MiCheck® Prostate
An Advanced Prostate Cancer Risk Test That Goes Beyond PSA
A Proprietary, Proven Algorithm — Not PSA Alone
An elevated PSA is a question, not an answer. It might mean clinically significant prostate cancer. It might mean benign hyperplasia, inflammation, or a low-grade tumor that will never trouble the patient. PSA alone cannot tell you which, and that ambiguity sends men to biopsy who may not need one. MiCheck® Prostate is an advanced prostate cancer risk test. By way of a proprietary, proven algorithm using multiple biomarkers and the patient's age, a physician no longer has to rely on PSA alone — MiCheck® Prostate produces a single risk score for clinically significant prostate cancer risk. Not a marker to interpret. A number to act on.
Key Benefits:
Risk assessment specific to clinically significant prostate cancer (csPCa) risk
Helps identify which patients truly need biopsy — and which may not
Proprietary, proven algorithm combining three FDA-approved biomarkers and patient age — clinical depth that single-marker PSA cannot match
95% sensitivity and 96% NPV for clinically significant prostate cancer
Up to 62% of unnecessary biopsies could be avoided
Simple, non-DRE blood draw, sent to the lab
Reported as a percentage risk the patient can actually understand
Covered by most insurances and CMS
We bill insurance for your convenience
The PSA Dilemma
When an Elevated Result Raises More Questions Than It Answers
Elevated PSA creates a clinical dilemma rather than resolving one. It may indicate clinically significant prostate cancer. It may equally reflect benign prostatic hyperplasia, prostatitis, recent instrumentation, or indolent low-grade disease that will never require treatment. PSA is a single marker doing a job that a single marker cannot do.
The consequence is unnecessary biopsy — an invasive procedure with real risks of bleeding, infection, and sepsis, and a reliable source of patient anxiety, performed on men who turn out not to have clinically significant disease. The opposite error is quieter but no less serious: cancers missed in men whose PSA never rose enough to raise concern.
MiCheck® Prostate addresses this gap. By way of a proprietary, proven algorithm using multiple biomarkers and the patient's age rather than relying on PSA alone, it produces a risk assessment aimed at clinically significant prostate cancer risk specifically. Better risk stratification means better decisions in both directions — proceeding to biopsy when the risk warrants it, and confidently declining when it does not.
Why the MiCheck® Algorithm:
It targets the disease that matters. csPCa is the disease that requires intervention. Risk assessment aimed at csPCa risk specifically is more clinically useful than a marker that flags everything.
It reduces avoidable procedures. Every biopsy that does not change management is a procedure the patient did not need.
It gives the patient something to hold onto. "Your PSA is elevated" means little to a frightened man on its own. A risk score he can weigh is the beginning of a real conversation.
It supports active surveillance. For men already being monitored, objective risk assessment supports the decision to keep monitoring.
MiCheck® Prostate vs. PSA Alone
Proven, Superior Biomarker Testing
MiCheck® Prostate
- Multiple biomarkers plus patient age, resolved by a proprietary, proven algorithm
- Risk assessment targeted at clinically significant prostate cancer risk specifically
- Supports a defensible, confident decision to defer biopsy
- Reports a percentage risk patients can actually engage with
- Same blood draw, more information
PSA Alone
- A single marker doing a job one marker cannot do
- Elevated by BPH, prostatitis, instrumentation, and indolent disease alike
- Ambiguity frequently resolved by defaulting to biopsy
- A number most patients cannot interpret without help
- Same blood draw, less information
Best-in-Class Test Performance
Validated in the MiCheck-01 Prospective US Trial
MiCheck® Prostate was evaluated in 361 patients in the MiCheck-01 prospective US clinical trial. Its performance is what makes the biopsy conversation different — high sensitivity means increased-risk disease is rarely missed, and high negative predictive value is what lets you and your patient defer a biopsy with confidence.
