Thyroid Cancer Mutation Panel
Identify mutations associated with four gene markers
Quest Diagnostics, introduces a molecular test panel designed to help physicians determine if a thyroid gland is cancerous and requires surgical removal. Quest says the test is believed to be the most comprehensive panel clinically available to identify mutations associated with four gene markers indicated by the American Thyroid Association for the clinical management of indeterminate thyroid biopsies. The Quest Diagnostics Thyroid Cancer Mutation Panel aids in detecting cancer in thyroid biopsies, which are found to be indeterminate for cancer by current cytology test methods. The new panel identifies mutations of the molecular markers BRAF V600E, RAS, RET/PTC, and PAX8/PPAR gamma, which are associated with papillary and follicular thyroid cancer, two common forms of the disease. Richard E. Reitz, MD, Quest Diagnostics' endocrine chair and medical director (pictured), is one of the developers of the molecular thyroid testing service.
MRSA Molecular Test
Identify patients colonized with MRSA
BD Diagnostics, Franklin Lakes, NJ, a segment of BD, has received FDA clearance to market the BD MAX™ MRSA molecular test in the United States. The assay is performed on the fully automated BD MAX System, and is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). Rapidly and accurately identifying patients enables infection-control measures to be implemented faster to reduce transmission, and help prevent infection in vulnerable patients. The BD MAX MRSA assay is the second test cleared this year by the FDA on the BD MAX System. This milestone confirms BD’s commitment to rapidly expand its menu, enabling laboratories to offer a broad range of molecular tests that meet their current and future clinical needs.
Hepatitis C Assay
High sensitivity and specificity
Siemens Healthcare Diagnostics, Tarrytown, NY, introduces its Enzygnost Anti-HCV 4.0 Assay, a hepatitis C laboratory test with high sensitivity and specificity that completes the company’s integrated infectious disease screening panel for blood banks. The sensitivity and specificity of the new Enzygnost Anti-HCV 4.0 assay, which can produce a test result 30 minutes to 1 hour faster than competing HCV assays in the microtitration plate (MTP) format, the company says, helps reduce the number of false-positive results obtained to fewer than one in 1,000 anti-HCV-negative sera. Combined, the assay’s sensitivity and specificity supports several important benefits, including fewer blood donor deferrals, more donations added to the blood supply, fewer costly reruns and PCR/NAAT testing, and earlier treatment options for donors who test positive, improving patient care. The Anti-HCV 4.0 Assay kit, like all tests in Siemens’ Enzygnost panel, comes complete with a bar code labeling system, making identification of all MTPs, conjugates, substrates, and controls automatic, accurate, and easy.
Siemens Healthcare Diagnostics