PCA3 test for prostate cancer: Data presented June 1 at the American Urological Association annual meeting shows Gen-Probe's Progensa urine-based molecular test is significantly more specific than prostate specific antigen in detecting prostate cancer. A multi-practice, community-urologist-based clinical trial evaluated PCA3 in 1,994 urine samples from men with elevated serum PSA and/or an abnormal digital rectal exam, of which 1,946 had enough prostatic cells for PCA3 testing. Researchers found that 816 patients (42%) had prostate cancer, and another 219 (11%) had high-grade prostatic intraepithelial neoplasia and/or atypical small acinar proliferation suspicious for cancer. The results concluded PCA3 has an odds ratio of 3.4 for predicting prostate cancer versus 1.7 for PSA. PCA3 had a specificity of 78% and sensitivity of 49%, versus 21% and 87%, respectively, for PSA. The PCA3 gene is overexpressed in more than 90% of prostate cancers. The assay has CE-mark approval in Europe; Gen-Probe initiated a U.S. clinical trial in August 2009 and plans to submit a PMA application later this year
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
