A biotech company in Pittsfield, Massachusetts is expanding its cancer fighting capabilities.
Nuclea Biotechnologies is now manufacturing and marketing its own cancer detecting test. With the acquisition of WILEX, Inc. of Cambridge in September, the company is now offering the HER-2/neu blood test. CEO Pat Muraca says the test can detect whether people diagnosed with early stages of breast cancer have a chance of it recurring.
“It’s for women that are diagnosed with early stage breast cancer, usually Stage 1, and those women usually do very well with radiation therapy and some surgery,” Muraca said. “The problem is there is a subset of those women that recur within a five year period. They have an aggressive cancer, but it’s missed early on. Not because of anybody’s fault, but because of genetics. The HER-2/neu gene is expressed in protein form when it circulates in blood and you can pick it up using our test.”
Breast cancer is the most frequently diagnosed cancer in women. The American Cancer Society estimates more than 230,000 women will be diagnosed with breast cancer just this year. Blood from 80 patients can be run through the robot driven machines that take about six hours to produce results, a time that includes incubation periods. Kristina Percey runs the test for Nuclea.
“We have different periods of incubation,” Percey said. “We add a detector antibody specific for HER-2, then we add a conjugate and a sub-strait which causes the sandwich reaction to happen in the end causing a color change which is how we read the plate on our plate reader. It reads the color.”
The U.S. Food and Drug Administration has approved use of the test to monitor protein levels for males and females diagnosed with breast cancer.
“After a woman has breast cancer, you want to make sure that serum HER-2/neu level is very low,” Muraca said. “If it’s high then you have a problem. That means you have a recurrence of the tumor somewhere.”
Also, the test is now being covered by Medicare Part B, allowing Nuclea to be reimbursed. Muraca says testing for HER-2/neu has been around for a while. He worked with Oncor to develop tissue testing in 1999, but says this new test is easier to administer and more effective.
“This test that is currently used is tissue-based,” Muraca said. “You have to wait for it to be removed from surgery and you can’t really go back to it. It doesn’t give you any updated information. This test is a blood draw. So it’s minimally invasive. You can draw the person’s as many times as you want. You can test as many times as you want and you get real time information.”
Muraca says the next step for Nuclea is selling the product, something the private company hasn’t been tasked with before. He says the company is currently developing a sales and marketing team.
“So we have two ways to be able to do this,” he said. “We can actually offer it through our clinical lab or sell it as a kit to other hospitals and laboratories to perform it themselves.”
Muraca says each kit costs about $2,200 and, without giving specific numbers, adds that sales have been “robust” so far.