The diagnostics space just had a pretty significant week. From strong data to key product launches, the space saw a substantial amount of activity. It could be argued the spike in activity and timing of some of the announcements was spurred on by the reveal of a newly-formed task force comprised of FDA, Centers for Disease and Control, and the Centers for Medicare and Medicaid Services. The goal of the task force is to help make diagnostics rapidly available during public health emergencies.
T2 Biosystems was the latest to make waves in the industry with news that it had obtained “Breakthrough Device” designation for its T2Resistance Panel. The Lexington, MA-based company’s diagnostic panel can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture.
Several of the genes detected by the panel are listed on the CDC’s Urgent Threatlist for antibiotic resistance.
“The T2ResistancePanel is similar to our other tests, the T2Bacteria Panel and the T2Candida Panel,” Tom Lowery, Phd, CSO of T2 Biosystems, told MD+DI. “All are operated on the T2Dx instrument powered by T2 Magnetic Resonance Technology (T2MR), and the key is that these tests are performed directly from unprocessed blood, without the need or wait for blood culture. As a result of this method, the T2Resistance panel can identify the most prevalent resistance markers in three to five hours instead of days so clinicians can make fast, informed decisions for their patients and improve patient outcomes.”
Abbott Laboratories caused some excitement when it said its latest rapid influenza diagnostic test has been granted waived status under CLIA by FDA. The Abbott Park, IL-based company said its BiaxNow Influenza A&B Card 2 is for use with the Digival diagnostic reader (formerly Alere Reader).
Influenza is highly infectious virus,” Dr. Norman Moore, Director of Scientific Affairs, Infectious Disease at Abbot, told MD+DI. “Potentially infectious patients should not be waiting in a facility for a test result, putting other vulnerable patients or medical staff at risk. It is important to see them as soon as possible and direct the appropriate therapy. With the BinaxNOW Influenza A & B Card 2 assay and Digival reader, medical professionals don’t need to make that choice anymore as they can get rapid, accurate and automated results while the patient is in the office with a test that is simple enough to be CLIA-waived.”
Another development in the field came from Guardant Health. The Redwood City, CA-based company said there were positive results from the NILE study. This was a head-to-head comparison of the Guardant360 assay to standard-of-care tissue testing for the identification of guideline-recommended biomarkers in first-line advanced non-small cell lung cancer (NSCLC) patients.
Findings from NILE show that Guardant360 identified guideline recommended-biomarkers in 77 patients; tissue testing identified them in 60. Importantly, for each patient in whom Guardant360 identified a target of an FDA-approved drug (EGFR, ALK, BRAF, ROS1), tissue also detected the same alteration. Additionally, the median time to results for Guardant360 was much shorter than for tissue testing. Guardant360 results were reported in an average of 9 days, vs. 15 days for tissue. The NILE study met its primary endpoint of demonstrating comparable performance of Guardant360 to tissue.
At the Heart of the Matter
So why is it such a busy time in diagnostics? It goes back to the announcement of the Tri-Agency task force. Not only does it show agencies taking the initiative to work closely with the industry, but it also provides much-needed clarity.
rior to this partnership, feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an Emergency Use Authorization; particularly, the community was uncertain about meeting CLIA regulations under an EUA to allow labs to start testing specimens.
“During public health emergencies, ensuring the health and safety of patients through quality laboratory testing will remain the focus of CMS,” said Kate Goodrich, director of the Center for Clinical Standards and Quality and CMS Chief Medical Officer. “Timely implementation of EUA diagnostic assays in the US healthcare system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing. As part of this task force, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”
By standardizing collaboration efforts, the federal partners hope to address issues related to implementation of diagnostic tests authorized for emergency use under an EUA, as well as other unmet needs and gaps in preparing and responding to global health threats. The task force will provide a forum for each agency to coordinate, provide consultation, and improve the availability of diagnostic tests during public health emergencies. In addition, to assist in public health preparedness, the task force will work to define, refine and streamline interagency approaches for the implementation of EUA diagnostic tests. The hope is that the task force will enable an even more efficient federal government response for making diagnostic tests available in the event of a public health emergency.
“Public health emergencies, like Ebola outbreaks, remind us that we’re a global community when it comes to public health protection,” Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, said in a release. “Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response. We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination. This task force will help our agencies better collaborate to prepare for, and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field.”