We regreat to announce that there are two recent developments that will further hamper patient’s ability to obtain more reliable Lyme testing. First, effective August 11, 2014, Labcorp will no longer run a stand alone Western Blot. They will only run a Western Blot if there is an equivocal or positive ELISA (this is known as a Western Blot reflex). See page 8: https://labcorp/wps/wcm/connect/e831ac0044cfc61b8549dd5dc65848bc/L13226-0714-1.pdf?MOD=AJPERES&CACHEID=046d350044cfb1a59442d7703d82366a The ELISA test has been broadly criticized as unreliable, missing ½ of actual tests. While the CDC’s criteria for a positive Western Blot is likewise insensitive, requiring a total of 7 positive bands (2 IgM Bands and 5 IgG bands compared to a single IgM and IgG band in China), doctors often consider any positive bands in conjunction with a clinical presentation. The second issue involves what are known as laboratory developed tests, or LDTs, including Lyme tests performed by iGeneX and Advanced Labs. As long as LDTs are designed, manufactured, and used within a single laboratory, they historically could be sold without US Food and Drug Administration (FDA) approval. The FDA recently announced that it intends to regulate many of the LDTs. bostonglobe/lifestyle/health-wellness/2014/07/31/fda-plans-regulate-diagnostic-tests-now-exempt-from-oversight/7u7yqVsHaBjOTFW4y0RJwL/story.html In response to the announcement that the FDA will draft guidance in 60 days to regulate LDTs, the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments. “Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law,” said Alan Mertz, President of ACLA. “Under the CLIA framework, a thorough and detailed regulatory process, we’ve seen an explosion of innovation in laboratory diagnostics that has allowed labs to diagnose and measure disease with an accuracy and precision never before possible. This has changed how the medical world views and treats everything from rare diseases to infectious disease to cancer.” acla/acla-expresses-concern-with-fda-guidance-on-laboratory-developed-tests-ldts/#sthash.1M4J8p1y.g2CbUkVR.dpuf The two changes noted above do not help patients, but rather protect those with vested, financial interests in tests that are highly unreliable and insensitive, particularly for areas where there are more diverse strains such as the Southeast. What can you do? Here are a few suggestions: 1. Contact Labcorp to complain about the change at 800-845-6167. 2. Advise doctors of the change so that they can order stand alone Western Blot tests from iGeneX (iGeneX), Stony Brook (medicine.stonybrookmedicine.edu/system/files/LYME%20TEST%20REQUEST%20FORM.pdf, checking the box to list CDC non-specific bands) or Quest (test code 8593 CPT Code 86617). 3. Contact your state politicians to complain about the lack of access to reliable diagnostic tests, particularly for divergent strains found in southern states. To find your state Senators and Representatives: flsenate.gov/Senators/Find myfloridahouse.gov/sections/representatives/myrepresentative.aspx
Posted on: Thu, 07 Aug 2014 21:26:29 +0000
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