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Genetic Lab Testing Services | PGx Genetic Testing

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  • Genetic Lab Testing Services | PGx Genetic Testing

PHARMACOGENETIC/PHARMACOGENOMICS TESTING

GeneAlign pharmacogenetic technologists provide quality genetic lab testing services and clinically relevant analysis on 19 genes associated with the metabolism, response and interactions of over 180 of the most commonly prescribed medications across multiple physician specialties. With accurate, actionable data on enzyme functions, clinicians can quickly and efficiently select the ideal therapeutic treatments for their patients, potentially reducing efficacy lag-time during medication interventions and lowering the risk of adverse drug events associated with traditional trial and error approaches to prescribing medicine.

We currently have five testing panels for patients taking medications for cardiovascular health, psychiatric health, pain management, pain & psychiatric and comprehensive, with three additional panels in development.

Pain Panel

  • Assists clinicians in the targeted selection of medication used to treat patients with acute and chronic pain.
  • Patients can receive the right medications they need in the optimal doses, providing faster and more efficient symptom relief.
  • Providers can use this testing service before surgery to determine the most efficacious medication for patients in the post-operative period.
  • PGx data on three classes of pain medications: NSAIDS, opioids, and opioid antagonists

Psychiatric Panel

  • Removeds the trial and error approaches for drug selection and dosing have typically been the standard for patients suffering from anxiety, depression, bipolar disorder and other behavioral disorders.
  • Optimizes clinician’s medication selection through PGx-based decision support, reducing the lag-time between medication intervention and optimal therapeutic benefit.
  • Multiple classes of psychiatric medications including antidepressants, antipsychotics, benzodiazepines, norepinephrine reuptake inhibitors, substituted amphetamines and more.

Cardiovascular Panel

  • 17,000 strokes per year could be prevented if dosing guidelines were followed based on genetic tests for the blood thinner warfarin1.
  • In combination with patient-reported adherence questionnaires, physicians can ensure that their patients are getting the treatment they need for better heart health, reducing the likelihood of a life-threatening cardiovascular event.
  • Tests the activity level of enzyme systems involved in the metabolism of cardiovascular medications including antiarrhythmics, anticoagulants, antidiabetics, antihypertensives, platelet aggregation inhibitors, statins, and thrombophilias.

Pain and Psychiatric Panel

  • Assists clinicians in the targeted selection of medication used to treat patients with acute and chronic pain
  • Patients can receive the right medications they need in the optimal doses, providing faster and more efficient symptom relief.
  • Optimizes clinician’s medication selection through PGx-based decision support, reducing the lag-time between medication intervention and optimal therapeutic benefit.
  • Multiple classes of psychiatric medications including antidepressants, antipsychotics, benzodiazepines, norepinephrine reuptake inhibitors, substituted amphetamines and PGx data on three classes of pain medications: NSAIDS, opioids, and opioid antagonists.

Comprehensive Panel

  • We combined our three individual panels (Pain, Psych and Cardio) to form a "Personalize Medicine Panel".
  • In combination with patient-reported adherence questionnaires, physicians can ensure that their patients are getting the treatment they need for better heart health, reducing the likelihood of a life-threatening cardiovascular event.
  • Tests the activity level of enzyme systems involved in the metabolism of cardiovascular medications including antiarrhythmics, anticoagulants, antidiabetics, antihypertensives, platelet aggregation inhibitors, statins, and thrombophilias.

Future Panels and Research

  • Ongoing research and development on the forefront of the field of pharmacogenetics creates an environment where scientific discoveries make available new, innovative technology and testing services. As part of this growing industry, GeneAlign is committed to providing the latest PGx offerings to address the various needs of our customers, improving patient care every step of way.
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PINPOINT CLINICAL PGX TESTING LAB

PinPoint Clinical is our in-house reference lab specializing in PGx testing lab services. Clinicians can send their patients’ DNA samples to our lab for PGx analysis. Our comprehensive genetic tests are one-time tests designed specifically to enhance patient care.


