MicroGenDX is NOT under investigation by the FDA and is in good standing with CAP (the College of American Pathologists) | MicroGen Diagnostics

MicroGenDX is NOT under investigation by the FDA and is in good standing with CAP (the College of American Pathologists)

MicroGenDX, a high complexity lab based out of Florida, is not under investigation by the FDA and is, and always has been, in good standing with the College of American Pathologists.

The purpose of this post is to address concerns arising from false and inaccurate information that is contained within an article titled FDA investigates lab as tens of thousands of COVID-19 test results in Florida are questioned, published on May 21, 2020 and updated on July 22, 2020 by USAToday.com and other websites. This article has been promoted through social media by competitors of MicroGenDX, and others with agendas pertaining to COVID-19 testing, use of masks, and policy approaches. This article contains false and unsubstantiated statements throughout, specifically pertaining to COVID-19 testing by MicroGenDX.

Our Lab – Southwest Regional PCR Operating as MicroGenDX

MicroGenDX is a College of American Pathologists (CAP) Accredited and Clinical Laboratory Improvements Amendments (CLIA) licensed clinical laboratory with more than twelve years of experience in molecular diagnostics. The laboratory utilizes Polymerase Chain Reaction (qPCR) and Next Generation DNA Sequencing Technology (“NGS Technology”) (rather than the traditional approach of growing cultures). MicroGenDX is considered a world leader in microbial identification utilizing qPCR + NGS technology.

Throughout the laboratory’s existence, MicroGenDX has proven the reliability of its testing through its outstanding results in each of its annual CAP proficiency inspections.  MicroGenDX has published significant data in this cutting-edge area of medical science and supports research with top medical institutions throughout the nation. MicroGenDX has worked with Cleveland Clinics, Mayo Clinics, Rush Institute, Thomas Jefferson University, and many other major universities throughout the US. MicroGenDX has over 30 published works on orthopedic joint infections, urological infections, sinus infections, and wound infections.

MicroGenDX’s reputation has led to the laboratory’s participation with governmental agencies. MicroGenDX was selected to provide Next Generation DNA sequencing for NASA on the Mars Rover and the International Space Station, and the FDA Biofilm Division selected MicroGenDX to conduct research on patient mortality as a result of contaminated endoscopes.

MicroGenDX works with top national opinion leaders in Orthopedics, ENT, Urology, Wound Care, and Infectious Disease.  MicroGenDX’s mission is to utilize the latest science and the most precise diagnostic tools available to identify the specific cause of infection for the most effective treatment. MicroGenDX strives to improve lives and save limbs. Thousands of patients with chronic and often life-threatening infections have benefitted from MicroGenDX’s work; many of whom had previously suffered for months or years because traditional diagnostics had failed. Without a precise identification of the type of micro-organism causing the infection, doctors must make assumptions about what antibiotic or other treatment might be most successful in eliminating the infection.

MicroGenDX COVID-19 Test

 To assist with combatting the COVID-19 pandemic, MicroGenDX COVID-19 Key assay is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior-nasal, and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirates, and sputum specimens from individuals suspected of COVID-19 by their healthcare provider. MicroGenDX submitted a significant amount of data to the FDA (Food and Drug Administration) during the development of its own Lab Designed COVID-19 testing, including stability studies which determine handling and storage requirements for samples. At all times, MicroGenDX has handled COVID-19 test samples in a manner consistent with the stability data for its particular variety of COVID-19 test as required under MicroGenDX’s Emergency Use Authorization (EUA) from the FDA and the requirements of CAP. As long as the sample meets stability standards, and RNA is not degraded, the sample is valid, and the results are reliable.

Different sampling and diagnostic approaches have different storage requirements; these requirements have been determined by stability studies. This media account falsely states that samples used for the MicroGenDX COVID-19 test are required to be handled in the same manner as samples used for the test administered by the CDC. This is incorrect information. The COVID-19 test administered by the CDC has a different storage requirement for samples than other tests, including MicroGenDX’s. The CDC’s refrigeration requirements for samples provided for its COVID-19 test are NOT what the CDC or any other agency requires or recommends for other types of COVID-19 test samples. Sample shipping and storage requirements for each type of test are governed by the specific test’s EUA Authorization and CAP/CLIA sample stability testing requirements.

