NEW YORK – In the three years since the start of the COVID-19 pandemic, SARS-CoV-2 testing has garnered the lion's share of attention from the diagnostic industry.
But as the demand for and revenues from COVID-19 testing have waned, and as the US Food and Drug Administration has shifted its focus to reviewing only a small subset of Emergency Use Authorization requests for COVID-19 tests, the industry has returned some of its attention to other infectious diseases.
Many newer companies that started with COVID-19 tests have spent 2022 expanding into combination tests for both SARS-CoV-2 and influenza, despite questions about whether they'll be adopted. For example, Lucira Health, which originally received EUA from the US Food and Drug Administration for its molecular point-of-care COVID-19 test in 2020, garnered EUA for a combo COVID-19/influenza test in November. Meanwhile, Cue Health, which went public in 2021 on the back of its point-of-care molecular diagnostic reader and COVID-19 test, has worked to broaden its menu, submitting an influenza test to the FDA for regulatory approval in September. A combination test for SARS-CoV-2 and influenza has also been submitted to the agency for EUA.
In addition, Visby Medical, another firm that originally received EUA for a handheld PCR-based COVID-19 test, nabbed EUA for a combination SARS-CoV-2 and influenza A/B test last month, and LumiraDx, which went public in 2021 largely thanks to growth from its COVID-19 testing business, received CE marking for its COVID-19/influenza test in June.
Newer firms weren't the only ones that focused on multianalyte respiratory virus tests. Laboratory Corporation of America received EUA in May for a direct-to-consumer RT-PCR test to detect influenza, SARS-CoV-2, and respiratory syncytial virus. Meantime, Becton Dickinson garnered CE-IVD marking for its BD Max respiratory panel test in June and said it would submit the test for EUA, and Siemens Healthineers got CE marking for two combination respiratory virus tests in September. Other firms, such as DiaCarta, Hologic, Thermo Fisher Scientific, DiaSorin subsidiary Luminex, and QuantuMDx, garnered regulatory approval for respiratory virus tests, as well.
Monkeypox in the mix
Midway through the year, many public health experts added monkeypox to their list of concerns after a worldwide outbreak, and diagnostic test developers followed their lead. Starting in May, thousands of cases of monkeypox were reported across the globe, spurring test development from commercial and academic laboratories. When the outbreak began, the FDA-cleared non-smallpox orthopox virus test from the US Centers for Disease Control and Prevention was one of the only tests available in the US to detect the disease, with tests being shipped to five commercial laboratories that would perform the testing.
But by September, when the US Department of Health and Human Services authorized the FDA to issue EUAs for monkeypox tests, multiple tests had been developed: Quest Diagnostics, which received the first monkeypox test EUA, began offering its internally developed test in July, and firms like CorDx and Anitoa Systems had developed their own tests and received CE marking.
After Quest's initial EUA, other large diagnostic companies have followed suit and received authorization for molecular monkeypox tests, including Abbott, Roche, Thermo Fisher, and Becton Dickinson. Danaher subsidiary Cepheid is also developing a monkeypox test for its GeneXpert system in collaboration with BioGX, it announced in June.
The FDA also recently released further guidance for monkeypox test developers related to antigen testing and has encouraged developers to work on over-the-counter molecular tests for the disease, as well.
STIs, tuberculosis receive renewed attention
During the depths of the pandemic, there was little focus on non-COVID-19 infectious diseases, particularly sexually transmitted infections and tuberculosis — two disease areas that public health advocates previously had raised the alarm on. STI testing, in particular, dropped off the radar during the first year of the pandemic, though, it turns out, rates of infections rose during the period. Many laboratories and companies have since shown a renewed emphasis on developing and commercializing STI tests — with a trend toward multiplex assays — in 2022.
Firms that gained prominence for COVID-19 testing, such as Cue and Lucira, also have STI tests in development. Cue stated in its most recent earnings call that it planned to begin clinical studies for a combination chlamydia and gonorrhea test in Q4 2022, and Lucira announced preliminary data from a pilot study to assess the performance of its at-home chlamydia and gonorrhea test in October.
Abbott, meantime, received clearance from the FDA in May for its molecular assay that differentiates between Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. In the same month, Becton Dickinson nabbed FDA clearance for its molecular triplex STI test detecting chlamydia, gonorrhea, and trichomonas.
The federal government has also encouraged STI test development as the CDC inked a $3.2 million contract with Chembio Diagnostics to develop a point-of-care syphilis test. And as part of an initiative to expand access to HIV testing, the centers signed a five-year contract with OraSure Technologies to provide up to 1 million of its OraQuick In-Home HIV Tests to distribute to the public.
Along with STIs, tuberculosis caught renewed attention from test developers and global organizations last year, although the disease has long been a focus of the World Health Organization and other nonprofits. On the nonprofit side, the Seq&Treat project from nonprofit FIND has been evaluating next-generation sequencing diagnostic solutions for drug-resistant tuberculosis and rolling out clinical studies in multiple countries with participation from companies like Advanced Biological Laboratories, GenoScreen, and Oxford Nanopore Technologies.
Later in the year, Unitaid announced $30 million in funding for partnerships with FIND and the Liverpool School of Tropical Medicine to accelerate the introduction of new diagnostic technologies, evaluate alternative sample collection methods, and develop and test combination approaches to tuberculosis diagnosis.
The World Health Organization also announced in September that it would expand its invitation for tuberculosis molecular diagnostic prequalification assessment to include manufacturers of qualitative assays.
Researchers from Tulane University are also developing a CRISPR-based blood test for tuberculosis that would bypass the need for sputum-based diagnostics.
Bridging the nonprofit and for-profit spheres, last month, LumiraDx announced that it had received $14.2 million in grant funding from the Bill & Melinda Gates Foundation to develop a point-of-care molecular assay for tuberculosis. It would be the first molecular test to run on LumiraDx's microfluidics-based portable testing platform, the firm noted.
Other for-profit companies are working on developing and commercializing their own tuberculosis assays, such as UK-based PBD Biotech, which has a blood-based test to predict which individuals with latent tuberculosis might progress to active disease. The firm received £2.4 million ($2.9 million) in funding to support clinical trials for the test, it announced in October.
Illumina and GenoScreen, meantime, have partnered to combine Illumina's NGS reagents with GenoScreen's sequencing test for tuberculosis and other bacteria, as well as the prediction of antibiotic resistance. GenoScreen's test is included in FIND's Seq&Treat program.