Transforming the management of cancer with personalized testing

Signatera™(by natera.com  laboratories)  is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help identify relapse earlier than standard of care tools.

Medicare and many private insurance carriers now cover the cost of cftDNA monitoring.

Why circulating tumor DNA (ctDNA) for MRD assessment?

• Cancer cells release circulating tumor DNA (ctDNA) into the bloodstream
• ctDNA is a powerful tool that can be measured to assess the absence or presence of molecular residual disease (MRD)
• Dynamic real-time biomarker: the normal half-life is less than an hour

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:

• Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
• Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
• Stage II-IV breast cancer in the neoadjuvant setting, regardless of subtype
• Stage IIb and higher breast cancer in the adjuvant and recurrence monitoring settings
• Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
• For monitoring of response the immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

Clinical applications of ctDNA testing for MRD assessment:

Signatera™ has significant predictive value for long-term patient outcomes

The only significant risk factor in stage II-III colorectal cancer5‑8

In multivariate statistical analysis, MRD status as measured by Signatera™ was the only significant predictor of long-term cancer patient outcomes, after adjusting for all known clinicopathological risk factors including disease stage and lymph node status.1

Will my patient benefit from adjuvant chemotherapy?

When to use Signatera™ MRD test?

Adjuvant setting

• Use after to surgery to evaluate the need for adjuvant chemotherapy
• To personalize and help inform when to escalate or right-size treatment

Surveillance setting

• Detect MRD with greater sensitivity than current standard of care tools
• Use Signatera™ alongside CEA to detect relapse earlier and reduce false positive CEA results

 Determining which colorectal cancer patients benefit from adjuvant chemotherapy isn’t always clear using current standard of care tools. The GALAXY study set out to better understand if a personalized ctDNA assay can aid risk stratification, better than TNM staging for recurrence.

Check out recent findings published in Nature Medicine

Study Overview: CIRCULATE-Japan (prospective large-scale registry)

• 1,039 patients with Stage II-IV colorectal cancer (CRC), enrolled into the observational GALAXY arm of CIRCULATE-Japan, with median clinical follow up of 16.7 months; a subset of patients received adjuvant treatment (ACT) at physicians’ discretion
• Results were analyzed to determine 18-month disease-free survival (DFS), by molecular residual disease (MRD) status and by treatment status.1

Signatera™ Residual Disease Test (MRD) positivity may be prognostic of survival outcomes post-surgery:

• MRD positivity in patients 4 weeks after surgery were associated with a significantly higher risk of recurrence and inferior disease-free survival (DFS) at 18 months of follow-up (HR 10.0, p value <0.0001), regardless of stage.

Medicare Coverage

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:

• Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
• Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
• Stage II-IV breast cancer in the neoadjuvant setting, regardless of subtype.
• Stage IIb and higher breast cancer in the adjuvant and recurrence monitoring settings
• Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
• For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

NB: OutSmart Cancer® has no financial relationship with natera.com laboratories

Other laboratories are emerging that also monitor cftDNA.