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FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test

by | Dec 3, 2019 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of prostate specific antigen (PSA) in the blood are notoriously unreliable. High PSA levels may be a sign of not only prostate cancer but infection, inflammation or other disease. Another problem with current PSA PSA testing is that it over detects for low-grade cancer that don’t pose a threat to the patient but result in unnecessary biopsies or treatment that does more harm than the actual cancer.

The New Blood-Based PSA Test

On Oct. 17, 2019, Cleveland Diagnostics, Inc., a company partly owned by the Cleveland Clinic dedicated to developing next-generation diagnostic tests for early cancer detection, announced that it has received FDA breakthrough device for a test that uses a new and more accurate methodology for detecting prostate cancer risk: The so-called IsoPSA test doesn’t simply measure PSA levels but evaluates structural changes to the PSA protein allowing for more accurate differentiation between cancer and non-cancerous conditions; it is also capable of identifying whether cancer detected is serious and needs to be treated or benign enough to be left under “active surveillance.” Securing FDA breakthrough designation expedites the approval process and brings Cleveland Diagnostics significantly closer to its goal of getting final approval to market the test in the U.S. in 2020.

Genetic Tests for Early Prostate Cancer Detection

When and if it reaches the market, IsoPSA faces competition from commercially available genetic tests using biomarker detection and algorithm technologies to assess a patient’s risk of prostate cancer and avoid unnecessary biopsies. Such products include:

  • Prostate Health Index (PHI) (Beckman Coulter), which uses a mathematical formula calculating prostate cancer probability by combining PSA, free PSA and p2PSA tests into a single score;
  • 4Kscore (OPKO Health), which calculates a patient’s percentage risk for aggressive prostate cancer by combining four prostate-specific kallikrein assay results with clinical information in an algorithm;
  • SelectMDx (MDxHealth), a urine test that measures the expression of two mRNA cancer-related biomarkers that, when combined with the patient’s clinical risk factors, provides a score assessing whether patient needs a biopsy or active surveillance;
  • ExoDx Prostate (IntelliScore), aka, The EPI Test (Exosome Diagnostics), which analyzes a urine sample for three biomarkers of aggressive prostate cancer and uses an algorithm to assess the results and generate a score for use in determining whether a biopsy is necessary; and
  • Mi-Prostate Score (MiPS) (Michigan Medicine), which combines the amount of serum PSA with the amounts of two genes for prostate cancer in the patient’s urine for early prostate cancer detection PROGRAMS AND PART

New FDA Approvals

Here’s a look at other new FDA product approvals announced between late October and mid-November:


Manufacturer(s) Product(s)
NantHealth 510(k) clearance for Omics Core technology to measure overall tumor mutational burden in cancer tissue and report somatic mutations in 468 cancer-relevant genes
Siemens Healthineers Clearance for Atellica IM Total hCG assay for quantitative measurement of human chorionic gonadotropin in human serum or plasma, using firm’s Atellica IM Analyzer
Thermo Fisher Scientific Clearance received clearance for iSensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in dilution range of 0.03/4-256/4 µg/mL
DiaSorin Marketing clearance for Liaison XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies previously cleared for emergency use only
DiaSorin Clearance Liaison Vitamin B12 chemiluminescent immunoassay for quantitative measurement of vitamin B12 on Liaison XL analyzer
Microbiologics Clearance for Cepheid Xpert Respiratory Control Panel
iXensor Clearance for PixoTest POCT Analyzer and PixoTest A1c Test Kit for quantitative measurement of glycated hemoglobin (HbA1c) in fingerstick capillary and venous whole blood samples
Fujirebio Diagnostics Clearance for Lumipulse G CA19-9-N chemiluminescent enzyme immunoassay for quantitative measurement of CA19-9 in human serum or plasma, running on firm’s Lumipulse G System
Lin-Zhi International Clearance for LZI Methadone II Enzyme Immunoassay for qualitative and semi-quantitative determination of methadone in urine
Horiba Clearance for Yumizen C1200 CRP reagent for quantitative measurement of C-reactive protein in human serum and plasma based on immunoturbidimetric assay
GeneOhm Sciences Canada Clearance for BD Max Vaginal Panel running on BD Max System
NG Biotech Clearance for NG-Test Carba 5 multiplex immunochromatographic assay to detect carbapenemase enzymes in bacterial colonies
Alpco Clearance for Calprotectin Chemiluminescence ELISA for quantitative measurement of fecal calprotectin
MRIGlobal Clearance for Applied Biosystems Bacillus anthracis Detection Kit
Exact Sciences Breakthrough device designation for hepatocellular carcinoma test
Vela Diagnostics Clearance for Sentosa SQ HIV Genotyping Assay, NGS-based HIV-1 drug resistance mutation assay
Affinimark Technologies Breakthrough device designation for cerebrospinal fluid test strip
Myriad Genetics Approval of myChoice CDx as companion diagnostic for determining patient’s homologous recombination deficiency (HRD) status and who can benefit from niraparib (GlaxoSmithKline’s Zejula)


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:


Manufacturer(s) Product(s)
Paige CE marking for Paige Prostate solution and Insight viewer AI-based prostate cancer detection products
Bioneer CE marking for AccuPower HCV Quantitative RT-PCR Kit quantifying HCV viral RNA from blood samples using ExiStation, Bioneer’s semi-automated real-time qPCR molecular diagnostic system
Biocept CE marking for CEE-Sure blood collection tube and CEE-Sure sample collection shipping kit
Proscia CE marking for Concentriq Dx digital pathology software for use in primary diagnosis
BioGx CE-IVD marking for expanded respiratory infection assay called OSR for BD Max


Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
FindGene Clinical Laboratories China National Medical Products Administration approval for noninvasive prenatal screening test kit
Biolidics China National Medical Products Administration Class I registration for ClearCell FX1 liquid biopsy platform that separates and enriches cancer cells from a blood sample


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