CLN Article

News From the FDA

In This Issue...

FDA Announces Meeting to Vote on Premarket Approval for Roche HPV Test

The U.S. Food and Drug Administration (FDA) has announced an upcoming meeting of the Medical Devices Advisory Committee';s Microbiology Devices Panel that will be open to the public. At this meeting, the committee will discuss, make recommendations, and vote on a premarket approval application from Roche Molecular Systems for a new indication for the cobas human papillomavirus (HPV) test. The cobas HPV test qualitatively detects 14 high risk HPV types in a single analysis, with a specific focus on HPV genotypes 16 and 18. The test accomplishes this by amplifying target DNA through polymerase chain reaction and nucleic acid hybridization.

Currently, the cobas HPV test is approved for use in conjunction with cervical cytology. Roche';s new application seeks to have the test approved for use as a first-line primary cervical screening test as well. Per the proposed indication, women who test negative for high risk HPV types by the cobas HPV test would undergo follow up in accordance with a physician';s assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV 16 and/or 18 would be referred to colposcopy. Additionally, women who test negative for 16/18 but positive for any of the other 12 high risk HPV types would be evaluated by cervical cytology to determine the need for referral to colposcopy.

This meeting of the Medical Devices Advisory Committee will take place on March 12 in College Park, Md. Interested persons may submit data, information, or views on the cobas HPV test in writing on or before March 3.

To make a submission and/or for more information, please contact Shanika Craig of the Center for Devices and Radiological Health at [email protected].

FDA Announces Meeting to Vote on Premarket Approval of Epigenomics, Exact Sciences Colon Cancer Tests

In late March, the Medical Devices Advisory Committee';s Molecular and Clinical Genetics Panel will hold a 2-day public meeting to discuss, make recommendations, and vote on information related to Epigenomics'; premarket approval application for the Epi proColon and Exact Sciences'; premarket approval application for the Cologuard device.

The Epi proColon test is designed to screen for colorectal cancer (CRC) in patients who are at average risk for developing it. Using plasma derived from whole blood samples, the test detects methylated Septin 9 DNA, which is associated with the occurrence of CRC. The Epi proColon test is not intended to replace colorectal screening by colonoscopy, however, and patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy.

Cologuard is also indicated for CRC screening, as well as premalignant colorectal neoplasia screening. It analyzes patients'; stool for the presence of occult hemoglobin, multiple DNA methylation and mutational markers associated with colorectal neoplasia, and the total amount of human DNA. Like the Epi proColon test, Cologuard should be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

This meeting of the Medical Devices Advisory Committee will take place in Gaithersburg, Md. and will address the Epi proColon test on March 26 and the Cologuard device on March 27. Interested persons may present data, information, or views, orally or in writing, on both of these tests. Requests to make an oral presentation may be submitted on or before March 10, while written submissions will be accepted on or before March 17.

To make an oral presentation request, a submission, and/or for more information, please contact Jamie Waterhouse of the Center for Devices and Radiological Health at [email protected].

John Cunningham Virus Serological Reagents Reclassified as Class II (Special Controls)

FDA has issued a final order changing the classification of John Cunningham Virus (JCV) serological reagents from class III to class II (special controls). By identifying JCV antibodies in patient serum and plasma, these reagents aid in the risk stratification for the development of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis and Crohn';s disease patients undergoing natalizumab therapy. Under this new classification, devices using these reagents will be subject to less stringent regulatory control, though they will not be exempt from premarket notification requirements. Additionally, FDA believes that the measures set forth in ";Class II Special Controls Guideline: John Cunningham Virus Serological Reagents"; are necessary, in addition to general controls, to reduce problems such as false-positive or false-negative test results that could potentially harm patient health. Following this final classification order, any firm submitting a 510(k) premarket notification for this device type will need to comply with the special controls.

FDA Approves First Continuous Glucose Monitoring System for Children

FDA announced approval for the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. Continuous glucose monitors (CGM) use small sensors inserted just under the skin and provide a steady stream of information about glucose levels in interstitial fluid. When used along with blood glucose meters, CGMs can help people with diabetes detect when blood glucose values are approaching dangerously high or dangerously low levels. The devices require a prescription and are meant to complement, not replace, information obtained from standard home glucose monitoring devices.

In a statement, FDA noted that the agency has not approved the use of CGM values alone to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions such as insulin dosing should be based on readings from a blood glucose meter.

"This device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Devices in FDA';s Center for Devices and Radiological Health. "This approval for expanded use is part of the FDA';s work to meet the needs of children living with diabetes."

Before the approval, FDA reviewed data from a pivotal clinical study of in-clinic and home-use patients to assess the accuracy and precision of the system. The study demonstrated that the G4 Platinum (Pediatric) System performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the performance of the hypoglycemic detection alert in the pediatric study was poor relative to that seen in the adult study, particularly at blood glucose concentrations <70 mg/dL. Despite these limitations, the study demonstrated that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially hyperglycemic or hypoglycemic levels.

To communicate the reduced accuracy in pediatric patients to users, two warnings are included in the labeling, and are displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed.