• Biodesix (Broomfield, Colorado) reported U.S. commercial availability of VeriStrat, a blood-based, proteomic test for patients with advanced stage non-small cell lung cancer (NSCLC). VeriStrat identifies patients who are likely to have good or poor outcomes following treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as erlotinib. VeriStrat, in addition to other clinical factors, provides information to help oncologists make more informed decisions regarding treatment selection. VeriStrat uses mass spectrometry paired with Biodesix' algorithms to determine a patient's VeriStrat classification: VeriStrat Good or VeriStrat Poor. VeriStrat is a pretreatment serum, proteomic test for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with EGFR-TKIs. Samples are processed in Biodesix' CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment.

• Clarient (Aliso Viejo, California) has introduced a new breast cancer test that helps physicians identify the probability of a patient's cancer recurring and assess the need for chemotherapy. The new prognostic test, Insight Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. The Insight Dx Breast Cancer Profile combines three traditional pathology staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC.

• DxNA (St. George, Utah) said that it is developing a diagnostic test for its GeneSTAT pathogen detection platform to detect the swine flu virus in roughly 45 minutes, using a device weighing less than 10 pounds. The Company said it anticipates having a product ready for evaluation in one to two weeks. The GeneSTAT platform includes a device that offers portability and remote usage to rapidly detect pathogen outbreaks. The device also is suitable for use in gateway airports, at health departments and schools, where on-site, rapid and non-invasive screening is advised. The GeneSTAT test module requires only a swab of the mouth, nose or throat. The company said it is developing follow-on tests to detect pathogens that may affect people and agriculture.

• Eight studies presented this week at the annual meeting of the American Urological Association (AUA; Linthicum, Maryland) suggest that and investigational test from Gen-Probe (San Diego) for the prostate cancer gene PCA3 may help challenges faced when diagnosing prostate cancer, such as accurately identification of aggressive cancers while minimizing false positive results that lead to overtreatment. PCA3 is a gene that is highly over-expressed in more than 90% of prostate tumors, indicating that it as a biomarker for prostate cancer. Gen-Probe said that studies have shown that because PCA3 is specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen tests.

• Instrumentation Laboratory (IL; Bedford, Massachusetts) said it received FDA clearance for the ACL AcuStar Hemostasis Testing system. IL says the ACL AcuStar is the first specialty-test analyzer that offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform, can now be performed in as little as 25 minutes, with no special training required. The AcuStar uses chemiluminescence technology, broadly considered the most accurate and sensitive method for routine immunoassay testing.

• Howard Leight (Smithfield, Rhode Island) has introduced QuietDose a personal dosimeter that measures and records a worker's actual in-ear exposure to noise over an entire work shift. The product is designed towards stopping the progression of occupational hearing loss and ensuring employer compliance with hearing safety regulations. The QuietDose system consists of a small Exposure Smart Protector (ESP) Dosimeter that's worn by employees in a shirt pocket or on the back of a hardhat; protective eartips or an earmuff with integrated microphones that record real-time in-ear noise levels; and a connecting harness. An infrared reader enables safety managers to retrieve data from the ESP Dosimeter at the end of each shift or work week and analyze the results on a personal computer.

• Jubilant Organosys (Noida, India) said that its subsidiary in the U.S., Draximage, has received FDA approval for the company's Abbreviated New Drug Application (ANDA) for Draximage's generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite. The Sestamibi is a generic kit used in the preparation of Technetium (Tc-99m) Sestamibi injection - a diagnostic cardiac imaging agent used in myocardial perfusion imaging to evaluate the flow of blood to the heart.

• Perceptive Informatics (Boston) said that it has developed a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer's disease. The method, based on measuring ventricular size, provides a new approach to monitor brain atrophy in Alzheimer's disease and potential treatment effects. The company says the advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer's treatments in development. To develop this method, the Perceptive Informatics team collected MRI scans from the ADNI database using Perceptive's medical imaging system and regulatory compliant processes.