Researchers at Ram Group's Israeli bio-sensor division have developed a new molecular diagnostics test for early detection of cancers that takes just ten minutes and uses just a couple drops of blood or saliva. The researchers say that the test is extremely accurate and reproducible, and can be done in the comfort of your doctor's office, or by your dentist, or even by a pharmacist.
According to Dr. Amir Lichtenstein, who is leading Ram Group's Israeli biosensor development team, "Our new generation of biosensor for early cancer detection testing has significant advantages thanks to our new material technology that enables label-free direct detection of ultra-low concentrations of proteins in biological fluids such as blood, saliva, or urine. These sensors are entirely electronic-based and do not use any optical components, which is why they can process and detect the sample in a single step." With any cancer, early detection is key.
Eliminating the need for technicians and running PCR reactions means that the market potential for the Ram Group diagnostics platform is much wider and could eventually be used by the general public in over-the-counter or home-based testing for a wide range of medical conditions and early cancer detection.
Ram Group scientists note that their new single-step diagnostic platform can detect cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) which can be used as a liquid biopsy to assess sensitivity and resistance to therapies as well. Single-step PCR-free detection has not been possible with existing silicon-based sensors in the past. Ram Group is the first company to produce a disposable sensor for rapid molecular diagnostic genetic testing that can detect specific mutations and other biomarkers using a drop of blood from a finger prick or saliva without the need for expensive or complex equipment. The Ram Group Molecular Diagnostics panel is based on synthetic receptors smaller than 1 nanometer that can capture specific proteins in a person's body fluids. These biomarkers enable them to predict with high levels of certainty if a patient has a cancer and the precise stage of the cancer.
A technological issue that no other company or research group in the world has been able to overcome is how to directly detect and measure the extremely low concentration of biomarkers found in early stages of cancer without amplification techniques. Up until now, we have not had sensors that are sensitive enough to detect concentrations as low as femto-Molar (10-15) or identifying a single molecule in 1,000,000,000,000,000 (quadrillion) molecules. Ram Group has finally achieved a major sensor milestone utilizing material developed by Ram Group that exhibits similar properties to those of superconductor materials but at room temperature. While the new material is not a superconductor at room temperature, this revolutionary new material enables electrons to run freely without any scattering or resistance, and have a signal-to-noise ratio of 1 million. The Company is now using these new class of sensors for the first time to detect these proteins and other analytes at the picogram levels and even lower concentrations. The new generation of sensors that Ram Group has developed are fabricated using the proprietary material and will enable the development of sophisticated diagnostics feasible for low-income markets or at the point-of-care and will dramatically change the global healthcare diagnostics landscape.
This is an important milestone in precision medicine with the potential to change the global molecular diagnostics market that is currently valued at over $6.5 billion annually. The researchers expect to begin the clinical trials with select partners using the new capillary blood and saliva test by the end of 2017. If all goes as planned, the new test is expected to achieve EU regulatory benchmarks for CE Certification in 2018 followed by U.S. Food and Drug Administration approval within one to two years. When approved, the test will mark a significant milestone concerning early cancer detection as it would help diagnose cancers early enough to save patient lives when medication and treatment are most effective.
Speaking with Ayal Ram, the CEO of Ram Group he states, "For too long, access to best-in-class molecular diagnostics has been limited to specialized labs and the systems that run them. With our disposable Point-of-Use MDx platform, global accessibility to molecular diagnostics is possible for the first time. The system's unprecedented size and mobility means that it can literally go anywhere, and deliver critical diagnostic test results to support disease determination, treatment, and improved patient outcomes. As in all things impossible; it always seems impossible until it is done!"