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Frequently Asked Questions

These are our frequently asked questions. For questions not answered here, please contact us at clientservices@pathway.com.


Pathway Genomics Hereditary Cancer Hereditary Cancer

How does cancer develop?

Cancer develops due to an accumulation of damaging DNA changes (mutations) in a single cell over an individual’s lifetime. Most of these changes happen as part of the natural aging process that our bodies go through over time (called somatic changes), while in rare instances some individuals are born with a mutation in all of their cells (called germline changes), which gives them a “head-start” to developing cancer in their lifetime.

What is hereditary cancer?

There are three categories of cancer: (1) Sporadic, (2) Familial/Multifactorial, and (3) Hereditary.
(1)Sporadic cancer is generally thought to be due a combination of environmental factors and natural aging process.
(2)Familial/Multifactorial cancer generally refers to a history of cancer in families that cannot be attributed to a single gene mutation. Development of cancer in these families is likely due to a combination of mutations in multiple low risk or moderate risk cancer genes as well as environmental factors.
(3)Hereditary cancer refers to cancer that is due to a single gene mutation that significantly increases an individual’s risk of certain cancers over their lifetime. Individuals are born with these singe gene mutations, and in most cases, they have been passed down from family members (inherited )for a number of generations.

What is DNA?

Our bodies are made of trillions of cells. Inside each of those cells are chromosomes. In humans, we have 23 pairs of chromosomes. One chromosome of each pair comes from our mother (egg) and the other chromosome comes from our father (sperm). Each chromosome is composed of deoxyribonucleic acid (DNA). A simple analogy is that a person’s DNA serves as a blueprint for all of the information that makes us who we are. The DNA itself is organized into specific segments called genes, which encode proteins needed for our bodies to grow and function. The specific coding within the genes is composed through the use of only four specific DNA bases: A, T, G, and C.

Are all changes in DNA disease-causing?

No, some changes in DNA are normal variations between humans, which do not cause disease. These types of changes are called benign variants. Alternatively, some changes in the DNA can lead to damaged or faulty genes, which in turn can disrupt the function of the proteins normally encoded by the DNA. These changes are called deleterious or pathogenic mutations.

How is hereditary cancer testing ordered at Pathway?

Once it is determined that a patient meets testing criteria for a hereditary cancer syndrome, the genetic counselor or doctor will order testing and send a sample from the patient to the lab. Typically it will be a blood or saliva sample. This process of testing takes about 2-3 weeks and results will be sent to the ordering provider.

Who should get tested?

Individuals should consider genetic testing for hereditary cancer if they have a personal and/or strong family history of certain types of cancer. Cancer diagnoses at a young age as well as rare cancer diagnoses are also indications for testing. The National Comprehensive Cancer Network has established guidelines for who should consider genetic testing. Please speak with your physician for more information or contact one of our genetic counselors at counselors@pathway.com

Will hereditary cancer testing tell me if I have cancer?

No, this type of testing cannot diagnose cancer or tell you if you will definitely develop cancer in the future. However, this test may provide valuable information on your risk to develop certain types of cancer. This information can be valuable for risk reduction and early detection, both of which are very important in fighting and/or preventing cancer.

What does a positive result mean?

A positive result means that a change in the gene, called a mutation, was found that very likely explains an individual’s personal and/or family cancer history. Some genes have specific management guidelines already established to follow for patients that are found to carry a mutation; the guidelines may include increased surveillance, and risk-reducing surgical options and/or medications. Other genes require the consideration of family history in combination with other factors to create a specialized follow-up plan made with the assistance of a physician or genetic counselor. Genetic counselors are also available to review test results and help patients understand the implications of their findings. To find a genetic counselor near you go to www.nsgc.org. Support groups are another great resources for coping with the hereditary cancer diagnosis.

What does a negative result mean?

A negative test result means that there was no mutation or variant detected in the genes tested. There are multiple reasons why this might occur.
True negative. Patient has not inherited the known mutation that was previously found in a family member. This person would have cancer risks similar to the general population.
Uninformative negative. The cause of cancer in the patient and/or family cannot be explained by this genetic test and result. This result is uninformative because it does not identify the cause of the cancer in the family. A chance remains that there is a mutation/variant in the family that was not tested for in the selected testing, or that cannot be detected by current technologies. Without identifying the cause of cancer in the family, we are not able to estimate potential future cancer risks beyond what is seen in the family history.