OUR PGx TESTING LAB PROCESS

PinPoint Clinical customers receive the following:

  • Collection kits with pre-paid UPS shipping envelopes
  • Requisition forms with medical necessity
  • Access to instructional videos and documents that facilitate proper sample collection
  • Timely PGx analysis and reporting
  • Comprehensible and actionable paper reports

PinPoint Clinical is located in Chandler, Arizona. PinPoint Clinical is a HIPAA-compliant, Medicare-approved, Clinical Laboratory Improvement Amendment (CLIA) lab.

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PINPOINT PARTNERS

PinPoint Partners provides genetic test consulting and implementation services to hospitals, physicians practices, and reference genetic testing labs seeking to augment the services they provide through pharmacogenomics/pharmacogenetic testing. As personalized medicine becomes an integral part of medical practice, we seek to break through the barriers hindering PGx adoption from meaningful, clinical use by providing a low-risk solution to PGx testing within high-complexity laboratory facilities.


CREATE YOUR OWN PGX TESTING LAB

Our complete turnkey solution implements PGx testing capability into existing physician-owned labs, hospital owned labs, or reference labs including:

  • Lab design, implementation, and validation
  • Installation of all testing equipment
  • All consumables and equipment supplied by our manufacturing partner
  • Customized software platform
  • 28 Standard Operating Procedures
  • PGx Testing Lab Training for technicians
  • Pharmacogenomics/Pharmacogenomics Ongoing support

PHARMACOGENOMICS ONGOING SUPPORT

  • The phenotype of a patient is automatically identified in over 95% of the samples run through the GeneAlign testing process. Once the phenotype is determined, the clinical decision support (CDS) system runs the algorithms and generates the report.
  • For those rare patients whose genetic profile is unclear, GeneAlign genetic technicians remotely review the results and classify the phenotype. This service allows the Company’s clients to hire lab technicians with no previous genetic testing experience.
  • GeneAlign has built inventory management processes into the lab information system (LIS). As the customer draws down its supply of chips and consumables, GeneAlign has the materials delivered to the client lab, ensuring that test orders are processed quickly.
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Point of Care™ PHARMACOGENETIC SOFTWARE

As part of our complete technological solution for PinPoint Partners customers, the Point of Carepharmacogenetic software solution powered by GeneAlign technology facilitates physician workflow by providing actionable genetic data where it is most valuable. Point of Carepharmacogenetic software interprets the results of each patients’ pharmacogenetic test using proprietary, algorithm-based software, and displays the results to the physician with medication management assistance and clinical decision support tools based on pharmacogenetic evidence.

GeneAlign’s Point of Carepharmacogenetic software solution is made-up of several components, all of which are essential to the long-term success of pharmacogenetic test providers. No other company has combined all of these capabilities into an integrated software solution for clinical laboratories.

Features:

Lab Information System (LIS)

  • The LIS system manages the business aspects of the lab processes
  • Test orders are captured in or routed to the LIS. Physicians, orders, patients and their demographic and medication information are managed through the LIS
  • The LIS tracks inventories of chips and lab consumables.

Clinical Decision Support (CDS)

  • The physician-facing component is the CDS, GeneAlign’s reporting tool
  • Reports can be delivered as static PDF files and dynamic reporting is available over a web portal
  • Physicians can adjust medications and regenerate the report to perform what-if analyses related to a treatment plan for a patient
  • Our interactive decision support tool provides clinical guidance when altering medication treatment including changing drugs, dosing, or when to monitor patient response closely

Protocols

  • In order to demonstrate medical necessity (a key to reimbursement), GeneAlign has developed this component to identify patients who are at sufficient risk of serious adverse drug events
  • A patient completes a survey form in the physician’s office and their responses, combined with their demographic profile and medications, informs the physician’s decision to order PGx testing and provides the physician with the necessary documentation for proper reimbursement

Pharmacogenetic Outcomes

  • The ability to gather patient-reported outcomes (direct feedback from the patient on the success or failure of treatment) is a relatively new requirement from public and private payers
  • For providers of PGx testing, having the processes and systems to gather information from patients will be critical to ensuring ongoing reimbursement for these services allowing physicians to track and measure patient progress and treatment efficacy
  • GeneAlign has developed a web-based outcomes survey tool that can be quickly and easily reconfigured to walk patients through the standard survey tools used in different practice areas