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PROSTATENOW™ - Validated Germline Testing for Prostate Cancer

Prostate cancer is not usually considered an inherited disease, but a recent study found that 57% of prostate cancer is caused by genetic factors.

PROSTATENOW™ is a comprehensive germline genetic test for people with prostate cancer. PROSTATENOW™ gives you and your physician the best data to make informed decisions about screening and treatment for prostate cancer.

What Is Germline Testing?

Germline genetic testing looks for inherited mutations in a person's DNA. Germline mutations in several genes, especially genes that repair DNA, are associated with prostate cancer progression.

A germline mutation is present in virtually every cell in the body, so the sample used for the test for a germline mutation is easy to get from blood or saliva.

PROSTATENOW™ Assesses a Patient’s Risk Based on Three Methods

Family History
Relatives of people with a prostate cancer diagnosis have a 1.5-to-2.5-fold increased risk of developing prostate cancer. The risk of prostate cancer may also be increased in those with relatives diagnosed with breast cancer.

Rare Pathogenic Mutations
Rare pathogenic mutations (RPM) are DNA mutations that can cause disease. RPMs are associated with a moderate-to-high risk for developing prostate cancer. There is also a risk of more aggressive prostate cancer if RPMs are present. Some of the RPMs that PROSTATENOW™ tests for are:
  • BRCA2
  • ATM
  • CHEK2

Genetic Risk Score
The genetic risk score (GRS) is used to assess a man’s risk of developing prostate cancer compared to other men in the general population. The calculation of risk is based on more than 100 single nucleotide polymorphisms (SNPs), a type of genetic variation, associated with prostate cancer risk.

What Are the Benefits of a PROSTATENOW™ Test?

Assess Prognosis for Localized Prostate Cancer Patients
PROSTATENOW™ test provides more information about RPMs to predict disease progression. Traditional clinical variables like the Gleason Score and PSA levels may not provide enough information to your physician to make the best treatment recommendations. The GRS and information about RPMs can inform a personalized plan for prostate cancer treatment, like choosing active surveillance or definitive treatment with either surgery or radiation.

A recent study shows that men with RPMs in BRCA1/2 and ATM may benefit from earlier definitive treatment.

Recommends Therapeutic Responses for Advanced Cancer Patients
The presence of RPMs can predict how well certain treatments may work. A PROSTATENOW™ test provides information about RPMs to make a personalized decision about drug treatments.

For example, studies show that men with certain RPMs may have a better response to specific treatments, like PARP inhibitors and platinum chemotherapy.

Assess Risk for Unaffected Men
The National Comprehensive Cancer Network recommends germline testing for prostate cancer in men unaffected by prostate cancer that meet family history criteria.

The family history criteria include:
  • Family history of RPMs
  • Ashkenazi Jewish ancestry
  • One or more relatives with a breast cancer diagnosis at less than 50 years old; ovarian cancer; exocrine pancreatic cancer; or metastatic, regional high, or very high-risk prostate cancer at any age
  • Father or brother with a prostate cancer diagnosis at less than 60 years old
  • Two or more relatives with breast cancer or prostate cancer at any age
  • Three or more relatives with Lynch syndrome-related cancers, especially if diagnosed before age 50

Discovering a personalized risk of developing prostate cancer can inform decisions about how often to test and the chance of passing this risk to offspring.

Why Should You Choose PROSTATENOW™?

Clinically Validated
PROSTATENOW™ is developed by top scientists and is supported by peer-reviewed publications that support the use of GRS in addition to FH and RPM.

PROSTATENOW™ is also recommended by the National Comprehensive Cancer Network’s guidelines.

Comprehensive Inherited Risk Assessment
PROSTATENOW™ is the only commercially available germline panel to include all three elements of risk (FH, RPM, and GRS) to deliver a comprehensive inherited risk assessment. Using all three of these elements of risk, physicians can better determine who might benefit from earlier screening and treatment.

Genetic Counseling
A qualified genetic counselor will support you through the entire testing process from start to finish. The genetic counselor will walk you through questions related to your medical and family history and help you understand your results.

How Does PROSTATENOW™ Testing Work?

Patient Consult
Men with a prostate cancer diagnosis and unaffected men with a qualifying family history should speak to their physician to discover the benefits of PROSTATENOW™.

Sample Collection
PROSTATENOW™ testing can be performed using either a blood or saliva sample. A blood sample is collected at a medical facility. A saliva sample can be provided in a physician’s office or at home.

Sample Processing
Your sample is analyzed in a GoPath laboratory. They will analyze genes, test for germline mutations, collect data about RPMs, and calculate a GRS.

Results
The PROSTATENOW™ report is available in 10 to 14 days.

A genetics counselor will be provided by GoPath Laboratories to discuss the results and next steps.

Paying for PROSTATENOW™

PROSTATENOW™ is covered by Medicare for qualifying patients.

GoPath Laboratories accepts all commercial insurance plans. GoPath Diagnostics will review insurance information and submit a prior authorization request to make sure it is covered and find out if any out-of-pocket costs are required.

Financial assistance is available for qualifying patients who have out-of-pocket costs for PROSTATENOW™ testing.

References:
  1. https://jamanetwork.com/journals/jama/fullarticle/2480486
  2. https://pubmed.ncbi.nlm.nih.gov/34674288/
  3. https://onlinelibrary.wiley.com/doi/10.1002/ijc.33024
  4. https://pubmed.ncbi.nlm.nih.gov/30309687/
  5. https://pubmed.ncbi.nlm.nih.gov/30919167/
  6. https://www.cancernetwork.com/view/journal-germline-testing-in-prostate-cancer-when-and-who-to-test
  7. https://pubmed.ncbi.nlm.nih.gov/33257031/











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