| |
WEB SEARCH find: A History of NMPS technology developement...
A revolutionary vision goes to market:
a case history
By 1986, Steve Chubb, having completed a distinguished career as President of Hyland Diagnostics and as chief executive
officer of two biotechnology startup companies (Cytogen and T-Cell Sciences) was ready for an entrepreneurial venture of his
own.
Through friends he heard that a professor at the Massachusetts Institute of Technology was on the track of resolving a
controversial issue that had long puzzled cell biologists.
As Chubb tells the story: “Prof. Sheldon Penman had become fascinated by such complex questions as, what accounts for
and controls cell differentiation? What accounts for cell malignancy? Most other investigators had employed conventional
methods such as extraction and fractionation. The revolutionary vision of Professor Penman and his postdoctoral fellow, Ted
Fey, included a characterization of cells more as relatively rigid three-dimensional structures than as sacs of biological liquids.
Proceeding with these theories, they employed unconventional techniques such as electron microscopy to examine cells, and
produced images of their internal structures that resemble the fiber density of Brillo pads rather than the lightly packed
structures that had comprised previous models. Another, and commercially more useful, observation was that when cells
become malignant the composition of these insoluble proteins changes.”
Meanwhile, Penman and Fey, too, had realized the commercial potential of their discovery and contacted MIT's technology
licensing office. The office confirmed that their discovery — now named nuclear matrix protein or NMP technology — was
both a scientific triumph and the basis of commercially viable diagnostic tests, and filed for broad patent protection on their
behalf. With the licensing office acting as matchmaker, Chubb analyzed the NMP technology. “I quickly concluded that it
easily conformed to my requirements for a commercial winner,” he recalls. “At that time cancer tests and detection methods
relied on indirect structures, such as those found on cell surfaces. The fact that the Food and Drug Administration had
approved virtually none of them was a clear indication not only of the fundamental flaws in these approaches, but of the
enormous market opportunity as well.”
He obtained MIT's support for a license for a new venture, which he named Matritech and which now — ten years later —
stands at the threshold of its first product launch. In late November of 1995, the FDA's immunology devices panel of the
medical devices advisory committee recommended approval of Matritech's NMP22 test kit for the detection of bladder
cancer, on condition that the company provide some additional data, but without the need for another panel meeting. Having
cleared this major hurdle, Matritech only needs final FDA approval and successful market entry to reach its long-awaited
goal. Says Chubb: “We believe that the NMP22 test kit will become as useful in bladder cancer as the PSA [prostate specific
assay] is for prostate cancer.” Already on the market in Europe, the test offers a non-invasive, accurate and inexpensive
alternative to current methods.. And in the Matritech pipeline are products for detecting cervical, colorectal, and prostate
cancers — all based on that initial discovery that the protein composition of the nuclear matrix of cancer cells differs from that
of normal cells. Best of all, thanks to MIT's patents, Matritech expects to have the nuclear matrix market all to itself.
—W. R. R.
Warren R. Ross is the editor of Medical Marketing & Media magazine. |
|
