The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. Developed by GenScript, the test is called the cPass SARS-CoV-2 Neutralization Antibody Detection kit. Neutralizing antibodies are those that have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. FDA has previously issued EUAs for more than 50 antibody tests, but these other tests only detect the presence of binding antibodies, which target SARS-CoV-2 without necessarily decreasing the infection and destruction of host cells.

It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched. The ability to detect these antibodies with GenScript’s test could help researchers gain additional insight into what the existence of neutralizing antibodies tells us about a patient’s potential immunity. However, FDA cautions patients against using the results from this test—or any serology test—as an indication that they can stop social distancing, wearing a mask, or other steps to protect themselves and others. Like other serology tests, GenScript’s test also cannot be used to diagnose an active infection.

FDA Releases List of Essential Medicines and Medical Countermeasures

In response to an August 6, 2020 executive order, the Food and Drug Administration has identified and published a list of essential medicines, medical countermeasures, and critical inputs deemed medically necessary to have available at all times in an amount adequate to serve patient needs. This list includes diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, and devices for managing acute illnesses such as ventilators. The list also includes medicines that are most needed for patients in U.S. acute care medical facilities and active pharmaceutical ingredients of essential medicines and medical countermeasures. The executive order seeks to ensure sufficient and reliable long-term domestic production of these products, and to minimize potential shortages by reducing U.S. dependence on foreign manufacturers. The ultimate goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as against any other potential public health emergencies.

FDA Approves New Claims for Roche Lung Cancer Co-Diagnostic

Roche has received Food and Drug Administration (FDA) approval of expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic for a broad group of therapies used in the treatment of non-small cell lung cancer (NSCLC). The cobas EGFR Mutation Test v2 uses real-time polymerase chain reaction to qualitatively detect defined mutations of the epidermal growth factor receptor (EGFR) gene in NSCLC patients. It analyzes DNA isolated from formalin-fixed paraffin-embedded tumor tissue or circulating tumor DNA from plasma derived from EDTA anti-coagulated peripheral whole blood. This claim expansion allows clinical laboratories to use the test as a companion diagnostic for all five FDA-approved EGFR tyrosine kinase inhibitor (TKI) therapies targeting the EGFR mutation L858R and exon 19 deletions. The group claim will also enable labs to use the test as a companion diagnostic for any EGFR TKI therapies targeting the same mutations that might be approved in the future, without the need to conduct individual clinical studies with the test for each new therapy.

FoundationOne Liquid CDx Earns FDA Approval for 4 New Co-Diagnostic Indications

The Food and Drug Administration (FDA) has approved Foundation Medicine’s FoundationOne Liquid CDx test to help identify patients who might benefit from treatment with four FDA-approved targeted therapies. These new companion diagnostic indications are for Piqray (alpelisib), Rubraca (rucaparib), Alecensa (alectinib), and Lynparza (olaparib). Piqray is a kinase inhibitor from Novartis indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated advanced or metastatic breast cancer. Rubraca is Clovis Oncology’s poly (ADP-ribose) polymerase inhibitor for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alecensa is a tyrosine kinase inhibitor from Genentech indicated for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer. While Lynparza, which was developed by AstraZeneca and Merck, is approved for metastatic castration-resistant prostate cancer patients who carry mutations in homologous recombination repair genes.

Fujirebio Submits Test for Alzheimer’s Amyloid Plaques to FDA for Clearance

Fujirebio Diagnostics has filed for 510(k) premarket clearance with the Food and Drug Administration (FDA) for its Lumipulse G ß-Amyloid Ratio (1-42/1-40) test. FDA granted the test breakthrough device designation in February 2019, and Fujirebio expects it to be among the first commercially available in vitro diagnostic tests in the U.S. that aids in the assessment of Alzheimer’s disease. The test is designed for use in adult patients age 50 years or older who present with signs of cognitive impairment. It runs on Fujirebio’s fully automated Lumipulse G1200 instrument system and measures cerebral spinal fluid concentrations of ß-amyloid 1-42 and ß-amyloid 1-40, which are both major components of the amyloid plaques found in the brains of patients with Alzheimer’s. The test then combines these measurements into a ratio of ß-amyloid 1-42 / ß-amyloid 1-40, which can be used to estimate the presence of amyloid pathology and to evaluate patients for Alzheimer’s disease and other causes of cognitive decline.

CE Mark Granted to Ortho for Transfusion Lab Testing Platform

Ortho Clinical Diagnostics has received the CE mark for the semiautomated Ortho Optix reader, an immunohematology platform designed for low- to mid-volume transfusion labs that can’t afford to invest in the typical automated platform. When paired with the Ortho workstation, the Optix reader provides a complete semiautomated testing platform. Its high-resolution camera captures color, grayscale, and front and back images of each test without operator intervention, which provides objective data for automated results interpretation and eliminates the subjectivity and discrepancies of multiple operators reviewing images manually. Additionally, the Ortho Optix reader uses the same Ortho BioVue system column agglutination technology as the Ortho Vision analyzer, and features a comprehensive testing menu including antibody panels, selected cells, and dilution series.