What does a VUS result mean?

VUS stands for Variant of Uncertain Significance. This result is reported when a change is found in the patient’s DNA, but it is unclear if the change is associated with an increased risk of cancer, or rather is just a benign change not related to an increased risk of cancer. PhD-level scientists at Pathway search databases and published literature to try to understand what this “variant” means for the patient and the patient’s family.

What is Pathway’s Familial Studies Program?

The Familial Studies Program offers family testing, free of charge, to individuals who receive a VUS or Likely Pathogenic test result. Additional family members may be tested to see if they carry the variant, in hopes of providing additional information about its potential pathogenicity. The ultimate goal is to reclassify the variant as either deleterious or benign, although in many instances this may not be possible immediately through a single family study. Patients will work with the genetic counseling team at Pathway to determine the most appropriate family members to test.

Who should I share my results with?

It is important that you share genetic test results with family members. Cancer genetic testing at Pathway tests for mutations in genes that are inherited, meaning they are passed on from generation to generation in a family. If a mutation or a VUS is found, it is important that all first-degree relatives (parents, siblings, children) are notified of the result so that they can discuss testing with their physician or genetic counselor. Most genes associated with hereditary cancer are dominantly inherited, meaning that a mutation in only one copy of the gene is sufficient to increase the risk for cancer. Each first degree relative would have a 50% chance of also testing positive.
Negative results can also be informative for family members; it is important to share results of any genetic testing with your family members.

Will genetic testing affect my insurance coverage?

In 2008, the Genetic Information Nondiscrimination Act was put in place to protect individuals, who undergo genetic testing, from discrimination by insurance companies and employers. The act applies to health insurance, but does not apply to life, disability, or long-term care insurance. Although this act protects most individuals, those who work for small companies as well as military personnel may not be protected. Please visit www.genome.gov/10002328 for more information.

How can I find a genetic counselor?

Most genetic counselors in the United States are listed on www.nsgc.org in the search function on the home page. Pathway’s genetic counseling team is also available to help locate genetic counselors near you; please email counselors@pathway.com.

Pathway Genomics PathwayFit® PathwayFit®

What is a DNA?

Our bodies are made of trillions of cells. Inside each of those cells are chromosomes, and humans have 23 pairs of chromosomes. One chromosome of each pair comes from the mother (egg) and the other chromosome comes from the father (sperm). Each chromosome is composed of deoxyribonucleic acid (DNA). A simple analogy is that a person’s DNA serves as a blueprint for all of the information that makes us who we are. The DNA itself is organized into specific segments called genes, which encode proteins needed for the body to grow and function. The specific coding within the genes is composed through the use of only four specific DNA bases: A, T, G, and C.

Are all changes in DNA disease-causing?

No, some changes in DNA are normal variations between humans, which do not cause disease. These types of changes are called benign variants. Alternatively, some changes in the DNA can lead to damaged or faulty genes, which in turn can disrupt the function of the proteins normally encoded by the DNA. These changes are called deleterious or pathogenic mutations.

How accurate are Pathway's personal genetic reports?

Pathway’s genetic reports are accurate. Pathway Genomics’ laboratory is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S Health and Human Services’ Clinical Laboratory Improvement Amendments (CLIA), and licensed by the California Department of Public Health, thereby assuring you of high quality results.

Unlike other laboratories that outsource the actual performance of the laboratory tests and only handle the interpretations and the reporting of the results, we handle the testing, interpretation and reporting from beginning to end. This allows Pathway better control over the research, testing, pricing and security.

Am I required to notify anyone about my genetic report results?

No, your genetic report is your own personal information. You are not required by law to notify or share this information with anyone. You may find it beneficial to share this information with your doctor or with other family members, but this decision is completely up to you.

Will genetic testing affect my insurance coverage?

To protect individuals who undergo genetic testing from discrimination by insurance companies and employers, the Genetic Information Nondiscrimination Act (GINA) was established in 2008. The act applies to health insurance, but does not apply to life, disability, or long-term care insurance. Although this act protects most individuals, those who work for small companies as well as military personnel may not be protected.
Please visit www.genome.gov/10002328 for more information.