Stat 1: 95% — Sensitivity. Correctly identifies patients at increased risk for csPCa
Stat 2: 62% — Specificity. Correctly identifies patients not at increased risk for csPCa
Stat 3: 96% — NPV (GS ≥3+4). Higher confidence not missing increased-risk csPCa disease
Stat 4: 99% — NPV (GS ≥4+3). Higher confidence not missing increased-risk csPCa disease
Stat 5: 53% — PPV. Higher confidence in finding increased-risk csPCa disease
Conclusion callout: Applying MiCheck® Prostate to all 361 evaluable patients in the MiCheck-01 study demonstrated that up to 62% of unnecessary biopsies could be avoided, while delaying diagnosis of only 5.3% of Gleason Score (GS) ≥3+4 cancers, 3.5% of GS ≥4+3 cancers, and no cancers of GS 8–10.
Citations: Shore ND, Pieczonka CM, et al. A comparison of prostate health index, total PSA, %free PSA, and proPSA in a contemporary US population — The MiCheck-01 prospective trial. Urologic Oncology, March 2020. • Shore N, Polikarpov D, et al. Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer. Urologic Oncology, Vol 41, Issue 11, November 2023, 454.e9–454.e16.
About the MiCheck® Prostate Test
Proven, Validated Biomarker Analysis from a Routine Blood Draw
MiCheck® Prostate combines three FDA-approved biomarkers — total PSA, free PSA, and HE4 — with the patient's age, resolved through a proprietary, proven algorithm into a single risk score for clinically significant prostate cancer (csPCa, a Gleason score ≥3+4).
A risk score above the validated cut-point of 5% is associated with an increased likelihood of GS ≥3+4 prostate cancer on biopsy; a score below the cut-point is associated with a decreased likelihood. The result is a percentage risk — a number the patient can hold onto and reason about, rather than a PSA value that means nothing to them without translation.
- Men with elevated PSA who are considering an initial biopsy
- Men being closely monitored due to elevated PSA
- As a companion to an indeterminate MRI result
- Biopsy decision support — helping determine whether to proceed to biopsy or continue monitoring
- MiCheck® Prostate is a risk assessment tool. It does not replace biopsy, which remains the diagnostic standard.
- Specimen Type: Serum — a simple, non-DRE blood draw, sent to the lab
- Additional Input Required: Patient age must be supplied on the requisition — the algorithm uses it as an input
- Supplies Provided: Serum tubes, shipping kits, and requisition forms
- Turnaround Time: Reports available within 2–3 days
- Results Delivery: Fax, portal, or EMR integration
Who Should Order MiCheck® Prostate
For the Conversation That Happens After the PSA Comes Back
Urology practices. Prostate cancer risk assessment is core to urologic care. MiCheck® adds biomarker depth to a decision that currently rests too heavily on one number.
Men with elevated PSA. When PSA is elevated but its significance is genuinely uncertain, additional risk stratification is what turns a coin flip into a decision.
Biopsy decision support. For patients and physicians weighing whether to proceed, an objective risk figure gives both parties something to reason from.
Active surveillance programs. Men on surveillance and the physicians managing them both benefit from objective, repeatable risk assessment.
Primary care physicians managing PSA. Much of the PSA burden is carried in primary care. MiCheck® gives the referring physician better information before the urology referral is made.
Our Testing Services
Ensuring Quality and Reliability in Every Test
MiCheck® Prostate is a simple blood draw, sent to SoftCell and resolved through a proprietary, validated algorithm. All testing is performed using current-generation instrumentation and validated protocols, with strict quality assurance on every result. SoftCell is a CLIA-certified, high-complexity reference laboratory, powered by Doc Lab.
Ordering Information
Effortless Access to Advanced Urinalysis Diagnostics
Ordering is simple and convenient, and results are delivered the way that fits your practice — through our secure web portal, by fax, or via EMR integration. New accounts are set up fast, with kits, requisitions, and portal access included. For any questions or assistance, our dedicated client services team is here to help. Contact us at info@SoftCellLabs.com or (503) 402-2505.
Experience the SoftCell Difference
Where Innovation Meets Clinical Excellence
Trust SoftCell for your reference laboratory needs and unlock the power of precise, personalized medicine. Our advanced prostate cancer risk assessment testing can make a significant difference in your practice — improved patient outcomes and more efficient treatment plans. Work with a lab partner that actually answers the phone.