Archives of pathology & laboratory medicine
-
Arch. Pathol. Lab. Med. · Nov 2011
Human epidermal growth factor receptor 2 testing in gastroesophageal cancer: correlation between immunohistochemistry and fluorescence in situ hybridization.
Patients with advanced gastroesophageal cancer have poor survival with current therapy. Human epidermal growth factor receptor 2 (HER2) represents a promising therapeutic target, but the optimal HER2 testing strategy is not yet defined. ⋯ Human epidermal growth factor receptor 2 testing in gastroesophageal cancer can be performed using standard breast cancer procedures and the American Society of Clinical Oncology/College of American Pathologists scoring criteria. Although IHC 0 and IHC 3+ provide clear stratification, reliable separation of IHC 1+ and IHC 2+ may be difficult, especially in biopsy samples. The latter 2 groups are best referred to FISH for definitive classification.
-
Arch. Pathol. Lab. Med. · Nov 2011
ReviewQuality and safety in medical care: what does the future hold?
The rapid changes in health care policy, embracing quality and safety mandates, have culminated in programs and initiatives under the Patient Protection and Affordable Care Act. ⋯ Quality and safety have always been of prime importance in medicine. However, in the future, under health care reform and associated initiatives, a shift in the paradigm of medicine will integrate quality and safety measurement with financial incentives and a new emphasis on consumerism.
-
Arch. Pathol. Lab. Med. · Nov 2011
ReviewCollege of american pathologists proposal for the oversight of laboratory-developed tests.
The US Food and Drug Administration (FDA) announced it will exercise authority over laboratory-developed tests (LDTs). Laboratory-developed tests have traditionally been developed and offered in laboratories as a service to patients and regulated under the Clinical Laboratory Improvement Amendments of 1988 (Clinical Laboratory Improvements Act). Laboratories now face potential dual regulatory oversight from both the Centers for Medicare and Medicaid Services (CMS) and the FDA. The College of American Pathologists (CAP) constructed a proposal to minimize redundancy of agency oversight and burden to laboratories. Modifications to the proposal continue while the laboratory community awaits release of the guidance documents that will stipulate FDA requirements. ⋯ The College of American Pathologists is a leader in laboratory quality and has unique insights into the benefits and risks to patients presented by LDTs. Continued dialog with officials from the FDA and CMS will promote public and private collaborative efforts to assure innovation of diagnostic testing, public information, and patient safety for clinical diagnostic testing.