What is the process for contracting services with PGx Software LLC?

In order to set up an account for your laboratory, we will schedule an interview to determine your PGx laboratory needs.  This discussion will focus on:

Establishing the SNP genotyping that will maximize your PGx report to best serve your patients and determining the most appropriate methodology for your laboratory.

Training so your personnel are able to upload data to PGx Software and obtain reports.

What drugs do PGx Software reports include?

Our reports include 12 major drug categories and over 500 medications.  The included categories are:

  1. Pain Management (Anti-inflammatory, Analgesic, Antipyretic, Opioid, drugs for Gout pain)
  2. Cardiovascular (Antiarrhythmic, Antihypertensive, Cardiac stimulant, Vasodilator, drugs for Angina, Anticoagulant, Antiplatelet, Dyslipidemia)
  3. Internal medicine (Abortifacient, Antihistamine, Dermatology, Diabetes, Gastrointestinal, Hyperparathyroidism, Migraine, Obesity, Respiratory)
  4. Psychiatry (Antidepressant, Antipsychotic)
  5. Neurology (ADHD, Alzheimer’s, Anticonvulsant, Anxiolytic, Epilepsy, Hypnotic, Muscle Relaxant, Parkinson’s & Related Drugs, Sedative)
  6. Infectology (Anthelmintic, Antibiotic, Antifungal, Antimalarial, Antiretroviral, Antiviral)
  7. Oncology, Hematology (Antineoplastic, Targeted Therapy)
  8. Organ Transplantation (Immunomodulation, Immunosuppressive)
  9. Anesthesiology (Anesthetic, Muscle Relaxant)
  10. Urology (Benign Prostatic Hypertrophy, Erectile Dysfunction, Incontinence)
  11. Endocrinology (Androgen, Anti-androgen, Contraceptive, Glucocorticoid, Thyroid)
  12. Recreational Drugs (Alcohol, Barbiturates, Benzodiazepines, Cannabinoids, Dissociative Drugs, Synthetic Cannabis, Tobacco)

How long will it be before our lab personnel will be able to upload samples?

It will take 7-10 business days to fully process your contract and set you up in our system. PGx Software also needs you to provide your company’s: full list of genomic variations (single-nucleotide substitutions-SNPs, copy-number variations-CNVs, variable number tandem repeats-VNTRs), Business address, Logo, Phone, Fax, Website, and name of Laboratory Director.

How many different types of reports does PGx Software typically generate for clients?

In general, three types of reports are created.  However, your laboratory can request customized reports based on the 12 major groups of drug categories listed above.

How should files be formatted for uploading to PGx Software?

Files should be in an Excel-compatible format. PGx provides Excel forms for your use.

How many files can be uploaded at one time?

The software can handle up to 50 patients at a time.

How many different kinds of files can be uploaded at a time?

Up to thirty file formats can be uploaded at a time.  Please reference line 16 of our Excel spreadsheet to see your options on the types of report your company has to choose from.

How long does it take to receive reports?

Once the Excel file has been uploaded to our server, it will take about one business day for the report to become available. Some reports will be available faster.

Which information requested on the form is required in order to avoid an error?

Correct genotyping must be supplied where requested.  This is the most important information. The other required information is:

Accession number: Required as each unique file includes this number.

Report format type: We ask that you use a letter-number combination from F01 to F30. However, you may request larger sets of different reports.

Renal function:  In most cases, you will enter a “1.”  In cases of diminished function, decimals can be used: 0.8 (80% of function), 0.6 (60% of function), 0.4 (40% of function), and 0.2 (20% of function).

Tobacco Use:  Enter a “1” if the patient is a non-smoker; a “2” for smokers.

Daily or nearly daily alcohol intake: Enter a “1” if patient is a male consuming less than 21 alcohol units per week (and no more than 4 units in a given day) or a female consuming less than 14 alcohol units per week (and no more than 3 units in a given day), and having at least 2 alcohol-free days per week.  Enter “2” in the case of higher consumption.

Second report in case of ambiguous haplotype data: Generally, you will enter “1” which means that you do want a second report to be generated in this situation.  Enter “2” if you do not want a second report generated.  If a “2” is entered, only the small activity for NAT2 and CYP2D6 will be reported.

How many reports are generated for each patient?

For most patients, only one very comprehensive report is generated.  In a few cases, involving either the CYP2D6 gene or the NAT2 where the haplotype is undetermined, two reports will be generated. In addition, two more reports can be generated in case the patient is receiving medications or substances known to induce and/or inhibit the metabolism.

Is it required that the Excel files be uploaded in a specific order?

No, once uploading begins, the SNPs are organized by the software–as long as the rs number is correct and entered in the area designated for SNPs and the genotyping is present in the area designated for the genotypes.

Do all the genotypes on the uploaded Excel file require a unique orientation format?

It is recommended that you use the same nomenclature as the forward ORF (open reading frame), but most genotypes do not required the unique orientation format except triallelic SNPs, and A↔T and C↔G SNPs.

Does every single gene that appears in the report include a drug/gene association?

No, sometimes the SNP does not correlate with the phenotype even though there is an association.

How are the findings presented on the patient report?

In the drugs section, a red dot means the drug is/will be toxic to the patient; a green dot means to prescribe the standard drug dose; the yellow dot indicates the patient metabolizes the drug faster than is normal and will therefore require a higher dosage.

For prodrugs such as Codeine, a red dot means the drug is being metabolized faster than is normal and a higher dose will be required; a yellow dot means the drug is toxic (in the case of Codeine, this means the drug is converting to Morphine); a green dot means to prescribe the drug at the standard dosage. When a green dot is not present, the following disclaimer will be included: No patient should evaluate or use the information contained herein without the advice, consultation and supervision of a licensed healthcare professional such as a pharmacist or physician. For current and future medical treatment, it is important that you share this pharmacokinetics report with all your healthcare providers. This information needs to be reviewed any time medication changes are considered so that the safest and most effective drug and dose can be determined for the patient. Always consult with your doctor before you start or stop a medication or change the prescribed dosage.

What happens once the report has been created?

The pdf report will then be ready for you to download. PGx securely backs up and saves each patient report to our HIPAA-compliant platform.

How many languages does PGx Software support?

Our software support fourteen languages including: Arabic, Simplified Chinese, Dutch, English (USA and Canada-Great Britain-Oceania), French, German, Hindi, Italian, Japanese, Korean, Portuguese, and Spanish.