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FDA approves blood glucose monitoring system

The FDA has approved Intuity Medical's (Sunnyvale, Calif.) POGO Automatic Blood Glucose Monitoring System, the first blood glucose meter and multitest cartridge to provide automatic testing with lancing, blood collection, and analysis in one easy step. POGO combines all necessary blood glucose testing supplies into a convenient, self-contained, 10-test cartridge, providing ease of use and discretion for patients who need to regularly test their blood glucose to manage diabetes mellitus. Patients no longer need to carry and use separate test supplies and can perform a quick and discreet glucose test while on the go.


To perform a test, the patient places the finger on the port and presses the POGO test port, and POGO automatically lances the finger, collects a blood sample, and displays a result after a 4-second countdown. The meter requires only a tiny blood sample of 0.25 mcL to analyze the glucose value. After all 10 tests are complete, the patient disposes the self-contained cartridge, eliminating the need to handle used test strips or lancets because they remain behind in the cartridge.

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POGO can be combined with the company's proprietary Patterns Diabetes Management application, a secure cloud-based system for managing glucose information that provides patients and healthcare professionals with a comprehensive shared platform to detect and manage important patterns and trends that affect overall glucose control.


First blood-based colorectal cancer screening test approved

Epigenomics AG (Germantown, Md.) has received FDA approval of Epi proColon, the first blood-based colorectal cancer (CRC) screening test. The qualitative in vitro polymerase chain reaction assay detects methylated Septin9 DNA, a biomarker for the SEPT9 gene, which is increased in CRC. The test can be performed during routine office visits and requires no dietary restrictions or alterations in medication use.


The test is approved for CRC screening in adults of either gender, age 50 or older, who are defined (by current screening guidelines) as at average risk for CRC and who have been offered and have not completed CRC screening by a stool-based fecal immunochemical test or colonoscopy. The test should be used in combination with a health practitioner's assessment and individual risk factors in guiding patient management. Patients with a positive test result should be referred for diagnostic colonoscopy.


Epi proColon was approved on the basis of the results of three clinical studies and its potential to significantly increase participation rates in CRC screening. According to Epigenomics, the company will conduct a post-approval study to demonstrate the long-term benefit of blood-based colorectal cancer screening using Epi proColon.


Zika virus test authorized for emergency use

The FDA has authorized emergency use of Quest Diagnostics' (Madison, N.J.) Zika Virus RNA Qualitative Real-Time RT-PCR Test. The test is intended for the qualitative detection of Zika virus RNA in human serum specimens. It is the first test from a commercial lab to be granted an emergency use authorization for testing patients for Zika virus RNA. Previously, the only Zika virus test authorized by the FDA was available from the CDC.


The approval broadens access to a diagnostic tool for managing the Zika virus outbreak, according to Quest, and can influence the quality of patient management. The test can potentially be performed at any Clinical Laboratory Improvement Amendments high-complexity lab in the Quest Diagnostics network, which includes several dozen labs in the United States (including one in Puerto Rico). For now, only the company's Focus Diagnostics reference lab in San Juan Capistrano, Calif., will perform the test.