An unvalidated Lyme disease test being heavily marketed at those suspecting they have chronic Lyme disease is attracting attention from the medical establishment for potentially putting patients’ health at risk. Advanced Laboratory Services, Inc. launched their test in September 2011, offering it to the public at $595 and taking advantage of a US Food and Drug Administration loophole that allows laboratory-developed tests to be brought to market without any need for approval and, therefore, scientific, peer-reviewed research to validate claims of sensitivity and specificity. Many physicians are increasingly concerned that this company is taking advantage of the vulnerability of Lyme disease patients, especially as the test is not covered by insurance.
Is Premature Marketing of Lyme Disease Test Harmful?
The test in question is a culture which purports to assess the presence of active Borrelia burgdorferi in blood samples sent by patients. This kind of test would be extremely helpful to physicians but there are worries that it has been commercialized prematurely and without scientific data being published to support its validity. There is, as yet, no published research on the test, infectious disease experts have not had the chance to vet the assay and the marketing tactics of the company appear focused on discrediting existing tests and promoting in-house statistics citing 100% specificity.
A New Test for Lyme?
Joseph J. Burrascano Jr, MD, senior vice president of medical affairs and medical director for Advanced Research Corporation, is just one of many voicing opposition to the current state of Lyme disease testing. He notes that a test such as ALS’s would be extremely helpful as it could detect living Borrelia (Lyme disease bacteria), rather than indicating past exposure without being able to discern current infection. The two-tier testing required for a diagnosis of Lyme disease by the US Centers for Disease Control (CDC) has been found lacking on a number of occasions but has yet to be replaced by anything backed by scientific research.
No Research to Support Lyme Disease Test
Dr. Burrascano’s name has appeared on numerous forums citing a 94% sensitivity and 100% specificity for the Lyme culture test with no false positives. The validity of the test is said to have been demonstrated through the ability of samples to grow in Borrelia-specific media, by its characteristic appearance on darkfield microscopy, by reacting to published Borrelia-specific polyclonal and monoclonal immunostains, by DNA polymerase chain reaction (PCR) at 2 different loci, and by direct DNA sequencing. No corresponding data has been published, however, although Dr. Burrascano claims that a paper has been submitted for publication (he did not state which journal).
Unproven Tests Cited to Prove Other Unproven Tests
These methods of testing have previously been called into question by the medical establishment, especially in regards to PCR testing for Lyme disease, the use of unspecified media for culturing bacteria, and polyclonal immunostaining. Citing such tests as proof of validity becomes a circular argument that relies on patients not doing their own research prior to paying for the test. Many patients tired of going without a diagnosis for symptoms that seem to fit the profile for Lyme disease but for whom standard testing has failed to find evidence of infection may be done a disservice by this kind of marketed test. Encouraging the use of such a test is unethical and dangerous as patients and their physicians may give up looking for further diagnosis and apply inappropriate treatments or fail to treat the actual disease.
New York State Clamps Down on Dubious ‘Home-Brew’ Tests
These types of laboratory derived tests are being reviewed by the FDA in order to work on new guidance for regulation. New York State has already implemented extra regulatory requirements, meaning that this latest Lyme disease test is not available in that state. In previous years, the state conducted an investigation into the tests being done for Lyme disease by IGeneX, Inc. with results showing a failure to identify 2/20 positive samples, as well as incorrectly identifying 4/14 negative samples as positive. IGeneX went on to satisfy New York State’s requirements for the Lyme disease test.
The Dangers of the ALS Test
Advanced Laboratory Services relies on promoting the idea that there are considerably more people suffering from Lyme disease in the US than are accounted for in the official statistics from the CDC. While the CDC themselves admit that their figures for reported cases are likely only a fraction of the real numbers of people infected with Borrelia, it is important to remember that ALS, Inc. are encouraging use of an unsubstantiated Lyme disease test that could lead to dangerous treatment for a disease from which patients are not even suffering.
Can You Trust Lyme Disease Research?
Even when the company does publish research it is vital that patients understand that not all journals are equal as regards editorial ethics and stringency. Some journals have no peer-review process in place and are really little more more than marketing opportunities for companies like ALS. Indeed, there has been a review recently into such ‘Predatory’ Open-Access Scholarly Publishers who were disseminating information from at least one scientist found guilty of falsifying data, suppressing data and scientific misconduct in the field of AIDS research.
Costly Unvalidated Lyme Disease Test
Prior to any research being published in any journal to support the use of the test from ALS, the company continues to aggressively market the Lyme disease diagnostic at the price of $595 for “basic culture with polyclonal staining.” Additional costs are incurred for PCR with DNA sequencing, monoclonal immunostaining, and extended culture and all patients pay via credit card or cheque as there is no insurance plan that covers such an unvalidated test.
When Lyme Disease Tests are Appropriate
The American College of Physicians recommends that, to avoid the risk of false positives and harmful treatment, patients with less than a 20% likelihood, pretest, of having Lyme disease should not be tested. Non-specific ailments, including lethargy, aches and pains and headache without a report of erythema migrans (the Lyme disease rash), puts patients below this 20% threshold, meaning that their physician needs to consider all other options instead of simply placating a patient through use of unsubstantiated testing methods. In the long-run, this is the best option for patients as the true cause of their illness is more likely to be discovered and appropriate treatment started earlier than if the diagnostic process veers off towards an ephemeral diagnosis of Lyme disease based on unvalidated tests like the one from ALS.