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Frequently Asked General Questions

What is genetic testing?

Genetic testing uses laboratory methods to look at your genes, which are the DNA instructions you inherit from your mother and your father. Genetic tests may be used to identify increased risks of health problems, to choose treatments, or to assess responses to treatments.

What can I learn from testing?

There are many different types of genetic tests. Genetic tests can help to:

  • Diagnose disease
  • Identify gene changes that are responsible for an already diagnosed disease
  • Determine the severity of a disease
  • Guide doctors in deciding on the best medicine or treatment to use for certain individuals
  • Identify gene changes that may increase the risk to develop a disease
  • Identify gene changes that could be passed on to children
  • Screen newborn babies for certain treatable conditions

Genetic test results can be hard to understand, however specialists like geneticists and genetic counselors can help explain what results might mean to you and your family. Because genetic testing tells you information about your DNA, which is shared with other family members, sometimes a genetic test result may have implications for blood relatives of the person who had testing.

What are genetic disorders?

A genetic disorder is a disease caused in whole or in part by a change in the DNA sequence away from the normal sequence. Genetic disorders can be caused by a mutation in one gene (monogenic disorder), by mutations in multiple genes (multifactorial inheritance disorder), by a combination of gene mutations and environmental factors, or by damage to chromosomes (changes in the number or structure of entire chromosomes, the structures that carry genes).

What is pharmacogenomics?

Pharmacogenomics uses information about a person's genetic makeup, or genome, to choose the drugs and drug doses that are likely to work best for that particular person.

What might pharmacogenomics mean for you?

Pharmacogenomic research has changed the "one size fits all" approach to drug assessment and opened the door to more personalized approaches to using and developing drugs. Depending on your genetic makeup, some drugs may work more or less effectively for you than they do in other people. Likewise, some drugs may produce more or fewer side effects in you than in someone else. In the near future, doctors will be able to routinely use information about your genetic makeup to choose those drugs and drug doses that offer the greatest chance of helping you.

Can I request my own laboratory tests?

Individuals cannot order tests themselves, due to state regulatory requirements, but if you are interested in having a specific laboratory test performed, please ask your healthcare provider if the test is appropriate for you, and if he/she can order the test(s) for you. To facilitate your discussion, it might be helpful to bring your healthcare provider a printed copy of the brochure or page from our website where you learned about the test.

How will my healthcare provider use the information from Gulfstream to treat me?

The diagnostic reports we provide offer one piece of the information that your healthcare provider can use to create an individualized treatment plan for you. He/she will use our analysis to help guide the selection of the medication or treatment that best meets your specific needs. With Gulfstream, your healthcare provider can identify which medications may be more effective and may be less likely to have unwanted side effects.

How reliable are Gulfstream’s test results?

We hold compliance and lab safety to the highest standard, producing accurate qualitative and quantitative analyses in the shortest span of time, without compromising quality. We stand at the forefront of toxicology, clinical chemistry and pharmacogenetics developing new methods in partnership with world-class institutions delivering results you can trust.

Are the results of my Gulfstream diagnostic report confidential?

Yes. Gulfstream takes privacy and security very seriously. That’s why we analyze all diagnostic samples at our own accredited lab, so we can ensure the quality and security of your test. Your genetic information is private and protected through various federal laws including HIPAA (Health Insurance Portability and Accountability Act) and GINA (Genetic Information Nondiscrimination Act) that ensure the security of your personal and genetic information.

May a minor be tested?

By law, minors may be tested with permission and consent granted by parent or legal guardian as applicable by law

Can I receive a copy of my test results?

By law, lab results are reported only to the ordering physician or other authorized ordering healthcare provider. Patients are encouraged to obtain their laboratory test results from their doctor.

Is Informed Consent Required?

In some states existing laws require healthcare providers (HCPs) to obtain informed consent for genetic tests. Due to changing state laws and regulations, it is the HCP’s responsibility to verify whether they practice in a state where informed consent is required prior to ordering genetic testing.

How does Gulfstream support Managed care?

Our diagnostic tests are designed to help healthcare providers make more precise decisions, resulting in more effective treatments, more appropriate screenings, and ultimately improved patient outcomes. Gulfstream’s precision leads to an overall cost savings to the healthcare system by either reducing upfront spend, eliminating unnecessary therapies and related comorbidities, or by providing clinical improvements in disease prevention, survival, and patient satisfaction. Further our trusted results help patients to better manage their care, understand their options, and pursue appropriate medical and healthcare options suitable to their financial situation.

What is a Letter of Medical Necessity?

