On May 21, the Food and Drug Administration (FDA) created a public list of SARS-CoV-2 serology tests that the agency has removed from its so-called notification list for SARS-CoV-2 tests. This means that these tests can no longer be marketed under the terms of the agency’s current policy for authorizing tests intended to aid in managing the COVID-19 public health emergency.
At the start of the COVID-19 outbreak, FDA responded to concerns that its regulations were hampering testing by allowing in vitro diagnostic companies to develop and market SARS-CoV-2 serology tests without applying for emergency use authorization (EUA). However, this led to a flood of serology tests hitting the market that were of dubious quality. FDA therefore revised its guidance for SARS-CoV-2 serology tests in early May so that manufacturers must now submit an EUA within 10 business days after the date they notify FDA of their test validation or the date that FDA published the revised policy, whichever is later.
The new removal list includes tests that manufacturers have voluntarily withdrawn in the wake of FDA’s revised serology test guidance, as well as those tests for which manufacturers did not submit EUA requests within the 10-day window. In a public statement, FDA said that it expects manufacturers to stop distributing tests on the removal list, and that it will continue updating the list as needed.
Foundation Medicine, Myriad Get Multiple Co-Diagnostic Approvals From FDA
The Food and Drug Administration (FDA) has approved Foundation Medicine’s next-generation sequencing-based FoundationOne CDx test to aid in identifying patients with non-small cell lung cancer (NSCLC) for whom treatment with Tabrecta (capmatinib) might be appropriate. Tabrecta, which was developed by Novartis, is currently the only FDA-approved therapy for patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping, which occurs in 3% to 4% of NSCLC cases.
FDA has also approved both FoundationOne CDx and Myriad Genetics’ BRACAnalysis CDx for use as companion diagnostics for Lynparza (olaparib), which received simultaneous approval for use in patients who have deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer and who have progressed following prior treatment with enzalutamide or abiraterone. This is the seventh regulatory approval Myriad has received for BRACAnalysis CDx in support of Lynparza, a novel poly ADP ribose polymerase (PARP) inhibitor jointly developed by AstraZeneca and Merck.
Additionally, Myriad’s myChoice CDx has received FDA approval to aid in identifying advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status who are eligible or might become eligible for first-line maintenance treatment with Lynparza in combination with bevacizumab. MyChoice CDx is a comprehensive HRD test that identifies people with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to PARP inhibitors.
FDA Clears Cancer Genomic Profiling Test From Personal Genome Diagnostics
Personal Genome Diagnostics, a company established by researchers from Johns Hopkins University specializing in cancer genome sequencing and liquid biopsy technologies, has earned Food and Drug Administration clearance for PGDx elio tissue complete. This diagnostic kit is designed to enable molecular laboratories to perform genomic profiling of cancer in a more efficient manner. PGDx elio tissue complete detects single nucleotide variants and small insertions and deletions in more than 500 genes, select amplifications and translocations, and genomic signatures including microsatellite instability and tumor mutation burden. The assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and to help oncologists identify patients for clinical trial participation. It also includes software that automates the data analysis process. Personal Genome Diagnostics supported the 510(k) submission for this test with accuracy data across all genetic variant classes in clinical samples from 35 tumor types.
Binx POC Test for Chlamydia, Gonorrhea Gets FDA OK for Use on Male Urine Specimens
The Food and Drug Administration (FDA) has given a second 510(k) clearance to binx health’s molecular point-of-care (POC) platform, the binx io, which will enable healthcare professionals to use this test to detect chlamydia and gonorrhea in male urine specimens. Previously in 2019, FDA also cleared the binx io for use with clinician and self-collected vaginal swab specimens. The binx io platform couples polymerase chain reaction amplification with proprietary electrochemical detection technology to produce chlamydia and gonorrhea test results in about 30 minutes. To evaluate the platform’s performance, binx performed a multi-center clinical trial involving 10 evaluation sites across the U.S. and samples collected from 922 male symptomatic and asymptomatic patients. Non-laboratorians in POC settings processed 94% of all patient samples. The study compared results for male urine specimens run on the binx io with results from three FDA-cleared laboratory tests, and found that the binx io showed a 92.5% sensitivity and 99.3% specificity for chlamydia and 97.3% sensitivity and 100% specificity for gonorrhea.
CE Mark Granted to Advanced Biological Laboratories for HIV Drug Resistance Tests
Advanced Biological Laboratories (ABL) has received the CE mark for its two DeepChek-HIV drug resistance assays, which use capillary electrophoresis and next-generation sequencing (NGS) to genotype HIV-1 group M viruses. The first assay covers the protease and reverse transcriptase regions of the virus while the second assay covers the integrase region. Both tests are performed using RNA extracted from plasma, serum, or whole blood samples, and they have been validated to process clinical samples with viral loads as low as 1,000 copies/mL. According to ABL, the DeepChek-HIV assays exhibit 100% agreement on analytical reproducibility and repeatability, 100% clinical reproducibility, and 99% clinical sensitivity for all three HIV genomic regions. The tests can also be used in a broad range of laboratory settings running either Sanger or NGS workflows, and they have been validated together with the DeepChek Library Preparation assays on several NGS platforms from Illumina, including the iSeq100 instrument.