The Food and Drug Administration (FDA) has established additional conditions of authorization for certain SARS-CoV-2 tests that have received emergency use authorization (EUA).

Developers of molecular, antigen, and serology SARS-CoV-2 tests must update authorized labeling and evaluate how variants affect test performance, FDA said in a September 23 letter. Developers must update labeling within 3 months, submit the updates as a supplement to the EUA, and evaluate viral mutations’ impact on test performance.

Developers also must conduct ongoing evaluation of mutations on target analytes and include any additional data analysis requested by FDA in response to performance concerns. If viral mutations affect the expected test performance, developers must notify the agency immediately. In response to specific FDA requests, developers must update labels within 7 days to include additional agency-identified risk mitigations about the impact of viral mutations on test performance.

The revisions aren’t required for IL-6 tests, standalone specimen collection devices, or standalone home collection kits.

SARS-CoV-2 Test Kits Recalled

Abbott Molecular has recalled its Alinity m SARS-CoV-2 AMP kit and Alinity m Resp-4-Plex AMP kit for their potential to give false-positive results.

Using the kits may cause serious adverse health consequences or death, the Food and Drug Administration (FDA) said in an October 15 recall classification notice.

Software associated with the kits causes the potential for false-positive results, the FDA notice says. The recall is intended to correct the software. Positive results from kits used before the software correction should be treated as presumptive, while labs may resume using the kits after software correction, FDA said.

The FDA notice follows a September Abbott Molecular recall to all impacted customers. That recall requested that customers complete and return an acknowledgement letter that the notice was received and consider all positive SARS-CoV-2 test results presumptive until the company can implement the software correction for each customer’s laboratory site.

A September 17 FDA letter to clinical laboratory staff suggested using an alternate authorized SARS-CoV-2 test to retest patient specimens found positive via the two recalled tests performed in the prior 2 weeks. The letter also suggested telling affected patients that they may have had a positive test result.

Patients are encouraged to contact Abbott Technical Support for more information on the recall.

FDA Recognizes Memorial Sloan-Kettering Tumor Marker Information

The Food and Drug Administration (FDA) in October granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB), making it the first tumor mutation database to be included in the Public Human Genetic Variant Databases.

The OncoKB database contains detailed information on specific variations in 682 cancer genes. FDA recognized a portion of the OncoKB as a source of valid scientific evidence for biomarkers of clinical significance and potential clinical significance. Test developers can use data from this part of OncoKB to support the clinical validity of tumor profiling tests in premarket submissions.

FDA recognition followed a review of operating and governance procedures and policies, processes for the database and for variant evaluation and curation, and method of assignment of clinical significance. OncoKB data are sorted into one of two levels of clinical significance consistent with FDA-authorized tumor profiling tests and displayed on a tab referred to as “FDA recognized alterations.”

Determining the mutation profile of a tumor using DNA sequencing enables the use of targeted therapies and investigational treatment options.

OpGen Receives FDA Clearance for Acuitas AMR Gene Panel

OpGen has received Food and Drug Administration (FDA) 510(k) clearance to market its Acuitas AMR Gene panel.

The Acuitas AMR Gene panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens. The panel helps clinicians manage patients with known or suspected antibiotic nonsusceptible or resistant bacterial infections, according to the company. 

The panel provides genomic profile data in about 2.5 hours, versus conventional tests that deliver phenotypic information in 1–4 days, according to the company. The test will help prevent indiscriminate overuse and misuse of antibiotics, support infection control and prevention measures, and alert providers to genes conferring resistance to nine classes of antibiotics. They include aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, polymyxins, sulfonamides, trimethoprim, and vancomycin.

New Genedrive System Receives CE-IVD Mark

The Genedrive System platform has received CE-IVD marking in anticipation of launch in the United Kingdom and European Union, according to a recent Genedrive announcement.

The company developed the platform to support the commercial launch of the Genedrive MTRNR1 ID kit, which screens for m.1555A>G mutations. Babies with these mutations can suffer lifelong deafness after receiving the commonly used antibiotic gentamicin. The test identifies these babies and alerts providers to the need for alternative treatments.

Antibiotics should be delivered within an hour of any decision to treat, and current lab-based genetic technologies are not sufficiently rapid to detect the MT-RNR1 mutation within a clinically relevant timeframe, according to the company. It adds that the kit supports the first use of point-of-care molecular diagnostics in a neonatal urgent care setting.

New York State Approves Multi-Cancer Early Detection Blood Test

The New York State Department of Health has approved Galleri, GRAIL’s multicancer early detection blood test, which identifies more than 50 types of cancer. The test works by first detecting a cancer signal, then predicting where the cancer is located in the body to help guide the next steps to diagnosis.

The Galleri test is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. It requires a prescription and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. GRAIL also cautions that a negative Galleri result does not rule out cancer.