Test Can “Smell” Prostate Cancer
Researchers at the University of Liverpool have shown that a diagnostic test can “smell” prostate cancer in men’s urine. The pilot study included 155 men presenting to urology clinics – 58 were diagnosed with prostate cancer, 24 with bladder cancer and 73 with haematuria and or poor stream without cancer. The test is described in a paper in the Journal of Breath Research called The use of a gas chromatography-sensor system combined with advanced statistical methods, towards the diagnosis of urological malignancies. “There is currently no accurate test for prostate cancer, the vagaries of the [prostate-specific antigen] test indicators can sometimes result in unnecessary biopsies, resulting in psychological toll, risk of infection from the procedure and even sometimes missing cancer cases. Our aim is to create a test that avoids this procedure at initial diagnosis by detecting cancer in a non-invasive way by smelling the disease in men’s urine. A few years ago we did similar work to detect bladder cancer following a discovery that dogs could sniff out cancer,” says professor Norman Ratcliffe.
FDA Extends Comment Period for Guidance
The FDA is extending the comment period by 30 days for its draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. Comments were due by March 28, but the new date is April 28. The FDA says the extension comes in response to requests to give interested people additional time to submit comments ().
USPTO Grants Patent to Oragenics
Oragenics scored a U.S. patent protection for the generation SMaRT Replacement Therapy for live biotherapeutic compositions and methods for preventing dental caries. The USPTO issued the ’488 patent, “Replacement Therapy for Dental Caries,” which gives Oragenics a 17-year patent protection period for SMaRT. The patent protects SMaRT compositions and delivery forms, including mouthwash, toothpaste, chewing gum, floss, chewable tablet, food and beverages. “The SMaRT Replacement Therapy was designed to be a painless, one-time, five-minute topical treatment applied to the teeth that has the potential to offer lifelong protection against tooth decay,” said Jeffrey Hillman, co-inventor of SMaRT Technology and co-founder of Oragenics.
Medtronic Snags FDA Approval
The FDA granted an approval to Medtronic for its deep brain stimulation therapy for people with Parkinson’s with recent onset of motor complications. “This decision by the FDA is significant in that Medtronic DBS Therapy may be considered before the symptoms and complications of disease becomes severe,” according to Mahlon DeLong, the W.P. Timmie professor of neurology at Emory University School of Medicine, in a statement. As a result of the FDA’s action, Medtronic DBS therapy may be used on patients who have had Parkinson’s for at least four years, along with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication.