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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 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
These women die each year despite the pervasive use of mammograms for screening.
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. Following diagnosis of the primary tumor, cancer staging is usually undertaken prior to treatment and often includes a lymph node biopsy. The current method of detecting whether there is cancer metastasis in the sentinel lymph node is by extracting the node and having a pathologist examine it – Sentinel Lymph Node Biopsy (SLNB). These procedures put the patient at risk and often result in post-operative side effects due to the removal of the lymph nodes. Replacing the SLNB with a non-invasive tumor specific in vivo detection test will eliminate unneeded surgeries, improve patient lives and reduce overall healthcare costs.
Through our collaboration with the University of New Mexico we are developing a MagSense™ HER2+ Breast Cancer test as an alternative to SLNB as our first commercial product. Additional indications for breast cancer may follow.
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.
We are collaborating with Weill Cornell Medical to develop a MagSense™ Prostate Cancer test.
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).
We are currently working with the MD Anderson Cancer Center to research and develop a MagSense™ Ovarian Cancer test aimed to detect ovarian cancer years earlier than is achieved by today’s “watchful waiting” by ultrasound.
In addition to use as an aid in the detection and evaluation of cancers, MagSense™ technology may be able to play a significant role in monitoring the effectiveness of cancer therapies. Once the nanoparticles have been delivered to the tumor for initial detection, a subject could be measured repeatedly over the initial course of treatment with little expectation of additional risk because subsequent measurements would require only low magnetic field strength exposures and no additional injections. A reduction of measured magnetic signal would indicate a reduction in tumor size and effective therapy. Unchanged tumor signal strength would indicate ineffective therapy and prompt consideration of different therapeutic approaches. Organizations seeking to evaluate the therapeutic potential of specific targeted therapies using MagSense™ technology are encouraged to contact us.
MagSense™ technology, and superparamagnetic relaxometry (SPMR) in general, are not limited to the detection of one type of cancer or only cancers. MagSense™ nanoparticles could be made using antibodies or ligands to target other types of diseased cells, such as those affected by neurodegenerative or cardiovascular diseases.