• 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.
• Energex Systems (Allendale, New Jersey) said that it has notified the FDA of its interest in applying for an Emergency Use Approval that would permit the company to offer its HemoModulation therapy for the treatment of type A, H1N1 swine flu. It said that HemoModulation therapy has been shown to inactivate the virus in mice. This same therapy has been under review by the FDA and is in human clinical trials for Hepatitis C and HIV. HemoModulation therapy uses UVC energy to inactivate the particular strain of virus that the patient is infected with, and returning to the body. The hypothesis is that UV inactivated virus will serve as an autologous vaccine and boost immune systems against their particular strain of virus. The process takes about 30 minutes and can be administered in an office or lab.
• 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.