NISTA Diagnostic
Pioneering Non-Invasive Breast Biopsy

It is a grim tale, but one that is being rewritten. Every year an estimated two million women undergo breast biopsy. But what is even more disheartening is that the painful, expensive, and risky invasive process is unnecessary for about 80 percent of the patients. The core reason being the screening tools for detecting and diagnosing breast cancer are not conclusive enough. Mammogram, the most common screening test, offers limited inconclusive information and misses out on 13 -20 percent of breast cancer and up to 50 percent of cancer in patients with dense breast tissue. As a result, radiologists are left with no option but to subject the patient to various follow up procedures and eventually the biopsy to make an accurate conclusion. Unfortunately, this over-testing game leaves patients paying a heavy price in terms of health, stress levels, time spent waiting for appointments and test results, and money.

As a beacon of hope for the millions of cancer patients, NISTA Diagnostic offers a new-age solution to make the diagnostic procedure much more accurate right at the first screening step. “We are bringing in a non-invasive scanning method to obtain objective quantitative digital information, which unambiguously reveals pathological status of the tissue. This brings certainty in the results at the very first screening stage,” explains Alexander Lazarev, vice president of NISTA Diagnostic.

The NISTA (Non-Invasive Structural Tissue Analysis) scan uses typical x-ray but instead of absorption NISTA measures Low Angle Scattering, which is a different type of radiology data, which has been completely overlooked so far in medical applications. By contrast with a standard x-ray imaging method, NISTA uses just a pencil beam, with a tiny fraction of the typical radiation dose.

Unlike human judgment prone to error, the data analysis algorithms analyze NISTA structural quantitative data and deliver an accurate diagnosis in minutes instead of days or weeks with current procedures.

We are bringing in a non-invasive scanning method to obtain objective quantitative digital data, which analyzed by a computational algorithm will bring certainty in the results at the very first screening stage

As per the clinical studies carried out, the NISTA method had achieved 95 percent sensitivity and 84 percent specificity when it was first tried over 20 years ago. Since then numerous research groups have studied the idea and confirmed its effectiveness. With the enormous advances in hardware technology and development of global cloud based SaaS platforms scalable on demand NISTA is certain to reach for 99.9 percent sensitivity when introduced to the market. “We believe the NISTA method provides the best accuracy compared to any other test,” states Lazarev.

Notably, the NISTA scan can augment the mammography scan to provide better results. It can be performed in advance of any results from mammography and can either confirm or counter it. Following an initial screening mammogram, if a clinical suspicion arises, the patient can undergo a NISTA Scan, akin to a noninvasive biopsy, to confirm or rule out malignancy. However, if the results confirm a cancer diagnosis, then the patient would go through the standard biopsy procedure, which would now be useful in guiding treatment choices. “Along a cancer patients’ treatment plan, when they go through the various stages of chemotherapy or radiation therapy, our noninvasive scan can keep track of the progress and evaluate the effectiveness of therapies without poking them with needles every month and avoid the spread of cancer,” says Lazarev.

Despite being touted as a viable diagnostic tool for breast cancer, the NISTA scan can be used for skin and prostate cancer. “However, the current focus is to address the unmet need to bring a solution that will help millions of women screened for breast cancer avoid unnecessary pain and suffering and obtain quick and reliable results,” remarks Lazarev. The strategy is to offer a subsidy of up to 100 percent for the clinics' equipment to foster acceptance and start bringing value to patients. With plans underway to start clinical studies at Stanford, NISTA Diagnostic is the pathway to expand cancer knowledge and treatment options.