Studies show that thousands of women may be receiving the wrong breast cancer treatment because of faulty laboratory reports. More disturbing, this trend was identified years ago. A 2006 study led by Genentech found 14% to 16% of HER2 tests were false positive and 18% to 23% were false negative.
"We all make the assumption that every test is done well. It turns out it's not a correct assumption," commented Lee Newcomer, MD, senior vice president of UnitedHealthcare (UHC).
Large payer tackles problem
A pilot study conducted by UHC found that 12% of their breast cancer patients receiving trastuzumab (Herceptin) did not overexpress HER2. The researchers examined the actual pathology reports and found that many were inaccurate and lacked quantitative results.
"We found that simple human error accounted for this problem; physicians don't willfully disregard the results of tests," Dr. Newcomer said.
He added that UHC now prevents inappropriate therapy by reviewing HER2 test results "as a requirement for coverage beyond the first dose." He added that UHC covers repeat tests.
Dr. Newcomer noted that the quality of pathology interpretation is determined largely by the technical components and experience of the facility.
"Low-volume laboratories seem to have more inaccuracies. This is documented in the references to the ASCO/CAP guideline," he said. [The guideline was published in the Journal of Clinical Oncology (25:118-145, 2007) and is discussed below.]
The first step