CLN Article

News From the FDA

In This Issue...

Roche's HPV Test First Ever Approved for Primary Cervical Cancer Screening

FDA has expanded upon its 2011 approval of Roche's cobas human papillomavirus (HPV) test, making it the first HPV DNA test that can be used by itself to help healthcare professionals assess the need for a woman to undergo additional screening for cervical cancer. The test can also provide information about a patient's risk of developing cervical cancer in the future. Originally approved for use in conjunction with or as a follow-up to a Pap test, the cobas HPV test is for women age 25 and older. Using a sample of cervical cells, it detects DNA from 14 high-risk HPV types, specifically identifying HPV 16 and 18 while concurrently detecting 12 other types of high-risk HPVs. Women who test positive for HPV 16 or 18 should then have a colposcopy. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Healthcare professionals should use the cobas HPV test results together with other information, such as the patient's screening history and risk factors, and current professional guidelines.

FDA Warns Against Use of Unproven GenStrip Blood Glucose Test Strips

FDA advises both diabetics and healthcare professionals to stop using Shasta Technologies' GenStrip Blood Glucose Test Strips, which are advertised for use with the LifeScan OneTouch family of glucose meters in the home and in healthcare facilities. During a recent inspection of Shasta documented in an April 2014 warning letter, FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. Without assurance of an adequate quality system, FDA believes that the strips could report incorrect blood glucose levels, which could lead to inappropriate or delayed treatment that could significantly harm patients. To date, Shasta Technologies has been unwilling to recall their test strips. As a result, FDA urges patients and healthcare providers to start using alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.

Draft Guidance Aims to Expedite Approval of Medical Devices That Address Unmet Needs

FDA has released two draft guidance documents aimed at striking a balance between ensuring the safety and efficacy of medical devices while still providing timely patient access to breakthrough technology.

The first document, "Expedited Access for Premarket Approval (EAP) Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions," proposes a new program to provide earlier access to high-risk medical devices designed to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology. While the EAP program is not a new pathway to market, it aims to reduce the time for premarket review and product development by offering medical device manufacturers the chance for earlier and more collaboration with FDA staff during the approval process.

To be eligible for participation in the program, a medical device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition for which either no approved alternative treatment or diagnostic exists, the new technology provides a clinically meaningful advantage over existing technology, or availability of the new technology is in the patient's best interest.

In addition to the EAP draft guidance, FDA published the document, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval." This draft guidance outlines the agency's current policy on when data can be collected after product approval and what actions are available to FDA if approval conditions, such as postmarket data collection, are not met.

FDA is seeking public comments on both documents through June 22. Electronic comments may be submitted at

New FDA-Cleared Vitamin D Assay Now Available on CLC720 Platform

Carolina Liquid Chemistries announced the availability of a new, FDA-cleared vitamin D assay on the company's CLC720 general chemistry analyzer. Known as the Vitamin D-direct assay, this test is a homogenous immunoassay that measures true total 25-hydroxy vitamin D, which is the sum of D3 + D2. The test can produce a result without a technologist having to manually pre-treat the specimen or the reagent. The CLC720 can also run up to 400 vitamin D tests per hour, and can be run in random access mode with other chemistry tests, eliminating the need for batch testing. These two features combined reduce the time-to-result to less than 20 minutes from the 2 to 7 hours that microtiter plate vitamin D tests require. Additionally, the Vitamin D-direct assay offers a wide dynamic range with improved precision, and eliminates washing steps as well as inaccurate results caused by matrix effects.

Randox Receives Clearance for Four Clinical Controls

FDA has cleared four different Randox controls: the company's Acusera HbA1c quality control, Acusera Aldolase and Ammonia Ethanol clinical chemistry controls, and immunology cerebrospinal fluid (CSF) control.

Acusera HbA1c is used to ensure accuracy in the diagnosis and ongoing monitoring of diabetes. It is lyophilized to enhance stability and longevity, with assayed values provided for high-performance liquid chromotography as well as a wide range of clinical chemistry analyzers. Additionally, it is a 100% human whole blood control, which helps minimize matrix effects and reduces lot-to-lot variations between batches.

Randox's Acusera Aldolase calibrator and controls can be used when testing for liver damage as well as skeletal muscle diseases such as muscular dystrophy, while Randox Ammonia Ethanol control is liquid ready to use, with an open vial stability of 30 days at 2–8°C.

Lastly, Randox's immunology CSF control is a multi-analyte CSF control that is suitable for use on most clinical analyzers, providing method-specific target values and ranges for 11 analytes.

510(k) Clearance for BioFire's Gastrointestinal Panel

BioFire, a molecular biology affiliate of bioMérieux, has received 510(k) clearance for the FilmArray gastrointestinal (GI) panel. This panel contains 22 bacterial, viral, and parasite targets in one test—including several for which there were no FDA-cleared tests prior to this—thereby covering the breadth of pathogens that cause GI illness. Unlike open-platform testing that leaves labs vulnerable to cross-contamination, the FilmArray is also a closed system that integrates sample preparation, amplification, and detection. This panel is performed directly from stool in Cary Blair transport media, takes 2 minutes to set up, and produces results in about 1 hour.