“System And Method For Determining The Effectiveness Of Medications Using Genetics” in Patent Application Approval Process (USPTO 20190385747)

2020 JAN 07 (NewsRx) -- By a News Reporter-Staff News Editor at Hospital & Nursing Home Daily -- A patent application by the inventors Todd, Rob (Doylestown, PA); Wrobel, Jerry (Aurora, OH); Pigott, John (Slyvania, OH), filed on June 14, 2019, was made available online on December 19, 2019, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application is assigned to Xact Laboratories LLC (Twinsburg, Ohio, United States).

The following quote was obtained by the news editors from the background information supplied by the inventors: “A person visiting a doctor may present with one or more symptoms. Based on the symptoms presented, test results, or underlying conditions or diseases diagnosed, the person may be prescribed one or more medications by the healthcare provider as part of a treatment program. The medications prescribed may be selected based on the historical effectiveness of such medications for treating the symptoms presented by the person and/or the underlying disease or condition diagnosed by the healthcare provider. Traditionally, the prescription of medications is, at least initially, based on historical effectiveness. Individual prescriptions may be altered through a trial and error process following the initial prescription. For example, alternative medications or dosages may be prescribed where the prescription of a medication causes a side effect or allergic reaction in a patient. Over prescription or dosing of medications may cause side effects. Under prescription or dosing of medications may bring ineffective results or side effects.

“A person’s genetic makeup affects how the person responds to certain medications. For example, a person’s genetic makeup may cause some medications or dosages to be wholly or partially ineffective. Prescription of medications to a person who has a genetic makeup that makes the medication wholly ineffective may waste resources and unnecessarily expose the person to the risk of side effects. Similarly, prescription of medications to a person who has a genetic makeup that makes the medication partially ineffective may result in less that desirable therapeutic effects or require a larger dosage to be effective. In some cases, alternative medications or dosages are available for use with the same, or similar, therapeutic effects.

“For example, without limitation, a blood thinner may be known to reduce the risk of embolisms and may be prescribed to a person following stent placement. However, individual genetic makeup or physiology may alter the effectiveness of the prescribed blood thinner. For example, without limitation, the blood thinner may have a reduced effectiveness in persons carrying specific genetic markers. It would be desirable to substitute alternative medications or adjust the dosage of prescribed medications for persons having a genetic makeup which reduces the effectiveness of the prescribed medication. As a further example, again without limitation, the prescribed blood thinner may be wholly ineffective in persons carrying specific genetic markers. It would be desirable to substitute alternative medications, or find alternative treatment options, for persons having a genetic makeup which renders the prescribed medication ineffective. Therefore, what is needed is a system and method for determining the effectiveness of medications using genetics.

“These disclosures provide a system and method for determining the effectiveness of medications using genetic data. A user’s visit information may be reviewed to identify applicable tests. For example, such tests may indicate the presence or non-presence of genetic markers which may indicate a genetic makeup for a patient that may have a bearing on the effectiveness of one or more medications prescribed, or likely to be prescribed, to the user. The system may determine whether identified tests fits certain billing parameters. For example, the system may be configured to determine whether the identified tests are covered by the user’s insurance. If the test for one or more markers does not fit the billing parameters, then the next genetic marker(s) may be considered. If the test does fit the billing parameters then the option to order testing may be presented to the healthcare provider. If selected, the appropriate marker(s) may be added to a testing device and the genetic testing may be performed.

“To perform the testing, genetic material may be removed from the user. A testing device may be created to test for the specific genetic marker(s) ordered by the healthcare provider. The genetic material may be sequenced using the testing device and the presence or non-presence of the tested genetic markers may be determined. The results may be analyzed and ineffective medications may be identified. In exemplary embodiments, for each medication prescribed or likely to be prescribed, the presence or non-presence of a genetic marker may be compared against the medications known to be effective or ineffective in the presence of the given marker. Effective medications and/or dosages may be flagged. Alternatively, or additionally, ineffective medications and/or dosages may be flagged. For those medications and/or dosages determined to be ineffective, alternative medications, dosages, and/or treatment options may be suggested. Regardless, the testing results may be returned to the healthcare provider’s system. For example, treatment of a particular disease may normally first begin with medication. However, if the person has a genetic makeup which would make such medication ineffective, a surgical option may instead be suggested.

“The results may be returned to the healthcare provider in the form of an interface for display on an electronic display. The results may be displayed in a fashion which provides the clinical consequences of prescribing the medication. The interface may further provide indications of particular conditions and generate alerts when particular conditions are met. For example, without limitation, executable software instructions may be provided which configure the electronic display to display an interface comprising an explanation of the results, alerts, abnormal ranges, ineffective medications, potential interactions as understood in view of the analyzed genetic information, and other clinical information. This information may be transmitted with the results in a single file. In exemplary embodiments, these results and alerts may be integrated into the healthcare providers’ electronic medical record system (EMR) by way of a single file. This information may be further transmitted to any number of healthcare provider facilities, such as but not limited to hospitals, by way of one or more healthcare information exchanges. For example, information may be transmitted to all healthcare providers treating the user. The results may also be stored for use by, and selective transmitted to, future healthcare providers.

