Immucor (Norcross, Georgia), a provider of automated instrument-reagent systems to the blood transfusion industry, said the FDA notified the company that it has reviewed Immucor's response to a previously-reported warning letter, and Immucor's proposed corrective actions appear to be adequate.
The FDA said it would evaluate the implementation and effectiveness of those corrective actions, as well as Immucor's overall compliance, at its next inspection.
The warning letter, which related to Immucor's internal quality system, was dated May 2, and the company responded on May 22, detailing the corrective actions it proposed to take.
Immucor CEO Gioacchino De Chirico said, "We take our regulatory responsibilities very seriously and worked diligently to respond to the FDA. We are pleased the FDA accepted our action plan, and was willing to move as quickly as it did. We have already begun implementing the plan."
PreMD loses Amex support
Predictive Medicine Co. (PreMD; Toronto) said it has been notified by the American Stock Exchange (Amex) that it will not continue to support PreMD's plan for regaining compliance with the continued listing standards and that it intends to delist the company's common stock from the exchange by filing a delisting application with the SEC pursuant to Section 1009(d) of the Amex company guide.
The determination by the staff of the Amex to initiate the delisting of the common stock from the Amex is based on the company's failure to meet several of the exchange's conditions for continued listing.
PreMD specializes in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases.
Atherotech test covered by Tricare
Atherotech (Birmingham, Alabama) said that its VAP cholesterol test now is covered by Tricare, the Department of Defense's healthcare plan for the uniformed services, retirees and their families.
The announcement means that the VAP Test will now be available to the more than 9 million beneficiaries enrolled in the Military Health System (MHS) through Tricare. The MHS provides quality medical care through a network of providers, military treatment facilities, medical clinics and dental clinics worldwide.
The VAP Test directly measures LDL. Atherotech says the test also is the only commercially available test that meets new American Diabetes Association and American College of Cardiology (ADA-ACC) cholesterol guidelines for people at high risk of heart attack and stroke (including people with Type 2 diabetes). The ADA-ACC consensus statement establishes measurement and treatment guidelines for apoB in addition to LDL and non-HDL in high-risk patients.
Atherotech is a cardio-diagnostic company.
NCI uses advanced imaging to view cancer gene
A research team led by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), has applied advanced imaging methods and computer simulations to be able to glance at the regulation of a cancer-related gene in a living cell. They found that the efficiency with which the components of the cell's gene-reading machinery come together has an impact on gene expression, the process by which a gene translates its information into a new protein.
A key question regarding how the cell controls gene expression relates to interactions between genes and certain gene reading proteins, and between genes and transcription factors, which regulate gene transcription from DNA to RNA. The process requires the assembly of numerous transcription complexes, particularly one called RNA polymerase, at the site of a gene's promoter (the stretch of DNA before the start of a gene to which transcription factors bind) at the right time.
From earlier work done primarily by NCI researchers, the interactions among transcription factors, and between them and their target DNA, is known to be highly dynamic. What has remained unclear is whether this dynamic nature itself serves some role in regulating gene activity.