web
counter
Call us toll-free at 1-855-420-7140

The Men’s Health Program

mens-health-slider-1000x350

Next Generation Testing for Men's Health

The Prostate Health Index (phi ) is the First Blood Test of its kind to Help Differentiate Prostate Cancer from Benign Conditions

  • phi measures 3 different types of PSA (prostate-specific antigen) and is a more accurate way to assess prostate cancer risk than PSA and percent free PSA alone.4
  • phi values are associated with increased probability of prostate cancer, and with more aggressive disease.4
  • phi can also help differentiate prostate cancer from benign conditions and therefore help reduce unnecessary biopsies(possibly by 26%) in men with elevated PSA levels within a certain range.4

Phi In Clinical Practice

dr.slawin

Learn How Dr. Kevin Slawin, Uses PHI in Clinical Practice at Vanguard Urology in Texas. (Click Photo Above for PDF)

The PSA (prostate specific antigen) test is one of the most common prostate cancer screening methods. However, in recent years, PSA has come under scrutiny for its limited ability to differentiate benign conditions from aggressive cancers. After all, an increase in PSA levels can also be caused by non-cancerous conditions such as prostate enlargement or benign prostate hyperplasi (BPH). Therefore, measuring PSA alone does not necessarily provide enough specific information to physicians to help them determine if patients should move to a more invasive procedure like prostatic biopsy or subscribe patients to active surveillance. That's where the phi test can help play a critical role in helping physicians assess patient prostate health. phi measures 3 different types of PSA and is a more accurate way to assess prostate cancer risk than PSA and percent free PSA alone. In other words, phi helps bridge the diagnostic gap between PSA and Prostatic Biopsy.

How it Works

The phi test measures total PSA (tPSA) in addition to two special forms of the protein: free PSA (fPSA) and pro2PSA (which is associated with more aggressive cancers). Then all three scores are calculated through a sophisticated algorithm to develop an overall phi score.

1

Step 1: An Initial PSA Test is Run
If the PSA test is less than than <2 ng/ml the patient has a lower risk for prostate cancer and phi score is not indicated for this patient. The patient can return next year, at which time phi can be ordered again as part of annual screening. If the PSA reading is >10, the patient should be immediately referred to more aggressive assessment such asprostatic biopsy. Again there is no need to run the remaining of the phi test.

2

Step 2: fPSA, Pro2PSA are run & phi Risk Score is Calculated
If the PSA reading is greater >2 ng/ml and less than <10 ng/ml and the physician orders the test, IDL will run the previously determined total PSA, fPSA, Pro2PSA test along with the phi algorithm to calculate the phi score.

3

Step 3: phi Results are Reported & Acted Upon
If the phi score is high, patients will require more aggressive screening including a referral for biopsy. If the phi score is low, patients can be put into the category of active surveillance and screened again at the next follow-up appointment.


Indications for Use

The Prostate Health Index (phi) is a blood test that is 3 times more specific than PSA*.1,2 phi  is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4 .0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer.  Peer-reviewed published studies support the use of the phi test in men with total PSA values as low as 2 ng.4  Prostatic biopsy is required for diagnosis of cancer.3

Recommended by National Comprehensive Cancer Network (NCCN)

phi has been recommended by the National Comprehensive Cancer Network (NCCN) as a blood test to improve specificity for prostate cancer detection in its Clinical Practice Guidelines in Oncology (NCCN Guidelines)5 for Prostate Cancer Early Detection. Inclusion in the NCCN Guidelines recognizes the benefit and clinical utility of phi to help the appropriate use of prostate biopsy, and therefore help bring about better cancer diagnosis.


A Comprehensive Approach to Men’s Health

IDL offers the following tests for Men’s Health

Prostate Cancer Risk Assessment

  • Prostate Health Index (phi) (PSA, fPSA, Pro2PSA + Algorithm)
  • PSA
  • Percent Free PSA

Male Hormone Testing (Individual or As Panel)

  • Follicle-stimulating hormone (FSH)
  • Dehydroepiandrosterone sulfate (DHEA-S)
  • Sex hormone-binding globulin (SHBG)
  • Total Testosterone
  • Free Testosterone (Calculated)
  • Luteinizing hormone (LH)
  • Estradiol

 Additional Cancer Risk Assessment Tests


Contact Us

You can reach us phone: 1.855.420.7140 or email customer service at clientrelations@myinnovativelab.com


  1. Am J Clin Exp Urol 2014;2(4):343-350
  2. J Urol. 2015 April ; 193(4): 1163–1169. doi:10.1016/j.juro.2014.10.121.
  3. http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090026a.pd
  4. Catalona WJ et al. J Urol 2011;185(5):1650-5.
  5. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer Early Detection. Version 1.2014
*At 90 percent clinical sensitivity.