“Further features and advantages of the devices and systems disclosed herein, as well as the structure and operation of various aspects of the present disclosure, are described in detail below with reference to the accompanying figures.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “A person visiting a doctor may present with one or more symptoms. Based on the symptoms presented, test results, or underlying conditions or diseases diagnosed, the person may be prescribed one or more medications by the healthcare provider as part of a treatment program. The medications prescribed may be selected based on the historical effectiveness of such medications for treating the symptoms presented by the person and/or the underlying disease or condition diagnosed by the healthcare provider. Traditionally, the prescription of medications is, at least initially, based on historical effectiveness. Individual prescriptions may be altered through a trial and error process following the initial prescription. For example, alternative medications or dosages may be prescribed where the prescription of a medication causes a side effect or allergic reaction in a patient. Over prescription or dosing of medications may cause side effects. Under prescription or dosing of medications may bring ineffective results or side effects.

“A person’s genetic makeup affects how the person responds to certain medications. For example, a person’s genetic makeup may cause some medications or dosages to be wholly or partially ineffective. Prescription of medications to a person who has a genetic makeup that makes the medication wholly ineffective may waste resources and unnecessarily expose the person to the risk of side effects. Similarly, prescription of medications to a person who has a genetic makeup that makes the medication partially ineffective may result in less that desirable therapeutic effects or require a larger dosage to be effective. In some cases, alternative medications or dosages are available for use with the same, or similar, therapeutic effects.

“For example, without limitation, a blood thinner may be known to reduce the risk of embolisms and may be prescribed to a person following stent placement. However, individual genetic makeup or physiology may alter the effectiveness of the prescribed blood thinner. For example, without limitation, the blood thinner may have a reduced effectiveness in persons carrying specific genetic markers. It would be desirable to substitute alternative medications or adjust the dosage of prescribed medications for persons having a genetic makeup which reduces the effectiveness of the prescribed medication. As a further example, again without limitation, the prescribed blood thinner may be wholly ineffective in persons carrying specific genetic markers. It would be desirable to substitute alternative medications, or find alternative treatment options, for persons having a genetic makeup which renders the prescribed medication ineffective. Therefore, what is needed is a system and method for determining the effectiveness of medications using genetics.

“These disclosures provide a system and method for determining the effectiveness of medications using genetic data. A user’s visit information may be reviewed to identify applicable tests. For example, such tests may indicate the presence or non-presence of genetic markers which may indicate a genetic makeup for a patient that may have a bearing on the effectiveness of one or more medications prescribed, or likely to be prescribed, to the user. The system may determine whether identified tests fits certain billing parameters. For example, the system may be configured to determine whether the identified tests are covered by the user’s insurance. If the test for one or more markers does not fit the billing parameters, then the next genetic marker(s) may be considered. If the test does fit the billing parameters then the option to order testing may be presented to the healthcare provider. If selected, the appropriate marker(s) may be added to a testing device and the genetic testing may be performed.

“To perform the testing, genetic material may be removed from the user. A testing device may be created to test for the specific genetic marker(s) ordered by the healthcare provider. The genetic material may be sequenced using the testing device and the presence or non-presence of the tested genetic markers may be determined. The results may be analyzed and ineffective medications may be identified. In exemplary embodiments, for each medication prescribed or likely to be prescribed, the presence or non-presence of a genetic marker may be compared against the medications known to be effective or ineffective in the presence of the given marker. Effective medications and/or dosages may be flagged. Alternatively, or additionally, ineffective medications and/or dosages may be flagged. For those medications and/or dosages determined to be ineffective, alternative medications, dosages, and/or treatment options may be suggested. Regardless, the testing results may be returned to the healthcare provider’s system. For example, treatment of a particular disease may normally first begin with medication. However, if the person has a genetic makeup which would make such medication ineffective, a surgical option may instead be suggested.

“The results may be returned to the healthcare provider in the form of an interface for display on an electronic display. The results may be displayed in a fashion which provides the clinical consequences of prescribing the medication. The interface may further provide indications of particular conditions and generate alerts when particular conditions are met. For example, without limitation, executable software instructions may be provided which configure the electronic display to display an interface comprising an explanation of the results, alerts, abnormal ranges, ineffective medications, potential interactions as understood in view of the analyzed genetic information, and other clinical information. This information may be transmitted with the results in a single file. In exemplary embodiments, these results and alerts may be integrated into the healthcare providers’ electronic medical record system (EMR) by way of a single file. This information may be further transmitted to any number of healthcare provider facilities, such as but not limited to hospitals, by way of one or more healthcare information exchanges. For example, information may be transmitted to all healthcare providers treating the user. The results may also be stored for use by, and selective transmitted to, future healthcare providers.

