>>"We are working with Roche Diagnostics to develop the clinical potential of our telomerase detection technology. Research data shows that an assay for telomerase is a more sensitive and specific test for bladder cancer screening than other commercially available tests. We believe that these and other data support the clinical application of telomerase assays in diagnosis, staging, monitoring and screening for bladder, cervical, prostate and other cancers."<<
(emphasis mine)
Oh, really? How recently has that chunk of the website been updated? Because it's just plain wrong, and has been for some time, unless they're keeping some more recent data to themselves that is better (very unlike GERN!). This approach might have looked like the best out there when the deal was inked, but things have changed since then.
>>J Urol. 2001 Apr;165(4):1067-77.
Current bladder tumor tests: does their projected utility fulfill clinical necessity?
Lokeshwar VB, Soloway MS.
Department of Urology, University of Miami School of Medicine, Miami, Florida, USA.
PURPOSE: We reviewed currently available bladder cancer tests in the context of the clinical expectations of a noninvasive bladder cancer test. MATERIALS AND METHODS: We reviewed the literature on bladder cancer tests that are commercially available or have shown clinical usefulness and examined how each test compares with standard methods of bladder cancer diagnosis. RESULTS: The clinical necessity for a noninvasive test for bladder cancer is 2-fold, including the early detection of high grade bladder tumors before muscle invasion and monitoring tumor recurrence or new onset. An ideal noninvasive test should be sensitive, specific, rapid, technically simple and have low intra-assay and interassay variability. Urine cytology has high specificity but limited applicability due to its relatively low sensitivity and subjective nature. Hematuria detection by Hemastix dipstick is sensitive but not specific for detecting bladder cancer. Molecules associated with bladder tumor growth and progression may serve as a basis for designing noninvasive diagnostic tests. The Food and Drug Administration approved BTA Stat and BTA TRAK tests, which detect human complement factor H and a related protein in urine, have 60% to 80% sensitivity and 50% to 70% specificity (lower in symptomatic patients) for bladder cancer. The Food and Drug Administration approved NMP22 test, which measures the level of nuclear mitotic apparatus protein in urine, has 50% to 100% sensitivity and 60% to 90% specificity. Accu-Dx detects fibrin degradation products, fibrin and fibrinogen in urine, although this test is no longer commercially available. The Immunocyt test combines cytology with an immunofluorescence technique to improve the sensitivity of cytology for detecting low grade tumors. The telomeric repeat amplification protocol assay for telomerase in exfoliated cells has 70% to 86% sensitivity and 60% to 90% specificity for bladder cancer. However, the low stability of telomerase in urine affects its sensitivity. The hyaluronic acid and hyaluronidase (HA-HAase) test, which measures the urinary level of hyaluronic acid and hyaluronidase, has 90% to 92% sensitivity and 80% to 84% specificity for bladder cancer. Quanticyt karyometry evaluates nuclear shape and DNA content of exfoliated cells to detect bladder cancer. The list of bladder tumor markers is growing rapidly and large multicenter trials are essential to assess their usefulness. CONCLUSIONS: Although currently noninvasive bladder cancer tests cannot replace cystoscopy, some have shown a promise of being clinically useful. One or a combination of these tests-markers may prove to be a prostate specific antigen for bladder cancer provided that patients and, more importantly, clinicians accept it.<<
emphasis mine
Meanwhile, proteomic approaches based on pattern analysis of multiple biomarkers are catching up in bladder cancer, and further refinement will put them ahead, IMO. Meanwhile the lack of stability of telomerase in bodily fluids is going to be a difficult to get around. I do not foresee much improvement for that technique. Single marker assays such as GERN's will give way to multiple biomarker tests in the no too distant future.
>>Am J Pathol. 2001 Apr;158(4):1491-502.
Development of a novel proteomic approach for the detection of transitional cell carcinoma of the bladder in urine.
Vlahou A, Schellhammer PF, Mendrinos S, Patel K, Kondylis FI, Gong L, Nasim S, Wright Jr GL Jr.
Departments of Microbiology and Molecular Cell Biology, Eastern Virginia Medical School, 700 W. Olney Rd., Norfolk, VA 23507, USA. vlahoua@borg.evms.edu
Development of noninvasive methods for the diagnosis of transitional cell carcinoma (TCC) of the bladder remains a challenge. A ProteinChip technology (surface enhanced laser desorption/ionization time of flight mass spectrometry) has recently been developed to facilitate protein profiling of biological mixtures. This report describes an exploratory study of this technology as a TCC diagnostic tool. Ninety-four urine samples from patients with TCC, patients with other urogenital diseases, and healthy donors were analyzed. Multiple protein changes were reproducibly detected in the TCC group, including five potential novel TCC biomarkers and seven protein clusters (mass range, 3.3 to 133 kd). One of the TCC biomarkers (3.4 kd) was also detected in bladder cancer cells procured from bladder barbotage and was identified as defensin. The TCC detection rates provided by the individual markers ranged from 43 to 70% and specificities from 70 to 86%. Combination of the protein biomarkers and clusters, increased significantly the sensitivity for detecting TCC to 87% with a specificity of 66%. Interestingly, this combinatorial approach provided sensitivity of 78% for detecting low-grade TCC compared to only 33% of voided urine or bladder-washing cytology. Collectively these results support the potential of this proteomic approach for the development of a highly sensitive urinary TCC diagnostic test.<<
These folks are funded by Ciphergen, which gets commercial rights to discoveries arising from the use of their SELDI technology.
Message 17284373
I agree that some stem cell researchers have left, but uprooting such folks and their families somewhat involuntarily as a result of a merger is a different thing. That said, I don't know how much stem cell research GERN actually conducts in the U.S. As you mentioned, at least some of it done at Roslin.
Cheers, Tuck |
