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Frequently Asked
Questions

General FAQ’s

How does PGx testing benefit the physician?

Improve & revolutionize patient care though PGx testing, Actionable data at the point of care, Tools to follow medical necessity protocols and track outcomes, Incorporating personalized medicine techniques is a competitive advantage, Provides ancillary revenue source for your practice (Precision Genetics LCS Model)

How does PGx testing benefit the patient?

Not everyone responds to a drug or medication in the same way, each individual has their own unique genetic makeup, which affects the way their bodies respond to a disease and treatment. PGx uses information about a person’s genetic makeup to choose the drugs and drug doses that are likely to work best for that person as well as determining the proper drug-to-drug combinations

How much lab space is needed?

Standard rule of thumb is a minimum of 300 sq. ft. and 26’ of countertop space.

How many technicians are required?

Number of technicians depends on the number of samples being run day-to-day. One of the value propositions of the LCS model is that we calculate how much staff you will need (accessions, technicians, directors, etc.) to process your anticipated volumes, provide standard operating procedures and default processing schedules, and provide on site training to get your team up to speed.

Do the technicians require molecular training?

No. They do require experience in pipetting.

Is a medical director required when implementing a PGx lab?

It depends if the existing highly complex CLIA lab has a medical director. Rule of thumb is that a medical director is needed for both urine toxicology screening as well as molecular testing. Commonly a PHD or Pathologist that has a minimum of 2 years experience in running a highly complex lab.

What is the estimated turnaround time to implement and validate the PGx lab?

Lab setup and configuration is a phased process:

  • 4 weeks to secure all ancillary and capital equipment
  • 2 week to train on the LifeTech equipment
  • 2 weeks to validate the genetic testing and train the technicians/staff

Precision Employee Care Solution FAQ’s

What is pharmacogenomics?

Pharmacogenomics is the study of how genes affect a person’s response to drugs. Not every person responds the same way to the same drug. Understanding what role gene cs plays in the efficacy of a drug is how pharmacogenomics fits into this program.

What is precision medicine?

Precision medicine is the practice of taking the entire person into account when assessing one’s health. This is based on many factors, including genetics, diet, exercise, family history, current medications, and the environment. Precision Medicine tailors your treatment based on your genetic profile, clinical conditions, medications, and lifestyle. Precision medicine focuses on prevention by slowing or stopping the progression of disease, predicting adverse response to medications, and even death.

How does this test work?

This test identifies changes in your DNA that are known to affect your response to certain medications. It provides information on whether a drug will work well for you based on your genetics, or whether it may elicit a harmful side-effect. This test also offers a more complete picture of the possible effects of taking all your medications by considering the interaction(s) between drugs and certain lifestyle factors that may be relevant to you, such as smoking.

How is my data kept secure?

Precision Genetics is a HIPAA-compliant company and follows all rules surrounding patient privacy laws. Many technologically prudent actions are taken to keep your data secure. Any personal health information (PHI) is kept private and is not shared with any outside party other than your physician or anyone else you expressly identify. Also, your information will not be shared with your company.

How long until I receive my results?

When we receive your buccal sample, it typically takes about 3-5 days to process and analyze your DNA. After that, your results will be forwarded to the pharmacist to review your current medications and potential changes. This can take about 1-2 weeks to finalize with you and your doctor. Overall, the entire process should take less than 4 weeks.

Why will I talk to a pharmacist?

PG has a team of specialized pharmacists who help you understand their prescription medications through identifying potential drug interactions, adverse effects, lower-cost alternatives, and general medication information. Pharmacists are experts in the field of prescription medication, adverse reactions and how lifestyle plays a factor in medicine usage. Additionally, our pharmacists are trained in understanding the effect that genes have on the metabolism of certain drugs. When considered together, these factors allow the pharmacist to make a recommendation to your doctor regarding the safety and use of your medications.

Who is Precision Genetics?

PG is a recognized service laboratory in the field of pharmacogenomics for its unique genomic solutions and technology platform. We have developed a program to help you, your physicians and pharmacists optimize your prescription on drug therapy in a safe, efficient, and cost-effective manner.

Will this test give me information about my ancestry?

No, this DNA test will not report any ancestry information. This DNA test will only provide information about how your genes affect your response to specific medications.

Will this test tell me if I am going to get cancer?

No, this DNA test will not be used to determine your likelihood of developing any diseases. This DNA test will only provide information about how your genes affect how you respond to specific medications.

How can this test save me money?

This test will shed light on the medication you are taking that may not be working properly for you. This test may determine that an alternative drug therapy is better suited for you, which may cost less. However, there may be times that the appropriately recommended drug therapy could be more costly.

Why do you need my email address?

Your email address may be used to ask about your experience with this new benefit and the enrollment process. We will not use your email address for any sales or other marketing messaging. We will not provide your email address to anyone/third party companies outside of the Employee Care program.

Can my spouse participate?

This benefit is for participants in your company’s healthcare benefits package and their dependents. Please contact your company’s healthcare benefits provider to understand if you are eligible for coverage under the program. If you are not covered and wish to participate, please contact Precision Genetics for more information.

Why is my company sponsoring this new benefit?

Your company is committed to providing you with the very best health care available. Today, that means taking a “Precision Medicine” approach to tailoring your treatment to your unique DNA, conditions, medications, and lifestyle. Many private insurance plans choose not to cover certain genetic tests since they focus on prevention in addition to treatment. Having this benefit available to those who need it saves money for both the company and for the employee participating in the healthcare benefits of the company. Additionally, this new benefit will empower you and your doctors with genetic information that may improve which medications you are prescribed. These results may reduce adverse drug reactions and unnecessary side effects and improve how you feel every day.

