Frequently asked questions

MicroGenDX, formerly known as Pathogenius, has been in operation since 2008. In 2017, the company was acquired and rebranded as MicroGen Diagnostics Laboratory or MicroGenDX.

• Rapid turnaround for PCR and NGS lab results, as soon as 24 hours from sample receipt • Utilizes a proprietary database containing over 60,000 bacteria and Fungi • Detects of up to 17 different resistance genes to aid in better antibiotic stewardship • NGS technology offers superior accuracy and specificity to detect microbes • Simultaneous identification of bacteria, fungi, and antibiotic resistance genes in one test • Capable of detecting bacteria even in the presence of antibiotics • Simple and discreet at-home sample collection • Cost reduction and avoidance through better antibiotic stewardship • Enhanced clinical value by reducing identification subjectivity associated with traditional culture methods • Increased patient satisfaction

MicroGenDX testing is based on a proprietary 2-part process that uses two cutting edge molecular techniques: qPCR and NGS. We use qPCR to detect antimicrobial resistance genes that indicate if microbes found in your sample are resistant to certain antibiotics. Then we use Next Generation Sequencing (NGS) to identify the bacteria and Fungi present in your sample. Our NGS is incredibly powerful and can detect over 60,000 different bacteria and Fungi by their DNA. This combination of testing methods provides you and your health care provider with deep insight into the microbial landscape of your infection, allowing for precise diagnosis and treatment. The most common method of testing is called “culturing”, a process where a lab attempts to grow microbes collected from a sample. This process is very time-consuming and challenged by many problems. According to some studies, only about 2% of known bacteria can be grown in a culture and it can take weeks to get a result. MicroGenDX can detect bacteria/fungi by their DNA and is not restricted like culture, providing results in as little as 24hrs from sample with far more accurate results than conventional methods.

PCR is a molecular biology technique that amplifies DNA sequences, enabling precise detection of microbial DNA in patient samples. PCR excels in its ability to detect specific DNA segments, which can enable it to rapidly identify specific bacteria, viruses, and more. PCR tests are designed around panels that look for specific genes or microbes. Each panel can contain multiple “primers” or “targets”, and each one is designed to detect the presence of a specific gene. This design is a major limitation of PCR, since any gene or microbe not on the panel will not be detected. Think of PCR like a flashlight in a dark room: It can light up the areas where you point it, but not the whole room. We use PCR to look for antimicrobial resistance genes and species that are common pathogens in that sample type or application to provide rapid, relevant results to guide clinical decisions.

NGS, also known as high-throughput sequencing, allows for the simultaneous sequencing of millions of DNA strands, providing comprehensive insights into the microbes that make up your sample. While PCR looks for specific culprits, NGS is looking at a database of tens of thousands of potential pathogens and identifying what’s present according to their DNA signatures. If PCR is a flashlight that can only illuminate the area’s you point at in a room, then NGS is like flipping on the light switch for the whole room.

Culture, also known as “Laboratory culture”, is a way to grow microorganisms like bacteria or viruses from a patient's sample in a controlled environment to figure out what's causing an infection. This process involves taking a sample from the patient, growing the microorganisms in a special medium, and studying their characteristics to identify the specific type of microorganism. This helps doctors decide which antibiotics will work best to treat the infection. While laboratory culture is very important in diagnosing infections, it has many drawbacks. Some drawbacks include: 1. Lengthy and often unpredictable time to results - It can take a few days to weeks to get the results, which might delay treatment. 2. Sensitive transport requirements – To preserve the sample in a condition that allows microbes to be grown, samples are extremely time and temperature sensitive. They must be provided to a lab within hours, at controlled temperatures, and cannot be exposed to sunlight, heat, extremely damp, or dry conditions. For samples to remain viable they must be transported to a lab as soon as possible, typically within hours. Unfortunately, in most non-hospital settings, these conditions are rarely met. 3. Limited detection ability – Research shows that upwards of 99% of bacteria can not be grown in cultures. For example, Bacteria that cannot grow in oxygenated conditions (anaerobic bacteria) are extremely difficult to culture and many cultures fail to detect them. Additionally, many bacteria that exist in biofilms or VBNC (Viable But Non Culturable) states are unculturable.

