• Ariosa Diagnostics (San Jose, California), maker of the Harmony Prenatal Test, reported the publication of two clinical studies involving twin pregnancies in Fetal Diagnosis and Therapy. he two studies provide information on how to consider use of non-invasive prenatal testing (NIPT) with cell-free DNA (cfDNA) in identical (monozygotic) and fraternal (dizygotic) twin pregnancies. Previous studies in singleton pregnancies demonstrated the accuracy of the Harmony test in assessing the risk of fetal trisomy 21, which causes Down syndrome, and other chromosome conditions. The first study highlights the importance of estimating the percentage of fetal fraction (FF) in analyzing twin pregnancies with NIPT. Using NIPT in twin pregnancies is more complex than in singleton pregnancies because the two fetuses can be either monozygotic, meaning both fetuses are genetically identical, or dizygotic, in which case only one fetus is likely to have a trisomy when present. The study concluded that with the Harmony test algorithm, use of the fetal fraction in the analysis of FF for one of the twins will allow for more accurate testing. In the second study, the Harmony test correctly classified 9 of 10 pregnancies with fetal trisomy 21, 1 of 1 pregnancies with fetal trisomy 13, and no false positives. The Harmony test is a blood test for pregnant women that can be used as early as 10 weeks in pregnancy. By evaluating cfDNA from the fetus found in maternal circulation, the test can assess the risk of Down syndrome with greater than 99% accuracy and provide fetal sex information. Compared to current prenatal screening tests that have up to a 20% error rate, the Harmony test with its much higher accuracy, represents a significant advance in prenatal testing, the company said.

• Brainsway (Jerusalem, Israel) has approved an Investigational Device Exemption that allows the company to begin implementing a double-blind, multi-center study to assess the efficacy of the its Deep TMS device in treating patients suffering from obsessive-compulsive disorder. The IDE approval was granted on the basis of the FDA's determination that this is a non-significant risk study. Accordingly, Brainsway intends to act quickly in order to initiate the study following receipt of the requisite Investigational Review Board approvals. Brainsway makes a medical device for the noninvasive treatment of common brain disorders. The device is based on a uniquely shaped electromagnetic coil connected to a rapidly changing current supply, which produces magnetic fields capable of affecting different areas of the brain. Deep brain areas can be either excited or inhibited, depending on the frequency of the magnetic field.

As breast density becomes a more recognized risk factor for breast cancer, Royal Philips (Amsterdam, the Netherlands) reported FDA clearance for the Spectral Breast Density Measurement Application for its MicroDose SI full-field digital mammography (FFDM) system. The application is the first spectral Breast Density Measurement tool, meaning adipose (fat) and glandular tissue can be differentiated to accurately measure volumetric breast density. Although nearly 50% of women have dense breast tissue, a known risk factor for breast cancer, until now, the most frequently used methodology to determine breast density is a visual analysis of an image of the breast. This methodology is highly subjective, meaning several radiologists may allocate a different breast density score for the same image. Rather than estimating density, the Spectral Breast Density Measurement, obtained during a standard, low-dose MicroDose SI mammogram, allows breast density to be objectively measured. The Spectral Breast Density Measurement Application works by measuring independently the glandularity and thickness in each pixel of the image to objectively calculate the total volume and volumetric percentage of glandular tissue in the breast. Once the calculations are completed the examination is automatically assigned a MicroDose density score that correlates to the Breast Imaging-Reporting and Data System (BI-RADS), the manual method for determining breast density. The measurement is displayed on the review workstation together in the DICOM tag of the acquired image and exported for display in a DICOM Structured Report.