“Further features and advantages of the devices and systems disclosed herein, as well as the structure and operation of various aspects of the present disclosure, are described in detail below with reference to the accompanying figures.”

The claims supplied by the inventors are:

“1. A system for alerting a healthcare provider to ineffective medications comprising: a healthcare provider system comprising an electronic display and an electronic storage device comprising data regarding medications prescribed by, or likely to be prescribed by, the healthcare provider to each of a number of patients treated by the healthcare provider; a database comprising data regarding medications known to be ineffective in persons having particular genetic markers; and a laboratory system in electronic communication with the healthcare provider system and the database, wherein the laboratory system comprises a processor and an electronic storage device comprising software instructions, which when executed, configure the processor to: receive genetic testing results comprising genetic markers of a patient from said number of patients treated by the healthcare provider; query the database to determine whether any medications in the list of medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient are known to be ineffective in persons having the same genetic markers as the patient; and generate and transmit an alert to the healthcare provider system indicating which of the medications in the list of medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient which are known to be ineffective in persons having the same genetic markers as the patient; wherein said healthcare provider system comprises a processor and executable software instructions stored at the electronic storage device which, when executed, configure the processor to display said alert on said electronic display.

“2. The system of claim 1 wherein: said healthcare provider system comprises an electronic medical record system.

“3. The system of claim 2 wherein: said healthcare provider system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to display a list comprising identifying information for each of said number of patients treated by the healthcare provider; said alert comprises an indicator in association with the patient which indicates whether one or more medications prescribed, or likely to be prescribed, to said patient are known to be ineffective in persons having the same genetic markers as the patient; and said alert is flagged as an allergy in the electronic medical record system.

“4. The system of claim 1 wherein: said healthcare provider system further comprises diagnostic codes and insurance information for each of said number of patients treated by the healthcare provider stored at the electronic storage device; and said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to: receive said diagnostic codes and said insurance information for the patient; determine which genetic tests are covered by the patient’s insurance; and display a prompt at said healthcare provider system to add genetic tests covered by the patient’s insurance to a list of ordered tests.

“5. The system of claim 4 wherein: said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to generate instructions for the automated assembly of a genetic testing device based upon the list of ordered tests.

“6. The system of claim 1 wherein: said database further comprises a list of alternative medications; and said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to display a suggested alternative medication, based on said list of alternative medications, for each medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient which are known to be ineffective in persons having the same genetic markers as the patient.

“7. The system of claim 1 wherein: said healthcare provider system further comprises diagnostic codes for each of said number of patients treated by the healthcare provider stored at the electronic storage device; said database further comprises a list of alternative treatment options; and said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to display a suggested alternative treatment option, based on said list of alternative treatment options, for each condition diagnosed by the healthcare provider which is known to normally require medications which are known to be ineffective in persons having the same genetic markers as the patient.

“8. The system of claim 1 further comprising: a genetic material gathering device; and a genetic sequencing device, wherein said genetic sequencing device is configured to receive the genetic material gathering device, wherein said genetic sequencing device is in electronic communication with said laboratory system.

“9. The system of claim 1 wherein: said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to generate a web-based portal on said healthcare provider device; and said healthcare provider device is a personal electronic device.

“10. The system of claim 1 wherein: said database further comprises diagnostic codes and a list of commonly prescribed medications associated with said diagnostic codes; and said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to: receive diagnostic codes from the healthcare provider system; and query the database to retrieve the commonly prescribed medications associated with the received diagnostic codes to determine the medications likely to be prescribed to the patient.

“11. The system of claim 1 wherein: said healthcare provider system comprises a list of medication prescribed to the user; said database further comprises a list of tests for genetic markers known to affect the efficacy of various medications; and said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to: receive the prescribed medications from the healthcare provider system; query the database to retrieve the tests for genetic markers known to affect the efficacy of the prescribed medications; and transmit a list of the identified tests to the healthcare provider system.

