MicroGenDX has over 11 years’ experience designing, and validating laboratory developed tests and mitigating risk in supply chains so that we are able to run the test you need when you need it.
ORLANDO, Fla. (PRWEB)
December 21, 2020
In an era when shortages abound, having options is invaluable. Worldwide, labs are facing a scarcity of supplies, as those needed to test for diseases such as sexually transmitted infections (STIs) must be diverted to Covid-19 testing. Enter MicroGenDX, a company specializing in qPCR + Next Generation Sequencing (NGS) microbial molecular diagnostics…a company that designs and set up its own tests and multiplex panels in-house
Indeed, the lack of supplies for STI testing is so severe that in September, the Centers for Disease Control and Prevention advised physicians that if they encounter shortages, then it may be necessary to ration tests for chlamydia and gonorrhea, prioritizing those at higher risk.
In a typical testing situation, lab personnel load a pre-made cartridge with reagents into PCR machines—which typically uses reagents from the same manufacturer. So, when thousands of people are awaiting tests for STIs, pneumonia, and other potentially life-threatening infections, these results are delayed because resources have been shifted to Covid-19 testing. Thus, in the case of STIs, many go undiagnosed, or are clinically treated without testing and in more concerned cases, leading to asymptomatic infected individuals continuing to unknowingly spread the disease.
“MicroGenDX is not as often affected by supply chain issues experienced by other test providers as we design our tests in-house,” says Nick Sanford, Ph.D., Section Director, MicroGenDX, “which means that if there is a shortage of a particular component of the test, we can usually find a replacement from another supplier. Using kits means reliance on every piece of that kit from that kit’s manufacturing supply chain. We have designed our own test so that we have the option of substituting when necessary. MicroGenDX has over 11 years’ experience designing, and validating laboratory developed tests and mitigating risk in supply chains so that we are able to run the test you need when you need it.”
The company’s in-house test, known as a LDT (Lab Developed Test), is regulated and validated by the College of American Pathology (CAP) and CLIA (Clinical Laboratory Improvement Amendments) Act. MicroGenDX designs, validates, and clinically implements its own LDT under its CAP license which means they can use different reagents or suppliers. Thus, MicroGenDX has no shortage of supplies because they are not competing with other labs for supplies.
MicroGenDX can perform a basic STI Panel, a urine test that screens for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). The company also performs a an additional STI (called “Full STI” by MicroGenDX) molecular panel (urine) is able to identify Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium (CT/NG/TV/MG). Both can be ordered directly from the company’s website by a prescriber provider or via MicroGenDX’s telehealth partner, Medcall. MicroGenDX will also add STI testing on top of its Urine, Vaginal, and Prostate Testing services at no additional cost. Results, for the STI tests alone, are returned within 24-48 hours from the time they are received at the laboratory.
The company also accepts the following sample types from healthcare institutions: urine, semen, semen swab, rectal swab, urogenital swab, and vaginal swabs.
Additional information on MicroGenDX’s STI Products is at https://microgendx.com/sti-testing/
MicroGenDX is a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvements Amendments (CLIA) licensed clinical laboratory with more than 12 years of experience in diagnosing molecular-based, laboratory-developed tests. MicroGenDX operates a high-complexity diagnostic laboratory that uses Polymerase Chain Reaction (PCR) and Next Generation DNA Sequencing Technology (“NGS Technology”) – rather than the traditional approach of growing cultures – to determine the presence of, and identify by their genetic markers, specific micro-organisms that are the cause of infections.
MicroGenDX’s technology and mission are improving and saving the lives of patients with serious and often chronic infections and diseases by using the latest science and the most precise diagnostic tool available to identify the cause of infection so that the most effective medicine can be prescribed to treat that infection. Thousands of patients with chronic and often life-threatening infections have benefited from MicroGenDX’s work.
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