• AspenBio Pharma (Castle Rock, Colorado) reported that it has outlined plans for submitting its final data package to the FDA for market clearance of AppyScore, which the company calls the first blood-based screen/triage test for appendicitis. AspenBio said that emergency room physicians will be able to use the device as part of a complete clinical workup. The key metric for the clinical study is the device’s Negative Predictive Value, which AspenBio says has been shown consistently in pre-FDA clinical studies to be about 98%. In order to receive FDA clearance, AspenBio must demonstrate the performance characteristics of its final GMP-validated device. This includes non-clinical laboratory performance testing, like assay precision and analytical sensitivity, as well as clinical testing in the field. AspenBio has selected a manufacturer for the AppyScore Screen Test with experience in manufacturing in vitro diagnostic devices, according to 21 CFR 820, and which has been registered with the FDA to manufacture these types of devices. AspenBio is a biopharmaceutical company developing diagnostics and drugs for humans and animals.

• NeoGuide Systems (San Jose, California) said it has refocused its business on the emerging area of Natural Orifice Transluminal Endoscopic Surgery (NOTES). NOTES is a surgical technique that allows procedures to be conducted using the body’s natural orifices as entry points, minimizing the pain, scarring, recovery time and complications found with open and laparoscopic procedures. NOTES is already being performed worldwide in procedures such as tubal ligations and gallbladder removal. NOTES procedures are now conducted with traditional flexible endoscopes, which were designed for use in endoluminal procedures such as colonoscopy and upper GI endoscopy. NeoGuide expects its proprietary robotic endoscopic technology, which was originally developed for application in colonoscopy, to provide unparalleled access to the abdominal and thoracic cavities as well as a stable, force-bearing platform from which surgical tasks can be performed. NeoGuide makes robotic endoscopic technology.

• Provista Life Sciences (Phoenix) said it has completed clinical trials on a new blood test for the early detection of breast cancer. The test is called the BT test (biomarker translation test) and is being made available to a select number of physicians in the Phoenix market as part of the company’s initial market release. The test is designed to assist physicians in making an earlier and more accurate diagnosis of breast cancer when used adjunctively with a mammogram. It uses a proprietary algorithm to evaluate the levels and relationship of multiple, cancer associated protein biomarkers in blood serum. This data is coupled with a patient’s personal medical profile to generate a comprehensive report designed to assist healthcare providers in making an earlier diagnosis of breast cancer. Provista Life Sciences is a diagnostic development company.

• Sequenom (San Diego) reported New York State approval of the first non-invasive prenatal test based on Sequenom’s SEQureDx Technology for Cell Free Fetal Nucleic Acid assessment. The laboratory developed test (LDT) performed on a real-time PCR (RT-PCR) platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom’s nonexclusive licensee, CLIA-certified, New York State Permitted laboratory Lenetix Medical Screening Laboratory, Inc., Mineola, New York. RhD blood group incompatibility between a pregnant woman and her fetus is a significant problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of the newborn. Alloimmunization most frequently occurs when an RhD negative mother is exposed to red blood cells of an RhD positive fetus, producing maternal antibodies against the RhD antigen. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and in the worst cases, fetal death, according to Sequenom. Sequenom makes genomic and genetic analysis products for research and the molecular diagnostic markets.