Most cancers are asymptomatic, growing unnoticed and undetected until the tumor has grown large enough to cause identifiable symptoms. And despite advances made in medical imaging technologies, today’s technologies are still not sensitive enough to detect small tumors. Current medical imaging methods like X-rays, ultrasound, and MRI are only useful in detecting later stage cancers when the tumor has grown to be tens- or hundreds-of-millions of cells. As a result, conventional cancer treatment does not start until a cancer has grown large and developed defensive mechanisms or has already progressed and spread.
Additionally, current medical imaging methods cannot distinguish between benign tumor growths and malignant cancers. This results in missed cancers, exploratory surgeries or unnecessary treatment, and needless patient anxiety. While newer blood-based testing, such as detection of circulating tumor cells or nucleic acids, may provide earlier identification of the presence of cancer, such blood-based testing will necessitate a complementary technology to locate and stage the disease.
A Big Impact
Annual global spending on cancer diagnosis in imaging and pathology is $100 Billion. Yet every year, cancer kills more than eight million individuals. Billions of dollars each year are wasted, and many lives are shattered or lost because cancer is essentially invisible until it is big enough to cause problems. MagSense® technology can change that.
Women Die of Invasive Breast Cancer
Prostate Biopsies Performed Annually
Although the problem of prostate cancer over-diagnosis and unnecessary treatment is well known, more than a million painful and marginally diagnostic prostate biopsies are performed annually in the US.
Ovarian Cancers are Diagnosed Late Stage
Ovarian cancer is known as a “silent killer” because only 20-25% of cases are diagnosed early, when treatment is most effective.
Breast cancer is the second leading cause of cancer related deaths in women and the second most common cancer diagnosed in women with approximately 20% of primary tumor breast cancers being identified as HER2-positive, the most aggressive kind of breast cancer.
Following diagnosis of the primary tumor, prior to surgery and /or treatment, clinical assessment includes palpation and imaging (i.e., ultrasound) of the axilla to look for lymph nodes morphologically (size, shape etc.) suspicious for tumor.
Patients with nodes suspicious for tumor undergo fine needle aspiration (FNA) or core biopsy of the node to confirm the presence of tumor. Patients who are negative for tumor on imaging or on FNA/core biopsy undergo Sentinel Lymph Node Biopsy (SLNB) to confirm whether they are truly negative. Approximately 25% of those undergoing SLNB are positive for tumor.
Precise nodal assessment is an essential component in the management of patients with breast cancer as treatments depend on patient-specific characteristics of the primary tumor, nodal status, and evaluation for distant metastatic disease. Ultrasound, the widely used imaging method for clinical assessment of the axilla depends on the experience of the operator which accounts for the wide variability in its sensitivity and specificity.
There is a need for improved accuracy for the non-invasive axillary imaging methods. A noninvasive and molecularly targeted, tumor specific approach that serves as a differentiated contrast enhancement to the well accepted imaging modality, such as MRI will add value to existing ways of nodal staging as well as contribute to the evolving practice of surgical de-escalation and subsequent clinical decision making.
Prostate cancer is the second most frequent form of cancer found in men with approximately 1 in 7 men being diagnosed with prostate cancer during their lifetime. Early prostate cancer is largely asymptomatic and blood-based PSA testing is not diagnostic. Only 25% of men with PSA elevated above the 4 mg/ml cutoff are positive for cancer. Digital Rectal Exams (DRE) often are inconclusive. Core needle biopsies are often recommended for men with elevated PSA and/or abnormal DRE with more than 1 million biopsies done in the U.S. alone. Unfortunately, there are a significant number of false negative results with the prostate core biopsy procedure. Since the biopsy procedure is both expensive and painful, replacing the biopsy with a simple in vivo test would be of significant benefit, reducing risk, cost, and pain for the patient.
Only about 20% of ovarian cancers are found at an early stage because ovarian cancer is largely asymptomatic. By the time an ovarian cancer is detected by ultrasound it is usually large in mass (100’s of millions of cells) and likely to have metastasized. Testing for CA 125 levels in blood has not proven to be as accurate or as effective at predicting ovarian cancer because other factors/conditions can contribute to elevated CA 125 in the blood. Clinical data suggest that detection of ovarian cancer at an earlier (more localized) stage leads to improved 5-year survival rates (90% for Stage II vs. 39% for Stage III patients).
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