Are Pathway's personal genetic reports covered under my health insurance?

Although some health insurance companies may cover this type of service, the exact policies and what they cover vary greatly. You should contact your own health insurance company to find out if your policy covers Pathway’s genetic testing services.

What is PathwayFit®?

PathwayFit® is a genetic nutrition and exercise profile that tells you how you may react to specific types of food and exercise, and provides insights into how your body may process sugars, fats, nutrients and vitamins. Pathway provides a personalized report that has powerful information and recommendations – all aimed at helping you optimize your health.

How can the PathwayFit® test help me with my weight issues?

The PathwayFit® report provides you with data that may help you lose weight or maintain weight loss. With actionable recommendations included with your results, and pre and post test access to our genetic counselors and dietitians, you will have a foundation for change, as opposed to traditional lab results that don’t provide you with any next steps.

How can the PathwayFit® test help me better plan my diet?

The PathwayFit® test recommends a diet type that is based on your genetic makeup. In addition to the report, Pathway provides complimentary diet plans specifically dependent on a patient’s genetic profile to assist in weight management. The diet plans were written by registered dietitians. Consultations with a registered dietitian are also available free of charge to discuss the recommended diet plan.

Where can I find more information about the PathwayFit® test?

Please visit PathwayFit® for more information about the test, or email one of our genetic counselors at GC@pathway.com or call (877) 505-7374, and select option 4.

How can I take this test? What is the process?

PathwayFit® can be ordered by a prescribing clinician, please request your clinician to contact our customer support team by calling toll free at (877) 505-7374 or by email at clientservices@pathway.com. You can choose to provide either a saliva sample by simply spitting in the saliva collection tube or provide a blood sample with the help of your clinician. After your clinician fills out the paperwork and ships the sample collection kit back to our laboratory, your sample will be processed. When your PathwayFit® report is ready, it will be reviewed by our medical director and then made available to your clinician.

How long will it take to get back my report?

Your clinician should receive your report within two weeks from the date your sample was received by our laboratory.

Can I view my report on my mobile device?

Pathway Genomics now has a patient app that allows existing patients to view their genetic results on mobile devices, such as smart phone and tablets. Our new patient
app allows existing and new customers to import the results of the genetic tests ordered by their physician within minutes. Available on both the iOS and Android mobile operating systems, and available via the Apple Store and Google Play, Pathway’s patient app contains a number of different features and functions for retrieving and viewing actionable genetic testing results.

What do you do with my sample after testing is complete?

After the genetic testing is complete, your saliva or blood sample is destroyed after sixty (60) days by incineration in a secure manner to protect your privacy. Any of your DNA that we have extracted from your saliva that has not been used for testing is stored in our DNA Lockbox™. We keep your DNA extract for the retention time required by federal and state regulations and in accordance with Pathway’s standard operating procedures.

How secure is my personal information?

We encrypt data at rest and in motion. Access to your personal information is controlled by role-based access controls that were built around the HIPAA “Minimum Necessary” rule. That is, when using or sharing data with authorized personnel, we only transmit what is required for the recipient rather than giving them access to all of the data. In addition to encryption and access controls, we log all access “who did what” and keep these logs at an MSSP (Managed Security Services Provider) for real-time analysis.

Pathway Genomics Mental Health DNA Insight® Mental Health DNA Insight®

What is the Mental Health DNA Insight® test?

The Mental Health DNA Insight® test is a genetic test developed by the laboratory of Pathway Genomics. The test looks at genes that play an important role in how your body ‘responds and reacts’ to certain medications. The test identifies potential differences in certain target regions of your DNA that process certain medications. The report highlights such differences and provides actionable recommendations to help your clinician prescribe medications that take into consideration specific differences within your DNA. This test will help your clinician predict how you will respond to more than 50 common antidepressant, mood stabilizers and antipsychotic medications listed in Table 1.