Will this test cost me money?

If there is a cost to you, your company’s benefits manager would have let you know. You would have received a company communication regarding how the benefit will be covered. However, the information obtained from the test could result in a different drug therapy recommendation which could be more costly if approved by you and your doctor.

Precision Perioperative Medication Risk Solution FAQ’s

What is a Perioperative pharmacogenomics (PGx) test?

This is a genetic test that provides surgeons and anesthesiologists with a profile of their patient’s ability to metabolize different medications that are used before, during, and after surgery. The results of this unique individual genetic profile are delivered directly to the hospital systems EMR via HIPAA secure connections so the doctors can review the results and proactively plan for a successful surgery and recovery.

How is the testing performed?

A simple cheek swab is collected in order to obtain the DNA necessary to perform the genetic test. This sample must be taken at least 2 weeks prior to surgery in order to have the resulting information back to the doctor before the scheduled surgery. The swab can be collected in the medical office, clinic, or at your home.

What genes are included in this test?

The comprehensive peri-operative test includes a total of 23 genes.

● Peri-operative – 10 genes

● MH – 3 genes

● Opioid assessment – 14 genes

● Other markers – 5 genes

Please refer to the introductory slide deck that was emailed after your introductory call with Precision Genetics for a full list of the genes evaluated.

Are the genes used in the perioperative test validated and useful?

The laboratory at Precision Genetics performed a complete analytical validation of the genes according to CLIA guidelines. These guidelines outline the necessary validation procedures required for laboratories to perform clinical tests on patients. Published papers on the individual genes exist to show the strength between the gene and drug association and includes both the evidence supporting statistical significance and reproducibility of results, as well as the predictive value of the test. These publications often demonstrate the clinical utility which refers to whether the test results impact prescribing action (drug avoidance or dosing change).

How do I order a test?

Part of our onboarding is to set up a way for your practitioners to order the test electronically. When we onboard your health system, we securely connect to your EMR at no cost so that you can both order the test and receive the results in your system. Each step of our process includes training so that all staff members are comfortable with ordering and reading the reports.

Who will pay for the test?

Precision Genetics will bill the insurance provider.

Will this be integrated with my EMR?

Yes. The entire process will be integrated with your EMR. At launch, you will be able to order tests and get reports back. We will then work with you to roll out additional functionality like alerting and disparate genetic data, based on your specific needs. Precision Genetics has a dedicated integration team that is able to work with any EMR vendor. We can also partner with third parties like Redox if that’s what you prefer.

Will your product support our research efforts?

Yes. Our solution is built to enable research. We can record patient and procedure data prior to surgery, and allow your team to input clinical outcomes into our system post-op via our research portal. Thanks to our integration with your EMR, we can automate most of the data collection and input for you. Since every research project is unique, prior to launch we will work with you to define your goals and the data you’d like to capture.

All of our patient information is stored in our EMR. How does that work with this test?

Precision works with different EMRs to integrate our technology with your healthcare’s electronic record system. We have a team of engineers and technology specialists that work with your IT and engineers to ensure a seamless integration at no cost to the hospital. The integration allows you to order and receive results through your system so that your workflow is not interrupted by this new solution.

What information do you have to support your test?

The information we have on how the medications interact with a person’s genetics are found in many published, peer-reviewed papers, as well as consensus guidelines from various professional organizations, such as CPIC and the Dutch Pharmacogenetics Working Group. Other information is directly obtained from FDA labels. We have copies of these papers that we can share with you. We also can present to leaders in your health system on what evidence exists for the different genes and medications associated with surgery.

I want to know more about how the gene pathways are working with my surgical medications.

We encourage you to speak with our clinicians and geneticists for detailed information on the Cytochrome P450 pathways and the different medications used in surgeries that utilize these pathways. Precision focuses on providing guidance on how these medications will work based on your patient’s genetics and our clinicians and pharmacists are there to guide you through the report and interpretations.

What genes test for MH and Thrombosis risk?

Precision evaluates thrombosis risk by specifically looking at the FV Leiden and F2 (Prothrombin) test for thrombosis (VTE) risk, however other genes non-genetic factors are looked at to determine additional risk. The RYR1 and CACNA1S genes test for malignant hyperthermia (MH) risk.

Can we have customized alerts on the reports to other specific genes?

Yes. Precision Genetics is a technology company that can integrate with your system to input that discrete information as well as have the report modified to alert your practitioners to specific gene information.

Will your report help us to determine what opioids a patient can metabolize to help practitioners with prescribing?

Yes, our report will have information regarding genes that metabolize opioids as well as non-opioid pain medications. You will have access to the PDF or printed copy of the report as well as unlimited access to our live, online application, PGLive, which displays the information needed to help you determine what medication regimen to choose for your patient.

Can we add additional genes to the panel if needed?

We can add genes that are of interest to your organization. Precision Genetics’ laboratory scientists will need time to validate the assay prior to the release of the information. Additionally, as clinical research is published and professional guidelines are revised, we will iteratively make changes to the panel. We anticipate that this will be on a semi-annual or annual basis based upon the number and nature of the clinical evidence.

Have Questions About Us?

Our personalized approach to what we do extends beyond our genetics lab.  We, the team, are committed to providing patients, providers, and other labs the quality services and results we put our name behind.