MicroGenDX’s proprietary testing method uses two unique technologies in sequence, and we issue reports from each process as soon as testing is complete. Samples are first run on our qPCR platforms to detect specific microbes and up to 17 different antibiotic resistance genes. As soon as we complete this testing, we issue a report that may also contain biomarker test results, when added-on. Whenever applicable, samples are processed on our NGS machines after qPCR, NGS testing returns comprehensive test results from our database of over 60,000 bacteria and Fungi. Due to recent updates, the test results are now delivered very close to each other but remain distinct in the report(s), separated as Level 1(qPCR) and Level 2 (NGS).

Sensitivity refers to the ability of the NGS to detect microbial DNA when it is truly present in the sample. This includes low-abundance organisms that may be missed by traditional culture, such as anaerobes, slow-growing pathogens or organisms embedded in biofilms. I.e. If a test has 98% sensitivity, then in a group of 100 patients who truly have a specific organism present, the test will correctly identify it in 98 of them. • High sensitivity, fewer false negatives. Specificity refers to the ability of NGS to correctly report when a specific organism is not present, avoiding detection of contaminants, sequencing errors, or organisms that aren't truly in the sample. I.e. If a test has 98% specificity, then in 100 patients who do not have the organism, 98 will correctly test negative. • High specificity, fewer false positives.

Some medications, like anti-herpes drugs, may impact test sensitivity by reducing viral shedding. Some antibiotics can degrade microbial DNA, and impact test results. It's essential to follow any instructions provided by your healthcare provider regarding medication usage before testing. If you are unsure of your medication’s potential impact on test results, contact our customer service team. Always consult your healthcare provider before changing or suspending any medications.

Yes, MicroGenDX offers testing for parasites through the GI Test Service and a range of sexually transmitted diseases through various tests. STI testing is available through the Rapid STI test kit or can be chosen as an add-on to many of our test kits.

UTIs may involve multiple organisms, and NGS technology can detect them simultaneously, offering comprehensive insights into the infection. Traditional methods encounter many limitations that do not affect NGS. Culture, for example, is only capable of detecting about 2% of all known bacteria and struggles to detect bacteria embedded in biofilms or those in VBNC (Viable But Non-Culturable) states.

Viable bacteria can be distinguished by the presence of live DNA, which remains stable for weeks after collection.

Lab reports can be accessed through the MicroGenDX patient lab portal or your account on the patients.microgendx.com website.

If you need help interpreting your test results, MicroGenDX has resources available to you. Consider watching our “Reading a MicroGenDX Lab Report video” or contacting our customer service team. Although we are not medical providers and cannot diagnose or treat, we excel when given opportunities to help customers better understand their reports.

We offer suggestions for antibiotics that could help treat each type of bacteria we find. These suggestions come from trusted sources like the Sanford Guide and Johns Hopkins Guides. It's also important for your doctor to check your local antibiogram, which tracks which antibiotics work best against germs in your area.

NGS has the ability to detect bacteria even if they are mutated beyond the detection capabilities of PCR. This is because PCR detects organisms using specific gene primers, if those primers are mutated, the organism will not be detected. NGS is also not constrained by panels in the way that PCR is, allowing NGS to detect a far larger range of bacteria and Fungi.

MicroGenDX accepts various samples, including urine, swabs, blood, fluid, tissue, and fecal matter, with specific guidelines provided for each test service.

Detailed instructions for sample collection are provided with each test kit to ensure accuracy and prevent contamination.

Negative results may occur due to various factors, including sample quality and the presence of biocides or host DNA. However, they may also be indicative of a lack of infection (depending on the sample collection site). Please consult your physician before interpreting such results.

If you have received a negative or inconclusive report, please contact our customer service team at 1-855-208-0019. We can help you understand your results and what may have caused your inconclusive result.

Patients can order test kits online through this website (with telehealth support) or by calling (855) 208-0019.

Results can be accessed through your website account or by calling MicroGenDX at (855) 208-0019.

Test kits include all necessary collection materials and a prepaid FedEx Priority Overnight label for convenient sample submission. Simply take the specimen box and drop it off at your nearest FedEx Dropbox. If you need help finding your nearest FedEx Dropbox, click HERE

Ideally, antibiotics should be discontinued 48 hours prior to testing, unless otherwise instructed by a healthcare provider. Always check with your health care provider before discontinuing any medications or altering your regimen.

While some medications may impact test results, pain medication typically does not affect samples. If you have questions about specific over-the-counter medications, feel free to contact our Customer Service team.

In the U.S. medical system, physician authorization is necessary for legal compliance and accurate interpretation of test results.

Yes, following illustrated instructions for sample collection ensures accurate test results. Failing to collect samples according to instructions could decrease the quality of results due to contamination or even lead to a negative (no organisms found) test result.