Quest Diagnostics has received Food and Drug Administration emergency use authorization for a lab-developed molecular diagnostic test to aid in the diagnosis of monkeypox virus infection. Known as the Monkeypox Virus Qualitative Real-Time PCR assay, the test detects monkeypox virus DNA from the West African clade and clade II, as well as non-variola Orthopoxvirus DNA in lesion swab specimens stored in universal viral transport media.
A September 2 Centers for Disease Control and Prevention (CDC) Lab Alert calls for CDC to confirm monkeypox test results from public health labs for certain highly suspicious cases with negative results; this is due to a rare deletion in the tumor necrosis factor receptor gene of the virus. However, this alert does not apply to the Quest monkeypox test, the company said. In fact, Quest designed the test to detect both monkeypox virus and non-variola Orthopoxvirus DNA in order to help protect against false negatives.
Quest performs the test at its advanced laboratories in San Juan Capistrano, California, and Chantilly, Virginia. New York's Department of Health also has approved the tests from both laboratories, enabling access for patients living in the state.
COLLECTION TUBE FOR SARS-COV-2 TESTING RECEIVES 510(K) CLEARANCE AND CE MARK
MagBio Genomics recently announced Food and Drug Administration (FDA) 510(k) clearance and CE mark approval of its MagXtract Collection Tube, which is designed for sample collection and processing. According to the company, this is the first FDA-cleared collection tube with guanidine-free molecular transport medium that’s available for SARS-CoV-2 testing. It will enable laboratory staff to comply with FDA’s advisory to avoid collecting SARS-CoV-2 samples in devices that use guanidine-based mediums, because cleaning these devices with bleach creates the highly toxic gas cyanide. In Europe, the MagXtract Collection Tube is available for testing for both SARS-CoV-2 and influenza and is validated for bacterial and fungal sample collection, as well as stabilization in research studies. The tube’s medium directly lyses cells during transport and inactivates pathogens, eliminating the need for containment procedures. It also provides ambient temperature stability of RNA samples for up to 8 days, eliminating the need for cold storage and shipping.
ABBOTT’S TEST KIT FOR MONKEYPOX VIRUS GETS FDA EUA
The Food and Drug Administration (FDA) has granted emergency use authorization to Abbott Molecular’s Alinity m MPXV test for monkeypox virus. The test uses lesion swab specimens in viral transport media from individuals suspected of monkeypox infections and is intended for use by CLIA-certified laboratories.
Although positive results from this test are indicative of the presence of monkeypox virus, FDA requires clinical correlation with patient history and other diagnostic information to determine patient infection status. Likewise, positive results do not rule out bacterial infection or coinfection with other viruses. Negative results must also be combined with clinical observations, patient history, and epidemiological information.
FDA FINALIZES GUIDANCE ON CLINICAL DECISION SUPPORT SOFTWARE
The Food and Drug Administration (FDA) has issued final guidance indicating the types of clinical decision support (CDS) software functions that are considered medical devices under the new definition of a device established by the 21st Century Cures Act. The guidance also clarifies the scope of FDA’s oversight of CDS software intended for use as a medical device. It states that FDA's existing digital health policies continue to apply to software functions that meet the definition of a medical device, regardless of whether the software is intended for use by healthcare professionals or by patients and caregivers. The final guidance clarifies the types of CDS functions that do not meet the definition of a device, as well, and provides several related examples.
Additionally, it’s worth noting that a section on the International Medical Device Regulators Forum’s risk categorization that appeared in the 2019 draft version of this guidance is not included in the final version.
ROCHE GIVEN FDA CLEARANCE FOR SPACE-SAVING SYSTEM
The Food and Drug Administration has granted Roche 510(k) clearance for its cobas pure integrated solutions, which combines technologies for clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing on a single platform. With a footprint of about 21 square feet, the new compact, modular system is designed to help optimize space and resources for low- to mid-volume labs. The system also will provide access to a broad menu of more than 186 tests across a wide range of disease areas, including infectious diseases, oncology, and cardiology.
THERMO FISHER GETS FDA OK FOR CO-DIAGNOSTIC FOR CANCERS WITH RET MUTATIONS, FUSIONS
The Food and Drug Administration has approved Thermo Fisher Scientific’s Oncomine Dx Target test as a companion diagnostic to aid in the selection of patients who may be eligible for treatment with Lilly’s Retevmo (selpercatinib). Patients who might benefit from this drug include those with RET-fusion-positive locally advanced or metastatic non-small cell lung cancer, RET-fusion-positive advanced or metastatic thyroid cancer, and RET-mutation-positive advanced or metastatic medullary thyroid cancer.
The test is also approved in Japan as a companion diagnostic for Retevmo with the same indications. With these approvals, the test is now authorized for use as a companion diagnostic in 17 countries for 15 targeted therapies. Using next-generation sequencing, it detects multiple alterations at once from a small sample size, helping to quickly match patients with the appropriate targeted therapy.
QIAGEN ADDS NEW CE-MARKED ASSAYS TO NEUMODX INTEGRATED PCR SYSTEM
The CE mark has been granted to Qiagen’s new assays for Epstein-Barr virus (EBV) and human herpesvirus, which have been added to the company’s NeuMoDx assay menu for organ transplant-associated viruses. The new assays support Qiagen’s strategy of expanding the menu of tests available for use on the NeuMoDx 96 and 288 molecular systems.
The new tests are intended to aid in viral load monitoring in the management of immunocompromised patients, such as organ transplant patients. Diseases caused by EBV can cause major complications in organ transplant recipients. Herpesvirus infections also remain a major cause of postoperative mortality in transplant patients.