Nuclea Starts Manufacturing Breast Cancer Test

By Andy McKeeveriBerkshires Staff
Print Story | Email Story
Pat Muraca, CEO of Nuclea, detailed how the test is done the company's Pittsfield headquarters.
PITTSFIELD, Mass. — Nuclea Biotechnologies made its own product to sell for the first time.
 
The company has always had a focus on research and development of pharmaceutical testing but with a recent purchase of Wilex Inc. it's now in the manufacturing business.
 
In that purchase, Nuclea acquired a manufacturing facility and the rights to a blood test administered to breast cancer patients. 
 
Two weeks ago, the company manufactured its first batch of the test under the Nuclea banner and has set goals of $5 million in sales by the end of next year.
 
"This is the first step. It is a big deal," said CEO Pat Muraca on Friday. 
 
The HER-2/neu test is a mix of the patient's blood with antibodies to measure the activity of the proteins produced by the epidermal growth factor receptor. That gene helps control how a body's cell grows and, in breast cancer, the test shows the cancer's aggressiveness.
 
"If the level of protein is elevated, that means you have an aggressive breast cancer," Muraca said.
 
The test is administered similarly to allergy tests by mixing the blood with the antibodies and measuring the reaction.
 
Particularly, the test will help identify patients diagnosed with Stage 1 breast cancer who could have a higher likelihood of having it spread. Muraca said 20 percent of those diagnosed with Stage 1 cancer have it metastasis.
 
"We don't know quite why," Muraca said. "You need to have a biomarkers to identify those patients."
 
Muraca knows the product well. In 1997, he was part of a team working on a similar test of the genes while working for the developers Oncor. That test was more invasive, he said, while this one requires only a blood sample and the laboratory equipment to measure.
 
"This test is what got me interested in Wilex," he said.
 
The test is pretty common, Muraca said, and Nuclea sells the antibodies to pharmaceutical companies, hospitals, doctors and research laboratories. The antibodies are distributed in the United States, Canada and the European Union, he said. 
 
"There are two paths. We can sell these in a kit-based package but we also have the ability to do the test in house," Muraca said.
 
The company has the laboratory equipment at its Elm Street headquarters and can test blood samples upon request from doctor's offices.
 
Giving the product an additional boost, the test is now being covered by Medicare Part B insurance, meaning the company is now being reimbursed. 
 
"The HER-2/neu test has been around for quite some time and this is a new test with it so it wasn't hard to get the approval," Muraca said.
 
While development of these types of tests aren't new to the company, the marketing, sales and manufacturing of the test is. The company plans on spending $3.5 million in marketing and sales to boost those numbers. 
 
Meanwhile, Nuclea will continue developing its own products which could then be manufactured in house.

Tags: breast cancer,   life sciences,   medical,   Nuclea,   

If you would like to contribute information on this article, contact us at info@iberkshires.com.

District Moving On From Allegations Against PHS Administrator

By Brittany PolitoiBerkshires Staff

PITTSFIELD, Mass. — The district is "moving on" from unsubstantiated allegations against two Pittsfield High School administrators, saying there is no threat.

Dean of Students Molly West returned to work last week after being put on leave in December. The Department of Children and Families has cleared West and Vice Principal Alison Shepard of misconduct claims that surfaced after another PHS dean was arrested and charged by the U.S. Attorney's Office for allegedly conspiring to traffic large quantities of cocaine.

School Committee Chair William Cameron on Wednesday emphasized that when such an investigation finds no evidence of wrongdoing, fundamental fairness and due process prohibits taking punitive action simply because of allegations. Reportedly, West was also investigated and cleared in the past.

"The circumstances of Mrs. West being placed on administrative leave don't need to be recited here," he said.

"Social media allegations made against her in December, which then regrettably were widely publicized, were not new. They had been heard, investigated, and found meritless by other school districts many years ago, nevertheless, they were disinterred recently by someone providing neither evidence nor a credible source and then reinvestigated twice in the last three months."

Senior Emma Goetze said she was "appalled, deeply disappointed, and frustrated that an administrator who has been placed on leave, someone who has caused significant discomfort and distress to so many students, has been allowed to return to our building."

"I understand that there is an investigation and acknowledge that this individual was cleared but it feels incredibly unjust to me and to many of my peers that despite everything, this person is being given the opportunity to come back," she said. "It's important to recognize that even though an investigation may have found no wrongdoing, that doesn't change the reality of how this individual's presence makes many students feel."

Investigations led by DCF and retired Superior Court Judge Mary-Lou Rup concluded that there is no evidence to substantiate the accusations.

View Full Story

More Pittsfield Stories