This word you keep using Alternative testing ,doesn't even make sense,FDA approval in not a requirement.The testing is not alternative it is another test.Your way of wording things is suspect.
FDA approval is only required for tests that are marketed to other labs. Single lab tests, like those offered by IGeneX and Advanced Laboratory Services (ALS) do not require FDA approval. Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved.
I don't think the use of 'alternative testing' is problematic. I just assume 'alternative' refers to testing not generally used in mainstream medical practice. I guess people can attach whatever meaning they want to the word 'alternative'. There is a government recommended approach to testing which one can follow or there is 'alternative' testing that is available from individual laboratories. I don't think the use of the word 'alternative' is suspect, it's just a way of defining what is being talked about. Asking sceptical questions about lab tests is entirely reasonable when it comes to health matters.
As for being a CLIA and CMS approved laboratory. Yes, Igenex is CLIA approved.
It is Federal law in the USA that any person or facility that performs lab tests on human specimens for the purpose of diagnosis and/or treatment must have a CLIA certificate. This includes a doctor doing dip stick urine tests as well as labs doing multiple tests like IGeneX.
There are different types of certificates and IGeneX has a CLIA 'Certificate of Accreditation'. What this means is that IGeneX has opted to have a CMS approved accrediting agency perform biannual inspections (for an additional fee) rather than CMS . So IGeneX must follow the accrediting agencies guidelines in addition to the federal regulations.
CLIA certified labs must meet basic standards of operation, record keeping and training. CLIA is more concerned with the performance of a lab in general rather than the performance of specific tests. As already mentioned, IGeneX is not FDA approved because their tests are only used in their lab and not in other labs. Having FDA approval means that the tests have been approved on the basis of clinical sensitivity and specificity. The only requirement for a CLIA approved lab is that the test must detect what is says it does and meet the basic standards of operation, record keeping and staff training. IGeneX meets those requirements, therefore is CLIA approved. That does not mean the test meets any FDA standards as to what would be acceptable sensitivity and specificity. I am pretty sure that is the state of affairs with CLIA despite the quote provided by kungfudao. I googled that quote and got 4 pages all from lyme focused websites and it seems that particular information is somewhat inaccurate and misleading. When I search CLIA alone and CLIA and borrelia, I got a few different hits which matched previous information I have read regarding CLIA accreditation.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6315a4.htm
When evaluating testing options, providers and their patients might be confused by the distinction between Clinical Laboratory Improvement Amendments (CLIA) certification of laboratories and FDA clearance or approval of specific tests. CLIA certification of a laboratory indicates that the laboratory meets a set of basic quality standards. It is important to note, however, that the CLIA program does not address the clinical validity of a specific test (i.e., the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition in a patient). FDA clearance/approval of a test, on the other hand, provides assurance that the test itself has adequate analytical and clinical validation and is safe and effective.
Proper evidence of the clinical accuracy of IGeneX would have to come from external published scientific literature which in the case of IGeneX is very limited. So would a little bit of caution not be warranted when deciding to pay for an IGeneX test or not?
A few years ago there was lots of talk about a CLIA certified lab and people were saying that the lab tests should be trusted on the basis that it was a 'CLIA certified' lab -- gold standard, government approved. That lab was VIP Dx who offered all the tests that diagnosed many people with ME/CFS as being infected with XMRV. We now know these tests were worthless despite their CLIA certification. At one point, VIP Dx issued a press release stating that their tests are 'CLIA approved' and therefore they are certified 'to offer and perform only clinically validated laboratory tests'. In the press release it states that the assays were 'internally validated' and not externally validated. This is similar to IGeneX has done -- internally validated their tests. So no, it appears that maybe being CLIA certified is not the best argument for being tested for lyme by IGeneX. So what is the best argument for using IGeneX? There are a ton of opinions about that, I guess it's up to individuals if they want to trust one lab over another. I guess when all is said and done, you really can't trust any of the tests 100 percent, but some appear to be much better than others for sure.
Perhaps, the best route would be for IGeneX to get FDA approval. If they do work as IGeneX claims then they would become the gold standard with no more questions about them.
