Test identifies five yeast pathogens
T2 Biosystems (Lexington, Mass.) has received FDA approval for the T2Candida Panel and T2Dx Instrument to identify five common yeast pathogens that can cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata, and/or Candida krusei. The test can be performed from a single blood specimen within 3 to 5 hours. The test is the first direct blood test for these pathogens approved in the United States.
The FDA based its approval on a clinical study of 1,500 patients in which the test correctly categorized nearly 100% of the negative specimens as negative for the presence of yeast. T2Candida correctly identified the organism in 84% to 96% of positive specimens in a separate test of 300 blood samples with specific concentrations of yeast.
Cologuard approved for rectal cancer screening
Exact Sciences Corp. (Madison, Wis.) has been granted FDA approval for Cologuard, a stool-based colorectal cancer (CRC) in-vitro diagnostic device. The test was approved as an adjunctive screening test to detect colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool.
The device is not meant to replace colonoscopy; it is intended to be used in conjunction with colonoscopy and other test methods recognized in screening guidelines. Cologuard offers another option to screen for CRC and is able to detect more cancers than other fecal occult tests.
The safety and effectiveness of the new test was shown in a large clinical trial screening over 10,000 patients. Cologuard detected 92% of CRCs and 42% of advanced adenomas compared with a fecal immunochemical test (FIT), which detected 74% of cancers and 24% of advanced adenomas. Cologuard was less accurate than FIT at correctly identifying patients who were negative for CRC or advanced adenomas.
Autoantibody test for type 1 diabetes approved
Kronus's Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay (Star, Idaho) was approved to help diagnose type 1 diabetes. The test may help some patients with type 1 diabetes receive a timely diagnosis and treatment for the disease when used with other tests and clinical information.
The test detects the presence of the ZnT8Ab autoantibody that is produced by many patients with type 1 diabetes but not by those with type 2 or gestational diabetes.
The assay was approved based on data from a clinical study of 569 blood samples from patients with type 1 diabetes as well as from patients with other types of diabetes, autoimmune diseases, or other conditions. The test was able to detect the ZnT8 autoantibody in 65% of samples from patients diagnosed with type 1 diabetes; incorrect positive results occurred in fewer than 2% of samples from patients diagnosed with other diseases.
Negative results from the test do not rule out type 1 diabetes.
Glucometer system with built-in insulin calculator
Roche's Accu-Chek Aviva Expert blood glucose meter system (Indianapolis, Ind.) was approved by the FDA for patients with diabetes who take multiple daily insulin injections. The meter's integrated bolus calculator provides easy-to-use and reliable dose recommendations based on automated calculations, eliminating the need for manual dosing calculations and estimations. The system is available by prescription for patients with diabetes who are trained in multiple daily insulin injection therapy and are under the care of healthcare professionals experienced in managing insulin-treated patients.
The system includes the meter, test strips, the Bolus Advisor (used to provide insulin dose recommendations in response to blood glucose, health events, and carbohydrate input), and control solutions.