In This Issue...

FDA Releases Draft Proposal on Health IT Product Oversight

Innovative health information technology (health IT) products present many potential benefits to patient care, such as preventing medical errors and reducing unnecessary tests. However, if these products are not designed, implemented, or maintained properly, they can also pose varying degrees of risk to the patients who use them. In order to protect patients while still promoting health IT product innovation, the Food and Drug Administration (FDA) has developed a draft report in consultation with the Department of Health and Human Services' Office of the National Coordinator for Health IT and the Federal Communications Commission that proposes to clarify oversight of health IT products.

The report, "Proposed Strategy and Recommendations for a Risk-Based Framework," proposes three health IT product categories based on a product's function and the level of risk it poses to patients. The first and second categories include, respectively, products with administrative health IT functions, such as billing and claims processing, and products with health management health IT functions, such as software for medication management. FDA does not propose to focus its oversight on these products, which it has determined pose low to no risk to patients. The third category, however, comprises products with medical device health IT functions, which, if they do not perform as intended, could pose greater risks to patients. The draft report proposes that FDA continue regulating these products, which include computer-aided detection software, software for bedside monitor alarms, and radiation treatment software.

FDA is seeking public comment on this draft document until July 7; electronic comments may be submitted at

In the coming weeks, the agency also plans to announce a 3-day public meeting to solicit comments on the draft report and gather feedback on the outlined strategy and approach.

Meridian Receives FDA Clearance for Molecular Whooping Cough Test

FDA has cleared Meridian Bioscience's test for Bordetella pertussis (B. pertussis), also known as whooping cough, the worldwide incidence of which has been increasing over the past 30 years. Designed for the illumigene platform, Meridian's test is the first FDA-cleared molecular stand-alone assay for this disease. According to the company, the current standard method for whooping cough diagnosis—B. pertussis bacterial culture—lacks sensitivity, and since many healthcare providers have to send out to reference laboratories for this test, they have to wait more than a week to get the results. By comparison, the illumigene Pertussis allows healthcare providers to collect and test samples in the same day, and provides results in less than 60 minutes by amplifying a specific DNA target for the detection of B. pertussis. This test is Meridian's fifth assay on the illumigene platform and uses nasopharyngeal swab samples.

Focus Gets FDA Nod for HSV Central Nervous Infection Assay

FDA has granted 510(k) clearance to Focus Diagnostics, a business of Quest Diagnostics, for its Simplexa HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler, in addition to categorizing the assay as CLIA moderate complexity. This is the first molecular test to receive FDA clearance for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid from patients suspected of HSV central nervous system infection, including encephalitis.

The Simplexa HSV 1 & 2 Direct employs real-time polymerase chain reaction technology in addition to a proprietary process that eliminates the nucleic acid extraction step used in most commercial molecular test kits. Nucleic acid extraction, according to Focus, requires specialized equipment and trained personnel, while also adding 60 to 90 minutes to the total time to result. By circumventing this step, the Simplexa HSV 1 & 2 Direct is able to provide results within about an hour. This also enabled FDA to categorize the test as moderate complexity, and broaden its availability to physician offices, community hospitals, health clinics, and integrated delivery networks that don't have the personnel and technology to perform high complexity molecular diagnostic tests.

FDA Clears Quidel HSV Test

Quidel Corporation has received FDA clearance for its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex virus 1 and 2. This is Quidel's third assay to launch in this hand-held, disposable format. Requiring no upfront DNA extraction, the test generates a result in approximately 1 hour. Like other AmpliVue assays, it also does not require thermocycling equipment.

FDA Advisory Committee Recommends Approval of Two Colon Cancer Tests

FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has voted unanimously for the approval of Exact Sciences' Cologuard, a stool-based DNA, non-invasive colorectal cancer screening test. All 10 panel members agreed that Exact Sciences has demonstrated the safety and effectiveness of Cologuard, as well as a favorable risk benefit profile. Data from the company's 10,000-patient trial factored prominently in the panel's decision. In this trial, which was one of the most extensive ever conducted in the U.S. for colorectal cancer screening, the Cologuard found 92.3% of colorectal cancer in average risk patients based on a combination of DNA and hemoglobin markers.

The Molecular and Clinical Genetics Panel also recommended approval of Epigenomics' blood-based colorectal cancer screening test, the Epi proColon, by a close vote of 5 to 4 (with one abstention). Epigenomics intends the Epi proColon to serve as a colorectal cancer screening alternative for patients currently not compliant with existing methods such as colonoscopy or stool-based tests, and the panel decided that the benefits of the Epi proColon outweigh the risks for use in patients who meet this criteria. However, the panel also expressed concerns about the lack of long-term data in a programmatic use of the product under the proposed intended use. To address these concerns, Epigenomics proposes a post-approval study that will assess the long-term benefits of colorectal cancer screening using the Epi proColon.

Overall, FDA is not bound by the recommendations of its advisory committees, but will consider this guidance as it evaluates these two tests.

Binding Site Receives Updated FDA Clearance for IgA Kappa/Lambda Assays

FDA has updated its clearance for The Binding Site's Hevylite IgA Kappa and IgA Lambda tests and expanded their intended use. The Hevylite assays are novel blood tests for the measurement of myeloma monoclonal immunoglobulins, and provide an alternative to classical assays for multiple myeloma that do not require serum protein electrophoresis, immunoelectrophoresis, or free light chain assay. The updated FDA clearance now specifically states that the tests can be used for monitoring previously diagnosed multiple myeloma patients.