 

Table 1

SSRI Antidepressants

Citalopram
Escitalopram
Fluoxetine
Fluvoxamine
Paroxetine
Sertraline
Vilazodone

SNRI Antidepressants

Duloxetine
Levomilnacipran
Venlafaxine

TCA Antidepressants

Amitriptyline
Clomipramine
Desipramine
Doxepin
Imipramine
Nortriptyline
Protriptyline
Trimipramine

Other Antidepressants

Bupropion
Buspirone
Mirtazapine
Nefazodone
Trazodone
Vortioxetine

Mood Stabilizers

Carbamazepine
Divalproex
Lamotrigine
Oxcarbazepine
Phenytoin
Valproic acid

Benzodiazepines

Clobazam
Diazepam
Alprazolan

ADHD Medication
(NE Reuptake Inhibitor)

Atomoxetine

Typical Antipsychotics

Haloperidol
Perphenazine
Pimozide
Thioridazine
Zuclopenthixol

Atypical Antipsychotics

Aripiprazole
Asenapine
Clozapine
Iloperidone
Lurasidone
Olanzapine
Paliperidone
Quetiapine
Risperidone
Ziprasidone

Others

Dextromethorphan and Quinidine
Galantamine
Modafinil
Tetrabenazine


What medications are included in the Mental Health DNA Insight® test?

Commonly prescribed antidepressants, antipsychotics and mood stabilizers that are FDA approved are reported under Mental Health DNA Insight® test.  For a complete list of reported medications please refer to Table 1.

 

Table 1

SSRI Antidepressants

Citalopram
Escitalopram
Fluoxetine
Fluvoxamine
Paroxetine
Sertraline
Vilazodone

SNRI Antidepressants

Duloxetine
Levomilnacipran
Venlafaxine

TCA Antidepressants

Amitriptyline
Clomipramine
Desipramine
Doxepin
Imipramine
Nortriptyline
Protriptyline
Trimipramine

Other Antidepressants

Bupropion
Buspirone
Mirtazapine
Nefazodone
Trazodone
Vortioxetine

Mood Stabilizers

Carbamazepine
Divalproex
Lamotrigine
Oxcarbazepine
Phenytoin
Valproic acid

Benzodiazepines

Clobazam
Diazepam
Alprazolan

ADHD Medication
(NE Reuptake Inhibitor)

Atomoxetine

Typical Antipsychotics

Haloperidol
Perphenazine
Pimozide
Thioridazine
Zuclopenthixol

Atypical Antipsychotics

Aripiprazole
Asenapine
Clozapine
Iloperidone
Lurasidone
Olanzapine
Paliperidone
Quetiapine
Risperidone
Ziprasidone

Others

Dextromethorphan and Quinidine
Galantamine
Modafinil
Tetrabenazine


What might taking this test mean for me?

Until recently, drugs have been developed with a concept of “one size fits all”. This concept is based on the belief that each medication works the same way in every individual. Research shows that medication response varies greatly from person-to-person, even when the same drug is used with the exact same dose. These person-to-person differences in drug response are largely attributed to specific differences in DNA. Specific information about your DNA can help clinicians prescribe medications that can reduce the chances of treatment failure while reducing the risk of adverse effects.

How can I take this test? What is the process?

The Mental Health DNA Insight® test can be ordered only by a prescribing clinician. If you are interested in how personalized medicine can play a role in your healthcare please request your clinician to contact our customer support team by calling toll free at (877) 505-7373 or by email: clientservices@pathway.com.
You can choose to provide either a saliva sample by simply spitting in the saliva collection tube or provide a blood sample with the help of your clinician. After your clinician fills out the paperwork and ships the sample collection kit back to our CLIA and CAP accredited laboratory, your sample will be processed. When your Mental Health DNA Insight® report is ready, it will be reviewed by our medical director and then made available to your clinician.

How long will it take to get back my report?

Your clinician should get back your report within two weeks from the date your sample was received by our laboratory.

Where can I find more information about Mental Health DNA Insight® test?

Please visit Mental Health DNA Insight® for more information about the test or email one of our genetic counselors at GC@pathway.com.

Pathway Genomics Pain Medication DNA Insight® Pain Medication DNA Insight®

What is Pain Medication DNA Insight® test?

