HomeJuly 7, 2014: Regarding the Anti-Dopamine D2L assay. Thank you for your patience as we work on resolving this reagent shortage. Due to the complex and unique nature of these assays and reagents, significant time has been required to reproduce this reagent. A new, transient cell line has been created and the D2L antigen is currently being expressed, characterized and validated, in anticipation of the production of a new, stable cell line. We currently anticipate that the D2L assay should be available by September 1, 2014. Once available, all past orders will have the D2L assay performed and reported unless otherwise requested. However, the current 4 assays of the 5 assay panel can provide significant value should any single assay result be elevated. If you have any questions please contact us at (405) 239-5250.
Moleculera Labs provides personalized clinical testing services for individuals suspected of suffering from PANDAS/PANS, which are treatable neurologic conditions that may be associated with motor tics, obsessive compulsive disorders (OCD) and sometimes Autism Spectrum Disorders. This perplexing neurologic condition is believed to be associated with an autoimmune response triggered by commonly occurring infections which result in a patient’s antibodies targeting neurologic receptors in the body.
Over a decade of PANS and PANDAS testing, research has led to the development of the Cunningham Panel™, a set of 5 clinical assays which serves as an aid to the physician in the diagnosis of these conditions. Moleculera Labs is continuing to work with researchers, patients and physicians to help understand the underlying biology of these autoimmune and neurologic conditions. The overarching goal of Moleculera Labs is to assist children and their families to help restore an improved quality of life.
We are a fully certified clinical laboratory registered with CLIA* and approved by COLA into their Laboratory Accreditation Program. These are U.S. state and federal accrediting agencies that oversee and monitor testing quality within the clinical laboratory industry. However, some states require additional licensure to be able to test specimens from residents in their state. We are pleased to report that we have obtained licensing in California, Maryland, Florida, and Rhode Island. Unfortunately, at this time we are unable to test specimens from patients residing in New York state until we receive their approval.
We are working diligently with the state of New York to meet their additional requirements. Once we receive the additional licensure we will post that information on this website. Additionally, we are working to establish accreditation which will allow us to test specimens from outside the United States. Once that is accomplished we will post that information on this website also. Thank you for your patience as we work to secure approval for testing of your children!
Updated July 21, 2014:
We are currently authorized to receive specimens and perform testing in 49 U.S. states. We continue to work with New York State to seek licensure approval. We will post more information on this as it is available. We apologize for the delay and thank you for your patience as we work to secure approval in New York. Should you have any questions, please contact us at (405) 239-5250.
What is PANDAS/PANS?
PANDAS (Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections) is an autoimmune disorder believed to be associated with, and initiated by, a streptococcal infection. The disorder presents itself in many forms, but typically can manifest through sudden onset of Obsessive Compulsive Disorder and tics symptoms. PANS is an acronym for “Pediatric Acute-onset Neuropsychiatric Syndrome” and is the more recent term designating this condition, irrespective of the etiologic or infectious agent triggering the autoimmune condition.
What is the Cunningham Panel™?
Over the past decade, Dr. Madeleine Cunningham and her laboratory at the University of Oklahoma have developed and performed a unique panel of autoimmune identification and cell stimulation tests, to aid the physician in the determination of a patient’s PANDAS and PANS diagnosis.
Currently the panel is comprised of five different tests, four of which measure the level of circulating antibodies directed against different neurologic receptors or antigens, and one assay which measures the immune stimulating intensity of the patient’s serum against neuronal cells. The collective results of the panel of 5 tests will provide an assessment as to the anti-neuronal and autoimmune state of the patient at the time of testing. The physician is provided a composite report containing the 5 assay results, each compared to normal controls. The collective results can aid the physician in determining a proper diagnosis and support the appropriate treatment decision.
Currently, the Cunningham Panel™ does not include testing for streptococcal or anti-streptococcal antibody titers in PANDAS. Our goal at this time is to assist the physician and family by determining if there are elevated anti-neuronal antibodies and neuronal cell activating antibodies currently circulating in the blood, rather than attempting to identify the infection related to the autoimmune condition. PANS is also associated with other infections. Therefore, in the future we may add additional tests to the Cunningham Panel™ that would assist in identifying these infectious agents.
*CLIA Registration Number 37D2052130
COLA ID: 24220