American Association for Clinical Chemistry
Better health through laboratory medicine
September 2010 Clinical Laboratory News: Regulation of Lab-Developed Tests

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September 2010: Volume 36, Number 9


Online-Only Expanded Survey Results and Comments

Does your lab perform LDTs even when there are FDA-approved kits available?
Yes  22%
No  55%
Not sure  2.4%
Not applicable  20.5%
Labs’ ability to develop LDTs improves patient care.  
Strongly agree  43%
Somewhat agree  46%
Somewhat disagree  9%
Strongly disagree  2%
New York is known for requiring review of LDTs above and beyond oversight of accreditors. Do you accept samples from New York for your lab-developed tests?
Yes  21%
No  58%
Not sure  21%
If so, is New York regulation of LDTs a barrier?
Strongly agree  17%
Somewhat agree  37%
Somewhat disagree   22%
Strongly disagree   25%
If so, do you believe that the level of review by New York of LDTs is necessary and appropriate?  
Strongly agree 28%
Somewhat agree 42%
Somewhat disagree 18%
Strongly disagree 12%


Reader comments

“It is about time that the FDA has decided to reign in the wild, wild west of clinical diagnostic tests. The 2006 Genentech study on Her-2Nu testing is a landmark case in point.”

“I think there needs to be more stringent oversight of LDT by CAP or CLIA rather than FDA.  FDA does not have the capability to handle reviews in a timely fashion. I think for profit laboratories should be the first to have increased scrutiny as they are more likely to sacrifice quality for lower costs/increased throughput.”

“We use many chromatography techniques for drugs that have greater specificity than FDA-approved immunoassays. The FDA approval does not make these assays better than ones we already use. FDA-approved assays for 25-OH vitamin D cannot determine the difference between ergocalciferol (D2) or cholecalciferol (D3)—two very different compounds. Our HPLC assay can easily determine the concentrations of both independently.”

“Lab developed tests are good when there is no other type of testing available and validated using CLSI standards. Reasonably, the FDA should review LDTs in the same manner that tests offered through laboratory vendors are reviewed. The main focus should be patient safety.”

“I attended the FDA public meeting on oversight. Many stakeholders were present. The consensus was for the FDA to set up an advisory board of experts before implementing any oversight, to use third-party evaluators already in place (CLIA, CAP, etc.), and to grandfather labs with LDTs approved by the New York Department of Health. The DTC labs fought for their autonomy.”

“Our healthcare practitioners spend thousands of dollars for LDTs when an FD- approved test would serve the patient better.  I have a problem with our reference lab’s performance of these types of tests because I do not believe the proper over sight is there.  I have been in the medical lab field for 45 years, and if a doctor ordered one of these LDTs for me, I would refuse to have it done.  It is all about the money!  This is one of the problems with the cost of healthcare in the U.S.”

“FDA oversight of one of our LDTs would significantly hinder its use here and significantly affect critical care medicine. No area or national reference lab offers our LDT.”

“Considering the length of time it takes for the FDA to approve anything, labs such as mine who develop more than 75% of their tests will be significantly hindered. Most of my LTDs are validated constantly using PT samples, many from Europe. I think the FDA could monitor and control these tests closer if they reviewed data such as this.”

“FDA very well could involve themselves in commercial labs testing. However, I think it would kill innovation to do the same in the academic environment where we are the interface between basic science and new clinical advances.  We need the opportunity to develop the next generation and this will only occur where that intellectual brain trust is actively involved - ie, the academic clinical lab.  This works well under the current certification programs, and layering on the FDA will only add expense and delays with no benefit to the practice of medicine. Large commercial labs are another story.  Their bread and butter is the commodity testing— large volumes in factory labs.  They should have more oversight and regulation since they often have skeletal thin directorship.”

“As a New York State lab, we would welcome oversight by the FDA since this levels the playing field with respect to competitors outside of the state that do not have to go through the same validation process.”

“Size matters in this discussion. We are a small lab which stringently monitors the quality of our LDT. If we were forced to submit to the FDA all sorts of validation and documentation above and beyond our present CAP requirements, we would be forced to abandon this test much to the determent of those clinicians who rely on us for testing not available elsewhere.”

“Since DTC tests are LDTs, the most suitable agency to oversee and regulate this category is CMS. As there is no current provision for the oversight or regulation under CLIA, a new amendment would be required and developed from the input of those who have experience in the field.  For laboratories offering LDTs to consumers, a separate CLIA inspection and certification could provide the oversight and regulation that this category requires. The FDA’s involvement in this area already includes their review and approval of the analytical methods and systems to be used in delivering the LDT's.  The FDA may also be vital in providing the review of all related labeling and marketing materials for the LDTs once the method has been deemed suitable through the CLIA LDT inspection of the method validation. This FDA review would be somewhat equivalent to the DDMAC process for pharmaceuticals, in which the review is focused on product claims. Using this approach, the FDA asserts itself as the agency concerned for consumer safety, and CMS continues to oversee its specialty in laboratories.”

“FDA should follow the New York State precedent for thorough validation of lab-developed or lab-altered tests to ensure the accuracy and reliability of the test results. Without this, what standardized assurance do clinicians and patients have that test results are accurate and reliable?”

“I agree that LDTs need to be held to strict standards to ensure quality of testing and protect patient safety.  I would much prefer to have CAP oversee these tests using the tiered system they have proposed.  As the primary accrediting agency for laboratory services, CAP seems ideally suited to perform this function.  FDA oversight of LDTs would increase costs and delay implementation so significantly that most private hospital labs would not be able to use LDTs.  We cannot afford any increases in our operating costs.”

“Doing away with LDT would severely hamper labs in providing quality services to physicians and patients in the U.S.  FDA would do better to examine and eliminate "waived POCT" in the medical setting.  Current FDA regulations covering in vitro diagnostics are responsible for putting U.S. clinical laboratories in a one down position compared to the rest of the world.”

“We are a clinical toxicology and pharmacology laboratory. Most of the products we offer are laboratory developed tests to detect or monitor drugs in urine. In order to remain competitive, the process of developing these tests for use to the public should not be slowed by the FDA approval process. We follow all validation regulations as requested by CLIA, which is consistent in keeping with patient safety. If the process to bring the test to the public is slowed, patient safety may be impaired.”