Regulatory Roundup

FDA Approves First Molecular Blood Type Test
The Food and Drug Administration (FDA) has approved the first molecular assay to assist in determining blood compatibility between transfusion recipients and blood donors. This assay, Immucor’s PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test, can be used to identify donor and patient non-ABO/non-RhD (non-ABO) red blood cell types.

ABO and RhD antigens are the two major categories of blood group antigens, but the surfaces of red blood cells also display minor blood group antigens in addition to these. If a transfusion patient develops antibodies to a non-ABO antigen, blood that is negative for this antigen must be found. Otherwise, the body will destroy red blood cells that express the antigen if they are transfused. The development of antibodies to non-ABO antigens can be prevented in the first place by selecting blood that is better matched to the patient’s non-ABO antigens.

Traditionally, serological typing has been used to identify red blood cell antigens and match patients with the appropriate donor blood. However, this method can’t be performed if antisera targeting the antigens of interest are scarce or unavailable. The Immucor PreciseType HEA Molecular BeadChip Test does not require antisera to identify antigens, and instead detects the genes that govern the expression of 36 non-ABO antigens. To accomplish this, the test uses thousands of coded beads that generate light signals upon binding with these genes. Accompanying computer software then decodes the light signals and reports which antigens are predicted to be present in a blood sample based on the genes that are detected.

Now that it has received FDA approval, Immucor’s test can serve as a new alternative to serological typing for determining non-ABO antigens on red blood cells.

First Non-Invasive Test to Identify Cause of Specific Kidney Disease Gets FDA Approval
FDA has approved Euroimmun’s Anti-PLA2R IFA blood test, making it the first non-invasive test that can help determine the cause of membranous glomerulonephritis (MGN), which is one of the leading causes of adult kidney disease. Some cases of MGN are associated with secondary conditions such as infections or tumors, adverse reactions to drugs, or poisoning. However, in about 85 percent of cases, MGN is an autoimmune condition, known as primary MGN (pMGN), in which the body rejects its own kidney tissue. Euroimmun’s test is able to differentiate between the two types of MGN by detecting an antibody that is specific to pMGN in a patient’s blood. In the clinical study conducted to review the Anti-PLA2R IFA test, it detected pMGN in 77 percent of samples obtained from patients presumed to have the disease. The test also gave a false positive result in less than 1 percent of samples from patients with other kidney diseases, including secondary MGN. The test should not be used alone to diagnose pMGN, though, and a kidney biopsy is still needed to confirm the diagnosis.

Beckman Coulter Receives CE Mark for Molecular Diagnostics Platform, CMV Assay
Beckman Coulter Diagnostics has obtained CE Mark approval for the Veris MDx system and Veris human cytomegalovirus (CMV) assay. The Veris MDx system is a fully automated, random access molecular diagnostics system for the quantitative and qualitative analysis of molecular targets from patient specimens. It integrates key steps in molecular diagnostics to streamline workflow and system management, while also ensuring prompt delivery of results for critical STAT samples. Other features that it provides include continuing access, one-step loading, and individual test reporting. The initial Veris menu includes the Veris CMV assay, which is a polymerase chain reaction test designed to measure CMV DNA in human plasma samples. When used in conjunction with clinical presentation and other laboratory findings, the Veris CMV assay aids in monitoring CMV viral load.

The Veris MDx system and accompanying CMV assay are not for sale or distribution in the U.S. and are not available in all markets.

Carolina Liquid Chemistries Receives FDA Clearance for High Volume Analyzer
Carolina Liquid Chemistries has received 510(k) clearance from FDA to market its new CLC6410 chemistry analyzer, which is designed to meet the high volume testing needs of large hospitals and clinical reference laboratories. The CLC6410 is modular, allowing laboratories to expand its throughput as their needs grow. The throughput of a single module is up to 1,600 tests/hour, while four modules can be joined to achieve a throughput of 6,400 tests/hour. Additionally, the new analyzer features other technological advances that save water and energy while automating many quality control procedures. The company will debut the new analyzer at the 2014 AACC Annual Meeting & Clinical Lab Expo in Chicago.

Corgenix, Randox Granted CE Mark for Aspirin-Response Test
Corgenix Medical Corporation and Randox Laboratories have received CE Mark approval for the TxBCardio assay, which they developed in collaboration. The TxBCardio test measures urinary levels of the thromboxane metabolite 11-dehydro thromboxane B2 (11dhTxB2) to determine the effect of aspirin in apparently healthy individuals. Aspirin can lower most individuals’ risk of heart attack, but 25% of people are resistant to its beneficial effects. Determining which patients do not respond to aspirin allows doctors to recommend alternative therapies for them.

The TxBCardio test is designed to extend the capabilities of Corgenix’s AspirinWorks ELISA assay, a simple urine test that also measures 11dhTxB2. With its immunoturbidimetric assay format, TxBCardio will enable testing for this thromboxane metabolite to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals.

The safety and efficacy of the TxBCardio assay has not yet been evaluated by FDA and is not cleared for clinical diagnostic use in the United States.  

BD Max Garners FDA Clearance for Bacterial Gastroenteritis Panel
FDA has granted 510(k) clearance to BD Diagnostics for its BD Max Enteric Bacterial Panel for use on the BD Max System. This panel is a qualitative test that detects DNA from the pathogens responsible for 95% of bacterial gastroenteritis: Campylobacter spp. (jejuni and coli), Salmonella spp., Shigella spp./enteroinvasive Escherichia coli, Shiga toxin-producing E. coli (STEC), and Shigella dysenteriae, which can possess a Shiga toxin gene that is identical to one found in STEC. The BD Max panel is designed to detect bacterial pathogens in line with widely recommended clinical algorithms for testing, which use patient history and clinical presentation in selecting diagnostic tests. It produces results in approximately 3 hours, and can be performed using unpreserved and Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis.

Additionally, labs can use this panel to implement the STEC screening recommended by the Centers for Disease Control and Prevention and required by the Joint Commission.

Quidel Gets FDA Nod for HSV/VZV Assay
FDA has cleared Quidel’s Lyra Direct HSV 1+2/VZV multiplex real-time polymerase chain reaction (PCR) assay. This new molecular test detects and differentiates between herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV). It accomplishes this by identifying viral nucleic acids that have been isolated and purified from swab specimens of skin, mouth, lip, or genital lesions on symptomatic patients. As part of Quidel’s new Lyra brand of ready-to-use molecular PCR reagent kits, this assay is designed to be compatible with a laboratory’s existing thermocycler, and provides ready-to-use master mix as well as key reagents that can be refrigerated instead of frozen. The Lyra Direct HSV 1+2/VZV assay also offers an extraction-free, three-step sample preparation process. This direct-to-amplification procedure allows the test to generate a result in approximately 50 minutes.

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