RaDaR® ST Portfolio

Address HR+/HER2- breast cancer long-term recurrence risk months before conventional methods

Hormone receptor (HR+) positive/HER2 negative tumors represent nearly 70% of breast cancer diagnoses and pose a unique clinical challenge. Unlike other breast cancer subtypes, late recurrences are common in patients with HR+/HER2- tumors, with over half of metastatic recurrences occurring 5+ years post-initial diagnosis. The risk of recurrence remains high for these patients for at least 20 years after curative intent treatment. This creates a significant unmet need, as current methods cannot detect breast cancer recurrence until tumors present on scans—missing the critical intervention window when disease burden is minimal and treatment is most likely to succeed.

The test detects early evidence of recurrence, well before the tumor becomes metastatic, detecting 100% of distant metastatic recurrences in a 3.9-year study of 83 patients, with a remarkable median lead time of 12.4 months before clinical detection—providing an unprecedented window to intervene when disease burden is minimal and treatment may be most effective.¹ For high-risk HR+/HER2- early-stage breast cancer patients, RaDaR ST extends vigilance beyond the early years to the long-term survival window by enabling continuous molecular surveillance in the late adjuvant setting, addressing the persistent threat of late recurrence that imaging alone may miss until it's too late.

Additionally, when endocrine-responsive biomarkers indicate high recurrence risk despite anti-estrogen therapy, integrating RaDaR ST testing can refine treatment decisions by detecting and monitoring circulating tumor DNA for more comprehensive risk assessment.

Case Study: Early detection changes the paradigm

A 52-year-old woman, diagnosed with Stage II ER+/PR+/HER2- breast cancer, completed her treatment successfully and showed no evidence of disease for 7 years. Then, during a routine 7-year surveillance, RaDaR ST detected ctDNA in her blood, even though imaging showed nothing unusual.

Her care team responded by scheduling more frequent monitoring, and 3 months later, the intensified imaging found a single bone lesion. She was quickly treated with targeted, local radiation and systemic therapy. The ctDNA cleared, and 18 months later, the patient remains on therapy with no signs of progression.*

*Data on file

Case study: Recurrence monitoring provides early warning

When a 52-year-old woman noticed swelling, pain, and itchiness in her left breast, her family physician ordered imaging that revealed resectable stage III breast cancer with 3 involved lymph nodes, but no distant metastases. Given her high risk for recurrence, she underwent a mastectomy to remove the primary tumor and affected lymph nodes, followed by 12 weeks of adjuvant chemotherapy and 5 years of endocrine therapy. But 6 years after completing her adjuvant therapy, RaDaR ST detected ctDNA in her blood. A breast MRI came back negative, but her clinical team increased examination frequency to every three months. It took 12 months for imaging to confirm that the cancer had returned, confirming what RaDaR ST had signaled a year earlier.

*Data on file

Closing the Surveillance Gap in HPV-Negative Head & Neck Cancer

HPV-negative head and neck squamous cell carcinoma (HNSCC) presents a significant clinical challenge, with many patients developing disease recurrence and fewer than 50% surviving beyond five years. HPV-negative patients face worse outcomes compared to their HPV-positive counterparts, and unlike HPV-positive disease, reliable biomarkers for therapy planning and monitoring treatment response do not exist for this population.

Current head and neck cancer adjuvant therapy monitoring and surveillance cannot answer two critical questions:

• Did surgery remove all the cancer?
• Are there ways to identify disease before clinical or radiographic signs appear?

This gap in monitoring leaves clinicians and patients without the tools needed to detect recurrence early when intervention may be most effective.

RaDaR ST delivers unprecedented sensitivity in detecting HPV-negative HNSCC recurrence, achieving 100% detection of relapsed patients by identifying ctDNA at ultra-low levels of 5ppm—ensuring no patient with recurrent disease goes undetected during the critical surveillance window.

Post-surgical ctDNA monitoring identifies disease relapse a median of 154 days (over 5 months) before clinical confirmation, providing crucial lead time when salvage surgery and radiation are most likely to succeed and before symptoms impact quality of life.

This sensitivity advantage is essential, as nearly one-third of positive samples had variant allele frequencies below 0.01%. It demonstrates standard sensitivity assays may miss a significant proportion of HNSCC relapse leaving patients to present with more advance disease.

Case study: When salvage treatment success rates are highest

When a 60-year-old man noticed a growing lump on his neck, he went to his doctor for evaluation. His medical history included 30 years of smoking and alcohol use, and his physical examination revealed a large, firm mass on the left side. A subsequent biopsy confirmed p16-negative squamous cell carcinoma. Imaging showed the cancer was still localized, and he underwent surgery to remove the mass.

Four weeks post-surgery, despite clear resection margins, RaDaR ST testing detected ctDNA in his blood. Additional surgery was performed within days, and his postoperative ctDNA levels dropped to undetectable. The patient continued regular monitoring with both imaging and RaDaR ST every 3 months. The patient's ctDNA appeared 9 months after surgery but imaging did not detect it until 6 months after RaDaR ST. The residual disease was identified by RaDaR ST months before imaging.*

*Data on file