PROVIDER FREQUENTLY ASKED QUESTIONS
Pharmacogenetics Testing
What is PGx Testing?
Pharmacogenetics (PGx) Testing is a type of genetic test that examines patient-specific genomic biomarkers to predict how a patient will respond to certain medications to choose the optimal “first-line” drug and/or dose for the patient, with the goal of assuring drug efficacy in the patient whole minimizing or avoiding the risk of an adverse drug reaction.
What does a PGx test do?
A PGx test uses a person’s DNA to help determine how a person responds to certain medications. A PGx test adds one more tool to a physician’s arsenal to help make the best decisions for each individual patient, helping to alleviate the issues caused from the “trial and error” approach to prescribing.
How long does it take to receive results for a PGx test?
How does PGx work?
A PGx test uses a DNA sample taken from swabbing the inside of a person’s cheek (buccal swab) to compare their DNA to known variants. These variants are responsible for differences in the absorption, metabolism, and eliminations of drugs in the body. Based on the variants in an individual’s DNA, their individual response to drugs can greatly vary.
How do you decide which drug-gene interactions to test?
Gravity Diagnostics carefully selects only the drug-gene interactions with the highest level of evidence as provided by the FDA and CPIC (Clinical Pharmacogenetics Implementation Consortium).
What Drugs and Genes are included?
Our PGx panel currently consists of 122 Drugs and 24 genes (please note these offerings are subject to change in 2025). Some of the drug categories included are: Psychiatry, Cardiovascular, Neurology, Pain Management, Gastroenterology, etc.
Our team conducts semi-annual reviews of our report and all relevant data. During this process we add, remove, and change the drug-gene interactions to ensure the information provided in the report is as accurate as possible. We also investigate emerging data in order to add new assays and genes to our report.
Infectious Disease Testing
What Infectious Diseases does Gravity test for?
- Upper Respiratory
- 15 viral targets
- 10 bacterial targets
- SARS-CoV 2
- STI
- 6 targets
How long does it take to receive results for Infectious Disease tests?
Turnaround time varies by testing type. For more information, reach out to your Gravity sales representative or email salesoperations@gravitydiagnostics.com
What are the sample storage, shipping, and stability information for Infectious Disease (ID), Sexually Transmitted Infections (STI), Tuberculosis (T-Spot or QFT)?
Covid and Upper Respiratory Testing
- Samples must be received in the lab within 7 days and can be kept at room temperature. Saliva can be received in the laboratory within 4 weeks.
- Upper respiratory samples are collected using a nasopharyngeal swab.
STI Testing
- Samples must be received in the lab within 7 days in a grey-top preservative tube or 3 days in urine collection cups and can be kept at room temperature.
- STI panel samples require swabbing the patient’s genitalia or through urine collection (dirty catch)
T-Spot Testing
- T-Spot samples must be received in the lab within 52 hours of collection and MUST be kept at room temperature
- Refrigerated samples or samples sent on ice will result in a rejection of the sample
- T-Spot samples are whole blood samples collected and stored in a lithium-heparin tube.
- Samples are later isolated to obtain PBMCs (peripheral mononuclear blood cells)
QFT Testing
- QFT samples must be received in the lab within 56 hours of collection and MUST be refrigerated (4-8°C)
- Samples sent at room temperature will result in a rejection of the sample
- QFT samples are whole blood samples collected and stored in a lithium-heparin tube.
- Samples are later incubated and spun down to obtain plasma.
What does an invalid result mean?
- Covid
- After repeating, the sample did not have enough DNA.
- This is usually due to improper collection.
- After repeating, the sample did not have enough DNA.
- T-Spot
- While interpreting results:
- The count for the negative control (nil spot count) was >10 spots
- The positive control was <20 spots AND the result was negative (Panel A and/or Panel B ≤4 spots)
- There was severe background staining and spots were not able to be counted.
- Invalid results are uncommon (<1%) and may be related to the immune status of the individual being tested. They may also be related to several technical factors, potentially resulting in high background, low mitogen, and high nil results, including:
- Inappropriate blood storage conditions
- Delay in sample transport
- Patient specific conditions
- Laboratory error
- Invalid results are not clinically interpretable and retesting by collecting another sample is recommended.
- Upon retesting, if the test result remains Invalid, other diagnostic tests and/or epidemiologic information should be used to help determine the TB infection status of the patient.
- While interpreting results:
What does a borderline result mean for T-Spot?
While interpreting results:
- Panel A or Panel B spot counts are equal to 5, 6, or 7 spots.
- When a Borderline result is obtained, retesting by collecting another sample is recommended.
- In a large multi-center study by King et al., most Borderline results, 79.8%, resolved as clearly Positive or Negative upon retesting.
- This study also demonstrated that 23% of Borderline results were Positive on retesting, concluding that the Borderline category is clinically relevant and useful in maintaining test sensitivity.
- Upon retesting, if the test result remains Borderline, other diagnostic tests and/or epidemiologic information should be used to help determine the TB infection status of the patient.
What’s the difference between borderline and invalid T-Spot results?
Invalid results cannot be interpreted due to the failure of the test’s positive and/or nil (negative) control.
A Borderline result is a valid test where the spot count is too close to the established test cut-off to classify the result as Positive or Negative.
A T-Spot sample was rejected for a White Blood Cell count <1.8 what should I do?
When a sample is cancelled due to a white blood cell count <1.8, retesting by collecting another sample is recommended.
A count of at least 1.8 is needed to perform the test and obtain accurate results.
Quality Assurance
What certifications or accreditations does your laboratory hold?
Gravity Diagnostics is proud to be CLIA Certified and CAP accredited.
What are the proper procedures for collecting and handling specimens to ensure accurate results?
Clients
I need to check the order status and/or want to make sure a specimen was received:
Call: 855-841-7111 ext 1
Email: info@gravitydiagnostics.com – Please include the specimen ID or Order ID in the email inquiry.
I need to contact my account rep but lost their contact information:
Call: 855-841-7111 ext 1
Email: info@gravitydiagnostics.com; salesoperations@gravitydiagnostics.com
I received an email from Missing Information:
If you are unable to respond to the email and/or have questions about the message received, please contact our customer support team. They will assist is gathering more information and/or resolving the specimen hold for the client.
Call: 855-841-7111 ext 1
Email: info@gravitydiagnostics.com