id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-002626-jzwwses4	Kaul, Karen L.	The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care	2017-07-16		.txt	text/plain	14822	754	40	Clinical laboratories have thus had to develop new assays or modified the existing FDA-approved ones to detect high-risk HPV genotypes in head and neck cancer specimens. The vast majority of reporting laboratories utilized LDPs. 57 KRAS and RAS family gene mutation analysis is also critical in the management of patients with non-small-cell lung cancer (NSCLC) and other tumors, 58 for which FDA approval of kits has not occurred; LDPs or off-label use of kits is required. 74, 75 The FDA approval of anti-EGFR therapies based on clinical trial outcomes data resulted in the need for clinical laboratories to test tumor tissue for the EGFR-sensitizing mutations in order for patients to be eligible for treatment. During those ground-breaking first 15 years of the targeted cancer therapy era, if the laboratory community had been prohibited from providing high-quality, standardized LDP-based testing under existing CLIA guidelines, the negative consequences to patient care in the past and the future would have been substantial.	./cache/cord-002626-jzwwses4.txt	./txt/cord-002626-jzwwses4.txt