Also read about a new at-home fertility test and sperm storage kit, a first-in-category assay for Mycoplasma genitalium, and more.
Male sling redesigned for ease of placement, improved stability
Boston Scientific has launched the AdVanceTM XP Male Sling System, a next-generation, minimally invasive solution for male stress urinary incontinence. The AdVance XP Male Sling System has been redesigned for ease of placement and improved stability and is available in longer sling lengths to accommodate larger patient anatomy. The device leverages the success of the previous AdVance Male Sling System platform, with added benefits including the addition of a chevron anchoring mechanism designed to enhance tissue fixation, changes to the mesh weave intended to provide uniform load displacement, longer sling length to accommodate larger patient anatomy, and helical shaped trocars to better support the male anatomy.
For more information, visit www.bostonscientific.com.
At-home fertility test, sperm storage kit launched
A new at-home fertility test and sperm storage kit, which is FDA-licensed in all 50 states, provides men a low-cost, long-term option for storing young, healthy sperm, according to Dadi, its manufacturer. A patented temperature-controlled at-home fertility test and sperm collection kit each come with a specialized cup, which allows for accuracy and real-time updates throughout the process. To ensure secure end-to-end shipping and delivery, the cup is designed with a unique preservative that protects the customer’s deposit for up to 48 hours and throughout the entire overnight shipping process to Dadi’s cryogenic laboratory. Deposits are then analyzed and cryopreserved in a liquid nitrogen tank at –321°F. Once the process is complete, customers receive a personalized fertility report stating the volume, count, and concentration of the sperm in the deposit. The report also includes a microscopic video of the customer’s actual sperm. Customer information is highly confidential, including the fertility report.
For more information, visit www.dadikit.com.
Novel catheter design has potential to reduce urethral trauma
The FDA has cleared Safe Medical Design, Inc.’s Signal Catheter for commercialization in the United States. Signal Catheter features a novel design and has the potential to reduce urethral trauma as a result of premature balloon inflation during placement, according to the company. Safe Medical Design said it planned to begin distribution as part of its early access program in February 2019.
For more information, visit www.safemedicaldesign.com.
FDA approves first-in-category assay for Mycoplasma genitalium
The FDA has granted clearance for the Aptima Mycoplasma genitalium assay, an FDA-cleared test to detect this sexually transmitted infection, according to Hologic Inc. The first-in-category assay, cleared through the FDA’s de novo request process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify infections and enable effective treatment. In published research, Hologic’s ribosomal RNA-based M. genitalium assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests.
For more information, visit www.hologic.com.
Prostate cancer guide offers information for patients, caregivers
The Prostate Cancer Foundation’s updated 2019 Patient Guide is now available. Compiled with the contributions of leading physicians and researchers in prostate cancer, the guide focuses all of the information available about contemporary prostate cancer research, treatment, and lifestyle factors into a single document. According to the Prostate Cancer Foundation, the guide is for any man who has been newly diagnosed, who is in treatment, or is concerned about a rising PSA. It is also a source of information for loved ones or caregivers, as well as a guide for family members who might want to understand how their shared genes affect their own risk factors.
For more information, visit www.pcf.org.
Laboratory licenses urine-based bladder cancer test
Pangea Laboratory recently announced the licensing of a new urine-based laboratory-developed test for bladder cancer detection. Commercialized and sold under the name Bladder CARE, the test is noninvasive, cost-effective, and epigenetic-based, Pangea Laboratory says. Urine samples for the Bladder CARE test can be collected comfortably at home or at the doctor’s office and mailed to Pangea Laboratory for analysis. Pangea Laboratory conducted a pre-clinical collaborative study with Zymo Research, in which 182 urine samples were analyzed using Bladder CARE. The cohort consisted of 97 urine specimens collected from bladder cancer patients and 85 healthy control samples. The study showed that Bladder CARE has 93.8% sensitivity, 85.9% specificity, 88.4% positive predictive value, and 92.4% negative predictive value.
For more information, visit www.pangealab.com.