The Pain Medication DNA Insight® test is a genetic test developed by the laboratory of Pathway Genomics. The test looks at genes that play an important role in how your body responds and reacts to certain medications. The test identifies potential differences in select target regions of your DNA that process certain medications. The report highlights such differences and provides actionable recommendations to help your clinician prescribe medications that take into consideration specific differences within your DNA. This test will help your clinician predict how you will respond to commonly prescribed pain medications listed in Table 1.

 

Table 1
Pharmacogenetic Phenotypes Tested
Carisoprodol
Celecoxib
Codeine
Diclofenac
Fentanyl
Flurbiprofen
Hydrocodone

Ibuprofen
Meloxicam
Methadone
Methotrexate toxicity
Oxycodone
Tramadol


What Medications are included in the Pain Medication DNA Insight® test?

Commonly prescribed paid medications that are FDA approved are reported under Pain Medication DNA Insight® test. For a complete list of reported medications please refer to table 1.

 

Table 1
Pharmacogenetic Phenotypes Tested
Carisoprodol
Celecoxib
Codeine
Diclofenac
Fentanyl
Flurbiprofen
Hydrocodone

Ibuprofen
Meloxicam
Methadone
Methotrexate toxicity
Oxycodone
Tramadol


What might taking this test mean for me?

Until recently, drugs have been developed with a concept of “one size fits all”. This concept is based on the belief that each medication works the same way in every individual. Research shows that medication response varies greatly from person-to-person, even when the same drug is used with the exact same dose. These person-to-person differences in drug response are largely attributed to specific differences in DNA. Specific information about your DNA can help clinicians prescribe medications that can reduce the chances of treatment failure while reducing the risk of adverse effects.

How can I take this test? What is the process?

The Pain Medication DNA Insight® test can be ordered only by a prescribing clinician. If you are interested in how personalized medicine can play a role in your healthcare please request your clinician to contact our customer support team by calling toll free at (877) 505-7373 or by email: clientservices@pathway.com.
You can choose to provide either a saliva sample by simply spitting in the saliva collection tube or provide a blood sample with the help of your clinician. After your clinician fills out the paperwork and ships the sample collection kit back to our CLIA and CAP accredited laboratory, your sample will be processed. When your Pain Medication DNA Insight® report is ready, it will be reviewed by our medical director and then made available to your clinician.

How long will it take to get back my report?

Your clinician should get back your report within two weeks from the date your sample was received by our laboratory.

Where can I find more information about Pain Medication DNA Insight® test?

Please visit Pain Medication DNA Insight® for more information about the test or email one of our genetic counselors at GC@pathway.com.

Pathway Genomics Liquid Biopsy Liquid Biopsy

CancerIntercept™ Detect

What is a liquid biopsy?

Both normal and tumor cells release small DNA fragments into the bloodstream; this circulating DNA is known as cell free DNA (cfDNA). A liquid biopsy is a non-invasive, highly-sensitive, and cost-effective method for isolating and detecting cfDNA, including circulating tumor DNA (ctDNA) in the blood of patients with cancer or individuals at risk for contracting cancer.

What is ctDNA?

As a tumor grows, it naturally sheds cells due to cell death (necrosis and/or apoptosis) of the solid tumor tissue. These cells then rupture and release DNA fragments into the bloodstream. This circulating tumor DNA, or ctDNA, can be detected and analyzed by Pathway Genomics’ CancerIntercept™ liquid biopsy test.

Who should be tested with CancerIntercept™ Detect?

CancerIntercept™ Detect is appropriate for individuals who have not been diagnosed with cancer, but have been identified to be at an increased risk of one or more specific cancer types, including: colorectal, breast, lung, and ovarian cancers, melanoma and possibly other cancer types. An individual may be at an increased risk for cancer for a number of reasons, including, but not limited to:
  • Known predisposition to a hereditary cancer syndrome
    e.g. Carrier of a BRCA1 pathogenic variant
  • Family history of cancer
    e.g. Mother diagnosed with colon cancer
  • Lifestyle choices
    e.g. History of smoking
  • Environmental exposures
    e.g. Previous exposure to radiation
Our complete clinical history questionnaire detailing potential risk factors for cancer can be found here.

What genes and markers are analyzed in CancerIntercept™Detect?

