FDA Clears SQI Diagnostics Celiac Panel

SQI Diagnostics has received clearance from the Food and Drug Administration (FDA) for its Ig_plex Celiac DGP panel as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. Celiac disease is an autoimmune disorder in which an inappropriate immune response to gluten damages the absorptive surface of the small intestine, resulting in an inability of the body to absorb necessary nutrients. According to a study published in the New England Journal of Medicine, it affects an estimated 1 in 100 people in the U.S. Research published in the American Journal of Gastroenterology has also reported that as many as 97% of celiac patients could be undiagnosed, highlighting a need for improved tests.

The SQI celiac panel is designed for the semi-quantitative detection in blood of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG)—autoantibodies produced as part of the body’s immune response to gluten. The test also requires the use of SQI’s sqid-X system. Both the American College of Gastroenterology and the American Gastroenterology Association recommend that healthcare providers use assays for anti-tTG and anti-DPG as a part of routine testing for celiac disease. Testing for the IgA class of anti-tTG is the most sensitive and specific non-invasive method for celiac disease screening, while tests for the IgA or IgG class of anti-DGP may be positive in some people with celiac disease who are negative for anti-tTG, especially children younger than 2 years old.

Sixth Ebola Test Authorized for Emergency Use by FDA

FDA has issued an emergency use authorization (EUA) to green-light the use of Altona Diagnostics’ RealStar Ebolavirus RT-PCR Kit 1.0 for the diagnosis of Ebola. This is the sixth Ebola test that FDA has authorized for emergency use since Secretary of Health and Human Services Sylvia Burwell declared that the West African Ebola outbreak justifies the emergency use of in vitro diagnostics for detection of the virus. The RealStar Ebolavirus kit differs from the previous five tests to receive emergency use authorization in that it can detect RNA from several different species of Ebola in addition to Zaire ebolavirus, which is the cause of the current outbreak. The other Ebola species that this kit detects include Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus. The kit does not distinguish between the different species or strains, however. Under the terms of the EUA, this test can only be used on specified instruments by CLIA high complexity laboratories.

FDA Releases Guidance on Molecular Diagnostics Instruments with Combined Functions

FDA announced the availability of the guidance, “Molecular Diagnostic Instruments With Combined Functions,” which details the agency’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required. Molecular diagnostic instruments such as real-time thermocyclers are often used to perform multiple unrelated assays, such as those that detect methicillin resistant Staphylococcus aureus, hepatitis C virus, and genetic markers of cystic fibrosis. These types of instruments cannot generally be approved or cleared without an accompanying assay, because their safety and effectiveness cannot be evaluated without reference to the defined performance parameters of the tests they run. However, the same instruments may also be used for additional purposes that do not require FDA approval or clearance, such as basic scientific research.

In the past, FDA has provided informal advice in response to individual inquiries regarding the permissibility of having functions for which approval/clearance is not required on an instrument intended for use with approved/cleared diagnostic assays. This guidance is meant to officially lay out FDA’s policy regarding these types of instruments. It also outlines what information FDA recommends applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.

CMS Seeks to Clarify That Automated Fecal Occult Blood Tests Are Not Waived

The Centers for Medicare and Medicaid Services (CMS) has proposed amending the CLIA regulations to clarify that the waived test categorization for fecal occult blood tests applies only to the non-automated version of these tests. Fecal occult blood is one of the original eight waived tests published in the Federal Register in 1992. At the time the regulation was adopted, fecal occult blood was a manual test method. Since then, however, automated fecal occult blood analyzers have been developed that use complex and sophisticated technology and do not meet the CLIA criteria for waiver. It is important to clarify that these tests are not included in the list of tests waived in the CLIA regulations, and CMS proposes revising the current regulation to specify that only non-automated fecal occult blood tests are automatically waived.

Furthermore, since the development and proliferation of the waived test for hemoglobin by single analyte instruments with self-contained or component features, CMS has come to the understanding that the non-automated hemoglobin by copper sulfate method may no longer be in use. If comments support this conclusion, CMS proposes removing this test from the list of waived tests.

CMS is seeking public comment on this proposal through January 6. Electronic comments may be submitted at www.regulations.gov.

FDA Gives Nod to Roche’s Molecular Point-of-Care Strep A Test

Roche has earned 510(k) clearance for the cobas Strep A test for the detection of group A streptococcus bacterial (strep A) DNA in throat swab specimens. The cobas Strep A offers a time to result of 15 minutes, versus conventional methods such as culture testing, which can take up to 2 days to produce results, or rapid antigen testing, which still requires confirmation with culture due to lower sensitivity. Additionally, the test uses polymerase chain reaction technology and runs on the cobas Liat System, a molecular point-of-care diagnostic instrument that will be launched later this year. The cobas Liat analyzer is designed for on-demand testing in physician clinics, pharmacy, and hospital lab settings, and will include the cobas Influenza A/B test in addition to the cobas Strep A.