9. The test result obtained shall never be the sole basis for diagnosis and/or therapy of patients.
10. The test should be performed in compliance with the regulation on good laboratory (GLP). Users must follow the manufacturer’s instructions precisely when performing the test.
11. Improper sampling, transport, storage, and handling of sample can lead to false results.
12. Indications for samples that may lead to false results are e.g. agglutination of blood sample, <500 events of CD16 event counts (no evaluation) or no clear separation of granulocytes and monocytes population)