All together, 96 different somatic mutations that occur in nine specific cancer driver genes are analyzed. These markers are found in the following genes: BRAF, CTNNB1, EGFR, FOXL2, GNAS, KRAS, NRAS, PIK3CA and TP53. The full list of included markers can be found here.

What cancer types is CancerIntercept™ Detect designed to detect?

The somatic (acquired in the tumor cells) alterations included in this test have been associated with colorectal, breast, ovarian, lung cancers as well as melanoma and other cancer types. Below is a table describing the frequency in which somatic mutations in each of nine genes is found in specific cancer types.
The driver gene frequencies for each of the cancer types below are referenced from the COSMIC database (http://cancer.sanger.ac.uk/cosmic). These values are not necessarily the detection rates found via liquid biopsy or the CancerIntercept™ screen.

Cancer Intercept Chart

What is the limit of detection (LOD) of the test?

Depending on the amount of cell-free DNA isolated, our proprietary technology and analysis enables the reporting of as few as two mutant DNA copies per 5-ml blood plasma sample as the lower limit of detection.
The LOD for each mutation were determined in each run based on input. In our validation, the 100% detection limit at 300, 100, 50, and 10 ng total DNA input was 0.01%, 0.025%, 0.06%, and 0.25% mutant DNA, respectively. Collectively, the detection sensitivity of mutations across the full range of input (10-300 ng) was 78.5%, 98.6%, and 100% for mutations with copy numbers between 2-5, 5-9, and >9, respectively.

How do I order the CancerIntercept™ Detect?

Physicians can contact Pathway Genomics by phone, email, or via our website to submit their information and set up an account. Once the physician is registered and a request for kits is made, Pathway Genomics will ship sample collection kits to the address provided. Once the sample has been collected, the physician can send back the kit with the required and completed paperwork using the prepaid package included with each kit.
Patients can also order CancerIntercept™ Detect online through Pathway Genomics’ online physician network. After speaking with a client services representative, the patient must create a personal account with Pathway Genomics Member Site (members.pathway.com) and enter all personal health information into the website for physician review. It will take up to 1-2 business days for physician review, at which time a sample collection kit will be sent to the patient’s primary care physician or to the phlebotomist if the test is approved. For more information about this process, please view the CancerIntercept™ Detect website.
If you have additional questions, please contact our Client Services department at 877-505-7374 or clientservices@pathway.com.

What are the specimen requirements for CancerIntercept™ Detect?

A blood sample must be collected using the specialized specimen collection tubes provided in Pathway Genomics’ collection kit (2 cell-free DNA BCT tubes, each requiring 10-mL of blood). Please label each tube with two unique identifiers for the patient (patient name and date of birth are required).

Is CancerIntercept™ Detect covered by insurance?

Pathway Genomics will bill a patient’s insurance directly for the test. However, coverage for the test will ultimately depend on the individual patient’s insurance plan, including copayments and deductibles.
Click here to learn more about Pathway Genomics’ billing process.

CancerIntercept™ Monitor

Who should be tested with CancerIntercept™ Monitor?

This test may be beneficial for patients who have been diagnosed with one of the following cancers: colorectal, breast, lung, and ovarian cancers, melanoma and possibly other cancer types. CancerIntercept™ Monitor may especially benefit individuals who have advanced disease, whose treatment has failed, who do not have enough tumor tissue to test, who are not healthy enough to undergo one or more tissue biopsies, or whose primary cancer site is unknown.

What are the indications for CancerIntercept™ Monitor?

  • Tumor profiling
  • Monitor treatment efficacy
  • Monitor disease progression and tumor evolution
  • Monitor residual disease and/or disease recurrence

What genes and markers are analyzed in CancerIntercept™ Monitor?

BRAF, CTNNB1, EGFR, FOXL2, GNAS, KRAS, NRAS, PIK3CA and TP53. Altogether 96 different somatic mutations that occur in these specific cancer driver genes are analyzed. The full list of included markers can be found here

What cancer types does CancerIntercept™ Monitor detect?