A healthcare provider may include a Letter of Medical Necessity (LMN) with a pre-authorization request, claim submission, or appeal to facilitate the insurance review process for the benefit of the patient. Our experience with insurance companies is such that we encourage healthcare providers to cover as many of the following points as possible that are applicable to the patient:

  • Explanation that the requested genetic test has been ordered by a physician
  • Explanation of the medical necessity for the test requested
  • If family history is cited, give as much family history as possible
  • Patient’s diagnosis and prognosis
  • Explanation that genetic test is recognized as appropriate for inclusion in this patient’s treatment regimen
  • Treatment plan, including specific statements about anticipated impact of the genetic test on the medical management of patient

If the Insurance Billing option is selected Gulfstream will verify coverage and determine the patient’s financial responsibility. If the patient’s total financial responsibility will exceed $375 for any reason, including co-insurance, deductible, or non-covered services, we will contact the patient directly to discuss the specifics of the case and options available to the patient before proceeding with the testing process. If their total financial responsibility will NOT exceed $375, your patient will NOT be contacted, and sample processing will begin immediately. Note: Some insurers may require a pre-authorization before the sample is initiated, which may delay the start of the test. We will notify your office if this is the case.

What if I received an Explanation of Benefits (EOB) from my insurance company or my patient’s insurance company stating that the claim was denied?

The EOB is not a bill, but it may show pending payments or even a claim denial by the insurance company. When the insurance company processes a claim, the policyholder is sent an EOB notice. Sometimes the insurance company denies a claim because they want more information such as medical records, which may be information only the healthcare provider’s office can provide. Once additional requested information is obtained, Gulfstream will send it directly to the insurance company, and the patient often does not need to take any action. If there are any questions about the procedures or the charges on the EOB, the patient should contact Gulfstream’s Billing Department.

Why should you choose urine drug analysis?

Urine drug testing has been the preferred biologic specimen or gold standard for determining the presence or absence of most drugs since its inception. This is, in part, due to the increased window of detection of 24 to 72 hours for most drugs and/or their drug metabolites. Since urine specimens have a longer detection window this means that a patient’s usage can be detected for a longer duration of time. Drug metabolites are more frequently found in urine specimens; therefore, a urine drug testing lab can assist physicians in readily determining if their patients are staying compliant with prescribed medications and treatment plans.

How are specimens delivered to the laboratory?

Gulfstream Diagnostics utilizes FedEx® as our courier service of choice. For specimen pick up, please call 800.GOFEDEX or contact your Account Manager.

Why are screening and confirmation cutoff levels different?

Screening and confirmation testing are performed using different methodologies that necessitate different cutoff levels. The cutoff levels of an immunoassay screen are typically higher than those of a more sensitive LC-MS/MS confirmation test, because they screen for a larger group of parent compounds, metabolites and other structurally similar compounds.

When can I expect to see the drug test report?

Urine screening results are typically available within 1 business day of receipt of the specimen. Presumptive positive specimens are usually confirmed (unless they are "Screen Only") within 2 business days, depending on the method.

How long does Gulfstream Diagnostics store the specimen?

Gulfstream Diagnostics stores urine and oral fluid specimens, whether positive or negative, for 60 days, and blood specimens for 7 days.

What is the importance of checking the urine temperature strip on the collection cup?

Under normal conditions fresh urine will display a temperature between 90 and 100 degrees Fahrenheit on the temperature strip, if read within four minutes of the collection. Should the temperature strip not register, the specimen should be immediately re-checked using a new cup (or strip) and the results recorded on the requisition. Specimens with a temperature out of range may indicate a substituted or adulterated specimen.

What is the importance of checking urine creatinine levels?

Creatinine is a metabolic by-product of muscle metabolism, and normally appears in urine in relatively constant quantities over a 24 hour period with "normal" liquid intake. Therefore, urine creatinine can be used as an indicator of urine water content (dilution) or as a marker identifying a specimen as urine. Greater than normal intake of water will increase the urine water content (lowering the creatinine level) consequently diluting any drug which may be present in urine. Conversely, a limited intake of water can lead to an abnormally concentrated urine specimen (as occurs with dehydration) resulting in elevated creatinine levels.

What is the point of doing LC-MS/MS when we’ve already done a urinary point-of-care test?

LC-MS/MS is more sensitive and specific than the urinary point-of-care test. Drugs are separated along size and charge metrics. Both parent drugs and fragmented analytes are identified using the tandem mass spectrometer’s computer. From there, the information may be accessed at any time.

In contrast, point-of-care tests are immunoassays. They can lead to false positives and false negatives, especially in individuals with heterophile antibodies due to severe illnesses or autoimmune diseases. It is possible for those antibodies to impact the ways in which drugs “attach” themselves inside the body. Likewise, HAMA bodies, contracted by rodent bites, may lead to false positives and negatives.

How do my genes affect which medication may work for me?

Your genes may affect the way medications work in your body—some medications could work better with your unique genetic profile and some medicines might not work at all for you. Your genes also can affect how quickly your body breaks down (metabolizes) medicine and gets medicine into your bloodstream.