Quest Diagnostics said this week that its Focus Diagnostics business has received expedited 510(k) clearance from the US Food and Drug Administration and CLIA moderate complexity categorization for its Simplexa HSV 1&2 Direct molecular test on the 3M Integrated Cycler.
Quest said the test is the first molecular assay cleared by FDA for the qualitative detection and characterization of herpes simplex virus 1 and HSV 2 in cerebrospinal fluid from patients who are suspected of having HSV central nervous system infection.
Using a proprietary chemistry, the test eliminates the need for nucleic acid extraction, reducing costs and the time to result to about an hour, Quest said.
Moderate complexity categorization of the test, Quest added, expands clinical access to the technology, as the categorization means certain laboratories, as defined by CLIA, can use the test. Such labs typically don't have the personnel and technology to perform high-complexity molecular diagnostic tests, and include those in physician offices, community hospitals, health clinics, and integrated delivery networks.
Simplexa tests are designed to run on the 3M Integrated Cycler, and use real-time PCR technology. Simplexa HSV 1&2 was CE marked in November 2013.
At the Association for Molecular Pathology meeting in December, Amy Leber of the Department of Laboratory Medicine at Nationwide Children's Hospital — one of the clinical trial sites for the assay — presented data from her lab's trial. Leber noted during her talk that, in 228 CSF samples from neonatal patients with signs and symptoms of CNS disease, Simplexa HSV 1&2 had positive predictive values of 78.9 percent for HSV I and 75 percent for HSV 2, and a negative predictive value of 100 percent for both.
IMDx said today that its IMDx VanR assay for the Abbott m2000 platform has received regulatory clearance from Health Canada and Singapore's Health Sciences Authority, allowing the test to be sold and distributed in those countries.
The assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. It is intended to be used as an aid to identify, prevent, and control vancomycin-resistant colonization in healthcare settings.
The test was previously cleared by the US Food and Drug Administration and has received CE marking.
IMDx said that it has also initiated development of the IMDx EBV for Abbott m2000 assay, a test for the quantitative measurement of Epstein-Barr virus DNA in human whole blood or plasma specimens in order to aid in monitoring viral response to antiviral treatment or immunosuppressive therapy.
Transplant patients with elevated EBV levels are at high risk for severe and potentially fatal complications, making monitoring of viral load critical post-transplantation. IMDx will seek CE-marking for the EBV test, which would make it the sixth test in the company's portfolio of CE-marked tests that runs on Abbott's m2000 system.
"Our collaboration with Abbott has been very rewarding, with the global introduction of five CE-marked products and three FDA-cleared products," IMDx CEO Alice Jacobs Nesselrodt said in a statement. "We are looking forward to further expanding our product offerings in Canada and parts of Asia-Pacific and to broadening our test menu with the development of the EBV test."
Meridian Bioscience said today that it has received US Food and Drug Administration clearance for its Illumigene Bordetella pertussis molecular diagnostic test.
Illumigene Pertussis test is the fifth assay on Meridian's Illumigene platform, which is based on loop-mediated isothermal amplification. The test amplifies a specific DNA target to detect B. pertussis, providing a definitive result and helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner, the company said.
The test uses nasopharyngeal swab samples and takes less than sixty minutes to report a result. It requires no expensive capital equipment, and no costly annual service contracts, Meridian said.
Often referred to as "whooping cough", B. pertussis can cause serious illness in infants, children, and adults. The worldwide incidence of pertussis has been on the increase over the past 30 years. Each year, there are approximately 16 million reported cases of pertussis and nearly 200,000 deaths. In the US alone, more than 48,000 pertussis infections were reported in 2012 — the highest number of cases reported in the country since 1955.
"Although whooping cough is said to be on the rise, Bordetella pertussis is under-diagnosed and under-reported," Meridian CEO John Kraeutler said in a statement. "Currently hospital laboratories are performing bacterial culture; however, most labs are sending out for a pertussis diagnosis; both scenarios can take over a week to report a final result, increasing the time to manage the patient appropriately. With Illumigene Pertussis, healthcare providers can collect, test, and treat same day for optimal patient management."
Meridian said that the assay will be available for market within 30 days.
DermTech International said this week that it has completed California CLIA licensure of its San Diego laboratory facility.
The company also said that it has completed validation testing of its proprietary Pigmented Lesion Assay (PLA), which it plans to offer as a laboratory-developed test out of its CLIA lab. The company's assays analyze the expression level of multiple gene targets using Thermo Fisher Scientific's Life Technologies OpenArray quantitative real-time PCR system.
DermTech's PLA gauges expression of two genes associated with melanoma and can be used on samples collected with an adhesive patch rather than a scalpel. The information can be used to help clinicians non-invasively assess the need for a surgical biopsy and to support pathological diagnosis.
DermTech and collaborators elucidated the performance of PLA in a series of three studies examining 288 lesions from more than 140 melanomas. In two validation studies comparing the two-gene expression profile to histopathology diagnosis, the PLA demonstrated 91 percent accuracy in identifying non-melanoma and melanoma lesions, with a sensitivity of 93 percent and a specificity of 90 percent. Studies have shown that the current standard clinical assessment of pigmented lesions demonstrates an accuracy of less than 20 percent with sensitivities ranging from 70 to 80 percent and specificities ranging from 5 to 20 percent, the company said.