Somatic alterations (acquired in the tumor cells) in the genes tested have been implicated in colorectal, breast, ovarian, lung cancers as well as melanoma and other cancer types. Below is a table describing the frequency in which somatic mutations in each of nine genes is found in specific cancer types. The driver gene frequencies for each of the cancer types below are referenced from the COSMIC database (http://cancer.sanger.ac.uk/cosmic). These values are not necessarily the detection rates found via liquid biopsy or the CancerIntercept™ screen.Cancer Intercept Chart

What is the limit of detection (LOD) of the test?

Depending on the amount of cell-free DNA isolated, our proprietary technology and analysis enables the reporting of as few as two mutant DNA copies per 5-ml blood plasma sample as the lower limit of detection. The LOD for each mutation were determined in each run based on input. In our validation, the 100% detection limit at 300, 100, 50, and 10 ng total DNA input was 0.01%, 0.025%, 0.06%, and 0.25% mutant DNA, respectively. Collectively, the detection sensitivity of mutations across the full range of input (10-300 ng) was 78.5%, 98.6%, and 100% for mutations with copy numbers between 2-5, 5-9, and >9, respectively.

Does CancerIntercept™ Monitor predict individual patient response to chemotherapy or provide prognosis?

While this test can provide information about potential targeted treatment options based on the tumor profile and specific genomic alterations, it cannot predict a patient’s response to chemotherapy with certainty. However, recent studies have suggested the presence of elevated amounts of ctDNA in cancer patients correlates with a poor prognosis. In addition, the ordering physician may request to have clinical trial information specific to the tumor type and detected mutation included in the laboratory report.

Does CancerIntercept™ Monitor replace tissue biopsy?

While CancerIntercept™ Monitor has a high detection rate of circulating tumor DNA, it complements traditional tumor biopsies. There are important histopathological analyses performed from tissue that aid in the diagnosis and treatment decisions. Both tests types provide complementary information regarding the tumor’s genomic makeup in order to assist in therapy selection. In cases where a traditional tumor biopsy is not a viable option or for continued tumor monitoring during therapy, CancerIntercept™ Monitor can be used as an alternative method for tumor profiling.

How do I order the CancerIntercept™ Monitor?

Physicians can contact Pathway Genomics by phone, email, or via our website to submit their information and set up an account. Once the physician is registered and a request for kits is made, Pathway Genomics will ship sample collection kits to the address provided. Once the sample has been collected, the physician can send back the kit with the required and completed paperwork using the prepaid package included with each kit. If you have additional questions, please contact our Client Services department at 877-505-7374 or clientservices@pathway.com.

What are the specimen requirements for CancerIntercept™ Monitor?

A blood sample must be collected using the specialized specimen collection tubes provided in Pathway Genomics’ collection kit (2 cell-free DNA BCT tubes, each requiring 10-mL of blood). Please label each tube with two unique identifiers for the patient (patient name and date of birth are required).

Is CancerIntercept™ Monitor covered by insurance?

Pathway Genomics will bill a patient’s insurance directly for the test. However, coverage for the test will ultimately depend on the individual patient’s insurance plan, including copayments and deductibles.Click here to learn more about Pathway Genomics’ billing process.

Is there a financial assistance program available at Pathway Genomics?

Yes, the Pathway Genomics’ Financial Assistance Program (FAP) assists patients with financial hardship who cannot afford to pay the balance due for tests after the claim has been processed by the insurance company. It is also available for cash pay patients. The FAP may not be available in some states.To apply, a patient must fill out the Financial Assistance Program Application form. Please note that the form requires documentation of income, a description of the financial hardship and other information required to determine eligibility for a hardship discount.Please contact the Pathway Genomics’ Billing Department at billing@pathway.com or 877-559-1590.

Contact us for any additional questions:

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MAILING ADDRESS
Pathway Genomics Corporation
4755 Nexus Center Drive
San Diego CA, 92121

Client Services
CLIENT SERVICES DEPARTMENT
(858) 450-6600
(877) 505-7374
clientservices@pathway.com

Partnership
PARTNERSHIPS
Domestic: usbizdev@pathway.com
International: intlbizdev@pathway.com

Marketing & Media
MARKETING AND MEDIA RELATIONS
pr@pathway.com

Genetic Counseling
GENETIC COUNSELING DEPARTMENT
counselors@pathway.com