Clarient, Inc, a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, announced that privately held, Waltham, MA-based Minerva Biotechnologies has granted it the exclusive right to develop and commercialize a test that identifies the MUC1 protein, a biomarker researchers believe may be implicated in the spread of many cancers, including breast cancer.

"We believe MUC1 has the potential to have an impact on cancer diagnostics," said Clarient chief executive officer Ron Andrews. "It's early in the evaluation process, but it may have significance in diagnosing, selecting therapy, and monitoring therapeutic efficacy in solid tumours. Early research has also demonstrated that MUC1 may play a role in developing resistance to cancer drugs, which means if you can block MUC1, you may be able to overcome resistance to a drug and, once again, offer that therapy."

Andrews said the relationship with Minerva and its biomarkers fits very well within Clarient's business model.

"Our growth model includes collaborating with academia and innovative companies, wherein the value of new biomarkers are defined," Andrews said. "Once validated, we can move forward with commercialization by taking the test to market via our robust national pathology distribution network. That is exactly what we are doing with the MUC1 test."

Commenting on the license arrangement, Dr Cynthia Bamdad, founder and chief executive officer of Minerva Biotechnologies, said, "We are very excited to have Clarient as our commercialization partner for our MUC1 diagnostic test. The MUC1 story has garnered a great deal of attention recently with Minerva's discovery that MUC1 is in an altered form, called MUC1, on embryonic stem cells and on cancer cells. This is the first direct evidence that cancer cells grow by hijacking a normal stem cell mechanism that usually exists in a dormant state on healthy adult cells. Minerva has compelling evidence that cancer cells that grow resistant to anti-cancer drugs do so by producing more MUC1."

Dr Bamdad continued, "The November issue of the journal Breast Cancer Research and Treatment includes our article outlining how the blocking of MUC1 can reverse an acquired resistance to cancer drugs, increasing the therapeutic choices for certain solid tumours."

Clarient estimates it would take about a year of further development to thoroughly evaluate the predictive value of measuring an amount of MUC1 in a patient's sample. Currently, there is no MUC1-targeting drug available, but in the long term, the test could identify patients who would benefit from a MUC1-disabling drug. The two companies expect to collaborate on critical studies to validate the clinical utility of the marker as well as supporting papers and scientific presentations at major oncology symposia.

"We continue to make definitive progress on what biomarkers are implicated in which cancers, so we need to be proactive in evaluating new markers, such as those implicating MUC1," Andrews added. "We spent the first five years building a commercial channel that could deliver complex cancer testing information into every community in the US, and building out a base menu of services to support the community pathologists. Now we are leveraging our channel to strengthen our menu of proprietary tests for the key cancers we serve. If MUC1 turns out to be as valuable as some believe, especially for women who have developed a resistance to certain targeted therapies, it would be a significant product in our arsenal."

Clarient combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer.

Minerva Biotechnologies uses its proprietary nanoparticle technology to develop novel therapeutic and diagnostic agents that target the MUC1 growth pathway.