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29 March, 2022

New Molecular Assay – Signatera ™

The sooner you find out, the faster you can act.

Early Detection of residual disease at molecular level before relapse.

New Molecular Assay – Signatera ™

Early Detection of residual disease at molecular level before relapse.

Genekor Medical S.A brings to Greece Signatera, a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient who has been diagnosed with cancer to help identify relapse earlier than the standard-of-care tools.

Signatera is the only custom ctDNA test that provides early knowledge with a > clinical test specificity.

Signatera is the first tumor-specific assay for truly individualized cancer care. It identifies and tracks tumor mutations at the source and provides the highest level of monitoring accuracy when determining whether to augment or reduce therapy depending on the results for the presence or absence of the disease over time.

For initial testing, tumor tissue will need to be provided. For the blood draw will require EDTA and Cell- free DNA.

How Signatera helps patients through their treatment:

Personalized Treatment: Each person’s cancer is as unique as their fingerprint. Knowing this information can help you have a more informed discussion with your physician regarding your personalized treatment journey.

Early Detection of Recurrence: Standard care tools cannot detect early the cancer relapse, as a result the question of relapse looms in the back of patient’s mind: Did the treatment work? Is the cancer coming back? Therefore, the knowledge that the assay gives to the physician even 9 months earlier than the standard care tools can help in the immediate decision-making treatment.

In which cases is the Signatera test recommended?

  • Adjuvant setting
  • Use Signatera when the physician decides that patients with Stage II and III Colorectal Cancer need adjuvant chemotherapy
  • When the physician wants to de-escalate/reduce treatment
  • Surveillance setting
  • When the physician wants to detect the residual disease with more accuracy
  • When the physician wants to eliminate the false positive CEA results and to detect the recurrence earlier, while it may still be surgically removable.

What do the Signatera results mean?

A positive test result indicates the presence of molecular residual disease (MRD). Serial sampling can be used to track whether disease burden is increasing or decreasing in response to treatment.

A negative test result indicates that molecular residual disease (MRD) was not detected. Serial sampling can be used to track whether disease titer remains undetectable or increases to catch relapse early.

A positive Signatera result, predicts relapse with overall positive predictive value more than 97%.

Contact Genekor Customer Service to find out more about the test. info@genekor.com, Tel:210 6032138