20 Dec '13
Oleg Kouzbit, Online News Managing Editor
We’ll take a closer look today at a noteworthy effort being developed at UNN, the largest university in Nizhny Novgorod, in the mid-Volga area. An interdepartmental team of local researchers claims to have come up with new early stage cancer diagnostics that features next gen biochips with at least 20 tumor markers per chip. With just an operational prototype under their belt, the developers are nonetheless confident that when endorsed for use across Russia, the new screening system will help save at least 150,000 lives, otherwise doomed to death through late diagnostics, and keep from hopeless disability an additional 500,000 oncology patients in this country within the first three years of approval. The Nizhny Novgorod team is shooting for the international limelight, too, making inroads into the vast U.S. market and seeking ways to possibly get FDA approval. With U.S. experts tending to believe the Russian system could change American cancer diagnostics as we know it, this UNN development is a project to watch closely.
The new hardware and software diagnostic complex called “ROSE” has been brought into being in a collaborative effort between several scientific teams at the Lobachevsky State University of Nizhny Novgorod (UNN), a major fundamental research and education hub for the entire mid-Volga area since 1916.
In an exchange with Marchmont News Alexander Zemskov, one of the project leaders, said that “the words “affordability and user friendliness” were the guiding lights for the system developers.” The researchers were keen on making the complex affordable for both diagnostic labs and for patients—and have apparently succeeded in doing so (as a test would cost a patient just about $15).
Simplicity and affordability were not all goals to pursue, though. To help the future system work its way through market cobwebs and find customers, the developers were also focused on making the ROSE easy to control by midlevel medical staff, and making sure special software renders test result visualization as crystal clear and unambiguous for physicians as possible.
With all these aspects taken into account, the ROSE ‘fathers’ now hope to incorporate their innovation into Russia’s new early cancer prevention system being put together on the federal level.
At this stage, several operational prototypes have been sent out to a number of medical institutions for rigorous testing.
How it works
“Our technology uses a highly sensitive detection method to determine even the slightest possibility of either first or second stage cancer,” the team stated earlier this year.
At the heart of the project is a proprietary UNN method of pinpointing in peripheral blood samples what is known in medical science as cancer-testis genes whose expression is typically found in tumorous cells. The key ‘scout’ the system looks for in the genes is their messenger ribonucleic acid (mRNA), the main carrier of primary information about proteins’ amino acid sequence in the human body.
Why scout? Because the Nizhny Novgorod developers now seem to know how to make use of cancer-testis gene mRNA as biomarkers to get doctors valuable ‘intelligence’ about the way a tumor advances.
With its sophisticated biochip, capable of sleuthing at least 20 different cancer-testis genes, the ROSE system is said to be able to tap into differences in the way the genes express themselves to not only diagnose cancer cases but also monitor and predict a clinical course for each case, and foresee the body’s response to combined chemotherapy or biotherapy.
The ROSE will come complete with a set of reagents to do the testing, and an optoelectronic detector that registers test results. A special software package will help process and analyze the overall picture.
According to the developers’ estimates, the use of the ROSE in Russia’s cancer screening program will help save at least 150,000 lives, otherwise doomed to death through late diagnostics, and keep from hopeless disability an additional 500,000 oncology patients in this country within the first three years of approval.
In today’s Russia, malignant growths in the human body are the second deadliest natural killer with a 14.3% death rate after cardiovascular diseases that are responsible for an alarming 56.8% of deaths.
Each year, the statistics swells up with more than 500,000 new cancer cases, and the mortality rate within the first 12 months of diagnosis reaches an estimated 29%.
In Russia’s regions where local governments attempt some sort of prevention measures, only 13% of all new cases are detected at a relatively early stage. In other regions, there’s just no screening whatsoever, and new cancer cases are found only when the intruder has done patients irreparable harm.
None of the tumor markers currently used in Russia is sensitive or specific enough to diagnose and/or foresee an oncology disease with accuracy anywhere near 100%, the ROSE team emphasized. The ROSE, however, shows a fairly high 85% sensitivity and 95% specificity, the developers claimed.
With an eye to getting a firm foothold in America
The technology and the ROSE prototype have been showcased in the U.S., too, and are reported to have made quite a splash in high-tech circles there.
Two months ago the developers met a number of interested parties in Maryland. The trip was facilitated by what is known as the US-Russia Innovation Corridor. The innovative Nizhny Novgorod team landed in the International Business Incubator there, and a brief visit resulted in an agreement inked between the Russian developer and a U.S.-based biotech company over a series of joint testing of the ROSE technology in America.
In their feedback after the visit, American experts in Maryland admitted that with the superb sensitivity and specificity the system could show, and following FDA approval of the Nizhny technology—which appears likely if the joint testing effort proves a success—the ROSE has the capacity to alter the modus operandi for cancer diagnostics as we know it, and become its mandatory first stage for millions of Americans.