MicroGenDX believes that all test handling that took place and continues to take place has been done in strict adherence to the FDA’s EUA for its particular type of COVID-19 test and the lab’s CAP certification. To MicroGenDX’s knowledge, the FDA has taken no action with respect to questioning the reliability of its COVID-19 testing services and has not contacted MicroGenDX about an investigation of its COVID-19 testing. MicroGenDX has enjoyed a good working relationship with the FDA and has been quick to respond to any suggestions or comments provided by the FDA. FDA representatives have expressed appreciation for MicroGenDX’s responsiveness and recently thanked them for providing much-needed COVID-19 testing services.

Likewise, the College of American Pathologists (CAP), on the invitation of MicroGenDX, investigated the claims made in the USAToday.com article and has taken no issue with MicroGenDX’s handling of the situation. Since the article’s original publication MicroGenDX has processed over 150,000 COVID-19 tests with no negative comments from either CAP or the FDA.

Supply and Demand Issues During a Pandemic

It has been widely reported by health officials, laboratories, and other sources that COVID-19 testing demand is outpacing the supply for all laboratories.  For example, Quest Diagnostics announced that it is overwhelmed by the surging demand for COVID-19 related services and as a result, turnaround times would be extended, and quick turnarounds would only occur for hospital patients. LabCorp also stated that a delay in testing results should be expected due to the surge in demand. A major factor that contributed to the delays that MicroGenDX experienced in May were caused by the federal government’s decision to sequester laboratory testing equipment and supplies pursuant to the Defense Production Act. The government essentially took the supplies that were necessary to perform tests from laboratories across the country, leading to a nationwide shortage of necessary testing supplies. Here’s an article that details how widespread the supply-chain problems were nationwide at that time:  https://www.360dx.com/clinical-lab-management/amp-sars-cov-2-molecular-dx-survey-shows-supply-chain-issues-hampered-ramp#.XxCSDJNKjxU

Attacks on CEO Rick Martin

As part of the article’s attempt to further attack the credibility of our lab it also inaccurately wrote about an indictment of CEO Rick Martin, in which he was found innocent. The article claims that our CEO was accused of bribing VA doctors while working for another company, Shire. Rick Martin’s inditement had nothing to do with this scandal, but he was instead tied to a podiatrist attempting to name him as a conspirator in this doctor’s Medicare billing fraud. Rick Martin was found innocent of this charge after only 2 hours of jury deliberation; the podiatrist was found guilty. The accusations against Rick Martin were from activities in 2010 and not related to MicroGenDX. The inclusion of these accusations was done out of a desire to build a narrative that MicroGenDX was a questionable lab led by a person who had questionable integrity when in reality MicroGenDX’s lab has over 12 years of experience with an excellent record from CAP.

Rick Martin has served his country honorably as a United States Army officer, been married to his wife Kerstin for 32 years and raised 3 children. He has lived his life in a manner to set an example of high moral standards for his children. The USAToday story and the raising of the indictment has been an unnecessary reminder of a very painful period for Rick and his wife Kerstin. MicroGenDX believes its addition to the article shows a desire by USAToday to sensationalize the dispute between AdventHealth and MicroGenDX.

Sadly, this article has been used as “proof” to spread conspiracies about COVID-19 and has been damaging not only to MicroGenDX, and CEO Rick Martin, but the nationwide fight against the spread of COVID-19. MicroGenDX has processed over 150,000 COVID-19 tests since the article. Neither the FDA or CAP have issued warning letters, as has happened to others, since the publication of this article over 3 months ago despite being in constant contact with MicroGenDX, and working with MicroGenDX to create additional EUA’s, including one for COVID-19 home sample collection. Our continued business and relationship is proof of the approval of these agencies.

MicroGenDX  is pleased to report that it has secured the supplies that it needs to perform COVID-19 tests. Despite this, as many other labs are reporting as well, the unprecedented high demand due to the pandemic may still require its normal 24-48-hour turnaround times to be extended, and your patience and understanding is greatly appreciated.

Please feel free to contact MicroGenDX if you have any questions.


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