“12. A system for alerting a number of healthcare providers to ineffective medications comprising: a number of electronic medical records systems (“EMRs”), each associated with one or more of a number healthcare practices and each comprising an electronic display and data regarding medications prescribed by one or more healthcare providers of one of the healthcare practices to each of a number of patients treated by the healthcare providers of the healthcare practice; a number of personal electronic device in electronic communication with each of said number of EMRs; a database comprising data regarding medications known to be ineffective in persons having particular genetic markers and a list of alternative medications and treatment options; a healthcare information exchange system in electronic communication with each of the EMRs of each of the number of healthcare practices; a genetic sequencing machine; and a laboratory system in electronic communication with the healthcare information exchange system, the database, and the genetic sequencing machine, wherein the laboratory system comprises a processor and an electronic storage device comprising software instructions, which when executed, configure the processor to; receive genetic testing results from the genetic sequencing machine comprising genetic markers of a particular patient; query the database to determine whether any medications in the list of medication prescribed to the particular patient are known to be ineffective in persons having the same genetic markers as the particular patient (the “ineffective medications”); query the database to determine alternative medications and treatment options for each of the ineffective medications; and generate an alert comprising the ineffective medications, the alternative medications, and the alternative treatment options for each of the ineffective medications; wherein said healthcare information exchange is configured to transmit the alert to each of the EMRs associated with a healthcare practice associated with one or more healthcare providers treating said particular patient; wherein each of said personal electronic devices in communication with the respective EMR receiving said alert are configured to display said alert in a web-based portal on the respective electronic display; wherein said alerts are configured to be displayed in the allergy portion of the EMRs.

“13. The system of claim 12 wherein: each of said personal electronic devices are configured to display, in the web-based portal, a list comprising identifying information for each of said number of patients scheduled to be seen by the respective healthcare provider on a given day; and each of said EMRs comprise software instructions stored at an electronic storage device, which when executed, configure a processor to display all received alerts in the form of an indicator, in the web-based portal, and in association with the particular patient for whom an alert was received which indicates that one or more medications are prescribed to said particular patient which are known to be ineffective in persons having the same genetic markers as the particular patient.

“14. The system of claim 12 wherein: each of said EMRs comprises diagnostic codes and insurance information for each of said number of patients treated by the healthcare provider; said laboratory system comprises additional software instructions stored at the electronic storage device, which when executed, configure the processor to: receive said diagnostic codes and said insurance information for the particular patient; determine which genetic tests are covered by the particular patient’s insurance and meet medically necessary criteria; and automatically order the covered genetic tests.

“15. A method for alerting a healthcare provider to ineffective medications comprising: providing, at a healthcare provider system, a list of medications prescribed by, or likely to be prescribed by, a healthcare provider to each of a number of patients treated by the healthcare provider; providing a database comprising data regarding medications known to be ineffective in persons having particular genetic markers; providing a healthcare information exchange in electronic communication with a number of healthcare provider systems, including the healthcare provider system; receiving, at a laboratory system, genetic testing results comprising genetic markers of a patient from said number of patients treated by the healthcare provider; transmitting, from the laboratory system to the healthcare information exchange, data regarding the genetic testing results; querying the database to determine whether any medications in the list of medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient are known to be ineffective in persons having the same genetic markers as the patient; generating an alert for display at the healthcare provider system indicating which, if any, of the medications in the list of medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient are known to be ineffective in persons having the same genetic markers as the patient; and displaying, at an electronic display associated with the healthcare provider system, the alert.

“16. The method of claim 15 further comprising the steps of: providing, at the healthcare provider system, diagnostic codes and insurance information for the patient; determining which genetic tests are covered by the patient’s insurance; automatically adding, at the healthcare provider system, the genetic tests covered by the patient’s insurance to a list of ordered tests; and transmitting the lists of ordered tests to the laboratory system.

“17. The method of claim 15 further comprising the steps of: providing, at the healthcare provider system, diagnostic codes for the patient; providing, at the database, a list of commonly prescribed medications associated with diagnostic codes; and querying the database to retrieve the commonly prescribed medications associated with the received diagnostic codes to determine the medications likely to be prescribed to the patient.

“18. The method of claim 15 further comprising the steps of: providing, at the database, a list of alternative medications; querying the database to retrieve one or more alternative medications for each medication prescribed by, or likely to be prescribed by, the healthcare provider to the patient which are known to be ineffective in persons having the same genetic markers as the patient; and transmitting said one or more alternative medications to the healthcare provider system for display.

“19. The method of claim 15 wherein: said laboratory system is configured to generate displays at said healthcare provider system by way of a web-based portal; said healthcare provider system comprises an electronic medical record; said laboratory system is configured to automatically update said electronic medical record with said genetic testing results and alerts; and said alerts are flagged as an allergy in the electronic medical record.

“20. The method of claim 15 further comprising the steps of: providing, at the healthcare provider system, medications prescribed to the patient; providing, at the database, a list of tests for genetic markers which are known to affect the efficacy various medications; querying the database to retrieve tests applicable to the medications prescribed to the patient; and providing, by way of the healthcare provider system, a prompt for the healthcare provider to order said identified tests.”

URL and more information on this patent application, see: Todd, Rob; Wrobel, Jerry; Pigott, John. System And Method For Determining The Effectiveness Of Medications Using Genetics. Filed June 14, 2019 and posted December 19, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190385747%22.PGNR.&OS=DN/20190385747&RS=DN/20190385747

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