Health Diagnostic Laboratory Adds CYP2C19 Genetic Testing

Health Diagnostic Laboratory Inc announced its new capability to run the CYP2C19 genetic test. HDL Inc, headquartered in the Virginia Biotechnology Research Park, has added CYP2C19 to its comprehensive panel of tests to help physicians better personalize treatment based on an expanded, total patient profile.

“Cytochrome P450 2C19 (CYP2C19) enzyme is involved in the liver’s metabolism of several important drugs,” said G. Russell Warnick, chief scientific officer at HDL Inc and editor of the Handbook of Lipoprotein Testing. “Most notable of those drugs is Plavix® (clopidogrel), an anti-blood clotting medication. Clinicians considering Plavix® as a possible preventative therapy for patients should first have their CYP2C19 test results.”

The FDA released a safety announcement on March 12, 2010, stating that anywhere from 2% to 14% of the population are poor metabolizers of Plavix® based on CYP2C19 function. These patients do not effectively convert Plavix to its active form because of low CYP2C19 activity reducing the effectiveness of the drug as a preventative therapy for heart attacks, unstable angina, stroke, and cardiovascular death.

“There is great significance in adding Cytochrome genetic test, as it demonstrates yet another way that advanced testing at HDL Inc can help provide better preventative therapy and evidence-based treatments.”

HDL Inc has made the CYP2C19 test available immediately to all clinicians. For more information, call 877-4HDLABS; (877) 443-5227.

Source: HDL

New CDC Test to Detect Human Infections with the 2009 H1N1 Influenza Virus

A test developed by the US Centers for Disease Control and Prevention to diagnose human infections with the 2009 H1N1 influenza virus (formerly known as swine flu or pandemic H1N1 flu) was authorized for use today by the FDA.

“The development of this test exemplifies our dedication to improving public health surveillance for the 2009 H1N1 virus and other influenza viruses in the United States and abroad,” said Dr Nancy Cox, director of CDC’s Influenza Division.

The test, called the “CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD),” will help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing in the United States and abroad. It uses a molecular biology technique to detect influenza A viruses and specifically the 2009 H1N1 virus. The new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic, called the “Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel),” which received an emergency use authorization by the FDA in April 2009.

“This clearance represents several months of close collaboration between the FDA and the CDC,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “This test is the second diagnostic cleared in recent weeks by the FDA for the 2009 H1N1 influenza virus.”

Source: CDC

Corgenix Announces Issuance of US Patent for AspirinWorks

Corgenix Medical Corp has been issued an additional US patent covering its AspirinWorks® technology and product line. The patent, issued June 1, 2010, covers the AspirinWorks Test and represents the latest addition to Corgenix intellectual property (IP) portfolio. AspirinWorks is the only FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane A2 (TxA2), the target of aspirin therapy. The test targets a potential global market exceeding 200 million individuals.

US Patent No. 7,727,730 B2, “Methods and Kits for Detection of Thromboxane A2 Metabolites,” recognizes the ability of the AspirinWorks Test to accurately measure additional biomarkers of platelet inhibition. Specifically, the patent relates to the AspirinWorks Test’s ability to more accurately depict the true levels of circulating TxA2, a chemical that activates platelets and causes them to stick together.

“This patent further strengthens our strategic position in this important aspect of clinical testing,” said Douglass Simpson, Corgenix president and CEO. “By adding this patent to our already strong IP portfolio, Corgenix remains in a premier competitive position as this market continues to evolve.”

More than 1 million Americans experience new or recurrent heart attacks each year. At-risk individuals are eligible for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least 4 hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office or patient service center, making the test convenient for both physician and patient.

Source: Corgenix Medical

New Abbott HIV Test Can Detect HIV Days Earlier than Current US Tests

Abbott’s ARCHITECT HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.

“Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life-saving,” said Peter Leone, MD, medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill. “A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate.”

Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss up to 10% of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott’s new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

“Abbott has long been a pioneer in HIV testing—from the world’s first test to detect HIV antibodies in 1985—to second- and third-generation immunoassay and molecular tests—and now the development of the country’s first antigen and antibody combination test,” said Brian Blaser, senior vice president, Diagnostics, Abbott. “Abbott is committed to fighting HIV and to bringing novel tests to physicians in order to help patients get the care they need as soon as possible.” This new test will run on Abbott’s ARCHITECT family of diagnostic testing instruments. It is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.

Source: Abbott

ONC to Establish the Temporary Certification Program for EHR Technology

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Certification is used to provide assurance and confidence that a product or service will work as expected and will include the capabilities for which it was purchased. EHR technology certification does just that: It assures health care providers that the EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.

“By purchasing certified EHR technology, hospitals and eligible professionals and hospitals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system,” said David Blumenthal, MD, MPP, national coordinator for health information technology. “We hope that all HIT stakeholders view this rule as the federal government’s commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs.”

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the HITECH Act.

Source: HHS