SCED

is a non-invasive screening aimed at early detection of solid tumors. It is based on simultaneous NGS analysis of ctDNA, circulating tumor cells (CTCs) and white blood cell DNA (germline DNA).
SCED (Solid Cancer Early Detection) is used when HELIXAFE reveals events underlying a possible genetic instability and an in-depth analysis is required. SCED enables a high-resolution analysis of cancer-associated genes through blood sample analysis. The test is non-invasive and can be easily repeated several times at no risk.

The SCED protocol consists of an entry level preventive screening and two successive levels of investigation (SCED HS and SCED 3D).
• The entry level preventive screening analyzes a large number of genes (50), to detect 2800 mutation hotspots associated to solid tumors. The assay allows detecting mutations at a minimum of 1% variant frequency, with 95% sensitivity and 98%specificity. SCED allows identification and amplification of ctDNA. The identified genetic mutations are further investigated using the COSMIC database (Catalogue Of Somatic Mutations In Cancer), a collection of validated cancer-associated mutations based on scientific literature.

The aim of SCED test is to perform a broad-spectrum screening that may indicate the need for further bio-molecular analysis, identifying the gene family to be investigated in detail by means of SCED HS and possibly SCED 3D.

Tissue biopsy SCED
Invasive non-invasive
Specific when the tumor is localized in a site Independent from the original lesion site
May be limited by cancer heterogeneity May reveal cancer heterogeneity
May be difficult to perform Based on routine procedure, such as blood collection
Not of much use if the original lesion has been removed Can be performed at any time during the course of a patient’s life
Repetition of the procedure is not well tolerated Blood collection can be repeated and is well tolerated
When the results of SCED HS have to be confirmed, it is suggested to perform the 3D version. SCED 3D is also recommended in case of:

• Residual disease monitoring in patients that have been previously diagnosed with cancer.
• Therapy follow up in patients with cancer progression and evolution.
• Therapeutic strategy review in resistant cancer.
• Impossibility to perform tissue biopsy i or unknown cancer site.

SCED 3Dis based on simultaneous NGS analysis of ctDNA, CTCs and white blood cell DNA (germline control).

SCED is a screening test for cancer and not a diagnostic tool. SCED cannot be implemented for every cancer type and cannot substitute current validated diagnostic cancer tools. It is possible that genetic mutations in genes other than the ones analyzed by the SCED test can cause cancer onset in a given patient. Furthermore, a negative test result, i.e. when genetic mutations are not detected, does not rule out the possibility of having or developing cancer.

Positive SCED test results must be studied together with the patient’s medical and clinical aspects, familiarity, cancer stage, medical imaging, therapeutic history and other laboratory data. The test results are communicated to patients only in combination with appropriate medical counselling.