About 50% of women have dense or very dense breasts. Mammography sensitivity decreases for women with increased breast density because both cancer and dense breast tissue appear white on mammograms, creating a camouflage effect. That means the odds of early detection are reduced.³
Information for Europe and the United Kingdom
With a cancer diagnosis, early detection means better outcomes. It means hope. But when it comes to breast cancer, a significant portion of women have reduced opportunity for an early, life-saving diagnosis.
That’s why we developed Syantra DX™ Breast Cancer.
Syantra DX™ Breast Cancer is a blood test that supports women’s access to early breast cancer detection.
A complementary testing approach
The Syantra DX™ Breast Cancer test is intended to detect an active breast cancer signature and provide information to clinicians that might be used in directing further testing required to make a diagnosis. The Syantra DX Breast Cancer Test is not intended to be used to diagnose breast cancer.
A positive result from the Syantra DX™ Breast Cancer test is recommended to be followed up according to physician recommendations
A new tool helping to detect breast cancer
One in eight women will develop breast cancer in her lifetime.¹
Although many of those women will be detected through screening efforts, a large number of them will not. In fact, 18 percent of breast cancer diagnoses are women below 50-years old,² but in many jurisdictions, routine screening by mammogram isn’t recommended until after a woman turns 50-years-old (for women without symptoms, of average risk).
To make matters more challenging, screening by mammography alone does not detect all cancers at an early stage, particularly in women with dense breast tissue.³ It’s a complex problem that needs a multi-faceted solution.
Syantra DX™ Breast Cancer is a new tool that’s effective in helping to detect breast cancer in early stages, when outcomes are often better.
Syantra DX™ Breast Cancer is a precision medicine tool that measures a panel of gene expression biomarkers from whole blood.
It then uses a software package, developed with machine learning, to interpret data. It provides a molecular approach to breast cancer identification that can help detect invasive disease at early stages.
The Syantra DX™ Breast Cancer test process
An advanced diagnostic protocol
The Syantra DX™ Breast Cancer process involves the collection of a whole blood sample, transportation to a certified clinical laboratory for molecular processing, and result generation through Syantra Inc.’s custom software. A custom laboratory information system has been developed to track samples through the workflow and manage ongoing monitoring of key analytical validation characteristics.
The entire process from sample collection to result generation has been designed, developed and validated to ensure consistency in test outcomes.⁴
The end result indicates whether the sample is
positive or
negative for the signature for breast cancer.
The Syantra DX™ Breast Cancer patient test pathway
Test performance⁴
Syantra DX™ Breast Cancer has been developed over the past decade and has gone through multiple validations, including an ongoing prospective, blinded international study. This study is enrolling women aged 25-80 years around the time of a screening mammogram. Exclusion criteria include previous cancers and breast surgeries in the past year.
Women under 50*
Accuracy
Inferred 98.5% accuracy for women under 50.⁴
Specificity
(ability to detect “no cancer”)
Sensitivity
(ability to detect “cancer”)
Whole cohort: women age 25 to 80 years*
Accuracy
Inferred 92.2% accuracy for women aged 25-80 years .⁴
Specificity
(ability to detect “no cancer”)
Sensitivity
(ability to detect “cancer”)
*Results presented at the San Antonio Breast Cancer Symposium on December 8, 2021 from an interim analysis of IDBC Clinical Study samples from 1,107 participants. Performance metrics are reported for the blind test set with 99.5% confidence intervals (CI) computed through an exact binomial test. There is the potential for false negative and false positive results to occur.
Indications for use
The device (e.g., test) is intended to detect an active breast cancer signature and provide information to clinicians that might be used in directing further detection tests required to make a diagnosis. The Syantra DX™ Breast Cancer Test is not intended to be used to diagnose breast cancer. The target population for the test is informed by the inclusion and exclusion criteria of the clinical performance study (i.e. women between 25-80 with no previous cancer – except for non-melanoma skin cancer – and no breast surgery in the last year).
The test has the potential to improve detection for women with intermediate imaging scores and as an alternative first-line method for detecting breast cancer in women for whom the current standard of care is not recommended. It is a requirement that results from the Syantra DX Breast Cancer Test are interpreted by a qualified healthcare provider. No interventional action should be taken based solely on test results.
Contact us
Interested in learning more about Syantra DX™ Breast Cancer or Syantra Inc.? Contact us through the form below.
Please note.
Syantra DX™ Breast Cancer is a molecular test and should be used as part of the regular screening process. There is the potential for false negative and false positive results to occur. All results should be interpreted by a qualified healthcare provider, and no interventional action should be taken based solely on Syantra DX™ Breast Cancer results.
Citations.
- SEER Cancer Statistics Review, 1975-2017, 2020.
- DeSantis, C.E. et al., 2019. Breast Cancer Statistics CA: A Cancer Journal for Clinicians. 69: 438.
- Seely et al., 2018. Curr Oncol. June 25 (Suppl 1): S115– S124.
- Syantra DX™ Breast Cancer has been evaluated in clinical studies for women between the ages of 25 and 80. The data infers an accuracy of 92.2% for women between 25 and 80, and 98.5% for women under 50. See IDBC study on clinicaltrials.gov: Bundred, N. et al., A whole blood assay to identify breast cancer: interim analysis of the international identify breast cancer (IDBC) study evidence supporting the Syantra DX Breast Cancer Test, San Antonio Breast Cancer Symposium, 21-A-1625-SABCS, presented December 8, 2021, San Antonio, TX, USA.
