New Data Points to Prognostic & Predictive Value of Nuclea’s Serum HER-2/neu
PITTSFIELD, Mass.--(BUSINESS WIRE)--At the 50th meeting of the American Society for Clinical Oncology (ASCO), Nuclea Biotechnologies presented the conclusion of a recent study which reinforced the findings of previous clinical studies pointing to the prognostic and predictive value of serum HER-2/neu testing for patients with metastatic breast cancer (MBC).
“HER-2/neu can be used for early detection and can help doctors consider additive or alternative therapy strategies based on how a patient is responding to treatment.”
Multiple clinical studies have demonstrated that increasing blood levels of HER-2 are an early indicator of disease progression, particularly with HER-2 positive patients, and that the increase and decrease of HER-2 levels parallels the clinical course of disease. In addition to the clinical value, a patient’s level of serum HER-2 can be used for early detection; reports have shown that elevated levels of serum HER-2 can be measured up to 2 years before clinical signs of recurrence.
“Most oncologists feel that the sooner one attacks a tumor, the better the probability of survival for a patient,” commented Dr. Walt Carney, Chief Scientific Officer at Nuclea. “HER-2/neu can be used for early detection and can help doctors consider additive or alternative therapy strategies based on how a patient is responding to treatment.”
Nuclea, in collaboration with several other groups, presented poster #617 at ASCO. They concluded that singularly elevated levels of the biomarkers HER-2, TIMP-1, and CA IX indicated a shorter progression free survival (PFS) for patients. One objective of the study was to investigate the prognostic and predictive effects of pretreatment serum HER-2 levels in 472 MBC patients. Patients with serum HER-2 levels above the normal cutoff (15ng/ml) had a shorter PFS than patients with serum HER-2 levels below the cutoff.
An increase or decrease of 20% or more from one patient blood draw to another is considered a significant change in the HER-2 level. An increase over 20% reflects disease progression and, by contrast, a decrease of greater than 20% indicates therapy response or stable disease.
“We are excited that a simple blood test can provide doctors with information about patient’s disease progression,” said Patrick Muraca, President and CEO of Nuclea. “Previously, this test has been used primarily for monitoring, but this data demonstrates clinical prognostic value in the course of metastatic breast cancer. The more information doctors have, the better decisions they can make for their patient.”
For more information about the serum HER-2/neu blood test, visit its website, www.her2bloodtest.com.
Nuclea Biotechnologies, Inc. -- is headquartered in Pittsfield, Massachusetts with additional operations in Worcester and Cambridge, Massachusetts. Nuclea has developed and is commercializing unique diagnostic tests for colon, breast, leukemia, lung, and prostate cancer, as well as for diabetes and other metabolic syndromes. Nuclea also performs research leading to novel molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries. http://www.nucleabio.com