As we take our first steps into 2023, now seems like a good time to look back and reflect on 2022. Set against a backdrop of the continuing global COVID-19 pandemic, ongoing research breakthroughs across several science and medical fields, and intensifying interest in living healthier lifestyles, 2022 proved to be an eventful year for scientific research and industry.
OraSure Technologies — with its subsidiary companies DNA Genotek, Novosanis, and Diversigen — is pleased to commemorate this past year by going over our cross-company list of the top 5 research and industry advances of 2022. Without further ado and in no particular order:
As a result of the COVID-19 global pandemic, we witnessed a global-scale vaccination effort to prevent the worst of the disease. More than 3 years have passed since the start of the pandemic and, fortunately, several scientists believe the worst is behind us. Though there are hopeful signs that the pandemic is shifting to an endemic disease stage,1 we continue to experience waves of infection and increased hospitalization with each new coronavirus 2 (SARS-CoV-2) variant.
New variants of SARS-CoV-2 have prolonged the COVID-19 pandemic and continue to impact us globally. For instance, 2022 was the year of the Omicron variant. First detected in late 2021, Omicron quickly went on to become the dominant variant around the world due to its increased transmissibility, though with quantifiably less severe illness compared to the former leading variant, Delta.2 Continued evolution of SARS-CoV-2 has proved problematic toward the development of a single vaccine capable of protecting against all variants.
Multiple research laboratories globally are working to find a solution to combat the multiple SARS-CoV-2 variants. One study by Ng et al. (2022), published in Science Translational Medicine, sought to develop a pan-coronavirus vaccine — a vaccine that could potentially work against most, if not all, past, present, and future variants. In their study, the researchers identified a conserved vaccine target — a specific region of the spike protein, called S2, of the SARS-CoV-2 virus — that is shown to undergo fewer mutations than previously targeted regions. Importantly, in vaccinated test mice, this vaccine resulted in the production of antibodies capable of neutralizing several animal and human coronaviruses.3
Near the end of 2022, companies Pfizer and Moderna also released their bivalent COVID-19 booster shots designed to target two strains of the same virus or two different viruses.4 Unlike the original mRNA-based COVID-19 vaccines developed separately by both Pfizer and Moderna, bivalent boosters contain two mRNA components that can recognize two variants of the SARS-CoV-2 virus.
In 2021, our parent company, OraSure Technologies, released its latest product for the detection of infectious diseases, the InteliSwab®COVID-19 Rapid Test. Designed to detect active COVID-19 infection (including multiple variants), the InteliSwab® test is currently under Emergency Use Authorization (EUA) by the United States (U.S.) and is approved for over-the-counter use. In 2022, the U.S. Food and Drug Administration (FDA) authorized — under an EUA — the use of the InteliSwab® test for children aged 2-14,5 and in the same year, the test was also validated for the detection of several Omicron subvariants (i.e., BA.2, BA.2.12.1, BA.3, and BA.5).6
In terms of human immunodeficiency virus (HIV) developments, a new self-testing program, Together TakeMeHome™, was rolled out in September of 2022.7 This program — developed in partnership with Building Healthy Online Communities (BHOC), Emory University, and NASTAD — aims to reach marginalized communities such as men who have sex with men (MSM) and trans/non-binary individuals who use dating apps. With its confidential and discreet home-based testing options, including oral swab and lab-based testing, the program is helping to increase accessibility and reduce barriers to testing. By promoting self-testing, the program aims to increase testing rates and reduce stigma in the HIV community. Under the program, the Centers for Disease Control and Prevention (CDC) will provide $41.5 million over a five-year period to support community testing.8 OraSure Technologies is proud to be the supplier of OraQuick™ In-Home HIV test kits for this program, which is managed by Emory University.
Just like blood, saliva contains white blood cells — a source of nucleic acids (DNA and RNA) that can provide a wealth of information about an individual’s health. In addition, saliva can also supply microbial and viral DNA and RNA. Due to the ease of acquiring saliva from individuals, saliva has long been seen as a desirable sample type for both diagnostic and research purposes. In 2022, several biotechnology companies developed non-invasive diagnostic tests that utilized saliva as a source of nucleic acids.
Quadrant Biosciences and two of its academic partners, the State University of New York Research Foundation and the Penn State Research Foundation, were awarded a U.S. patent for their methods in diagnosing mild traumatic brain injury (mTBI) by detecting specific microRNA (miRNA) associated with traumatic brain injury. Their technology relies on RNA isolated from human saliva samples to diagnose patients who have suffered trauma to their head and are at risk for concussion. In multiple studies, the researchers used ORAcollect™•RNA collection kits to collect saliva.9,10 Together with their extensive research efforts, this patent serves as the foundation for the development and launch of Clarifi™ mTBI Saliva Test, a novel diagnostic test for concussions, expected to be available late 2023.11
On a related note, the ORAcollect™•Dx saliva collection device, created by DNA Genotek, a subsidiary company of OraSure Technologies, received over-the-counter (i.e., direct-to-consumer) use, and general clearance from the FDA in late 2022. This designation was acquired in partnership with Grifols, a leading global healthcare company, and allows for ORAcollect™•Dx devices to be used and legally marketed by OraSure’s commercial partners.12
Aside from evaluating human health, biological sample types such as saliva and stool can also be valuable for evaluating animal health. Although there were a multitude of note-worthy animal-related accomplishments in 2022, here we focus on two important milestones in animal health and pet care.
In 2022, research by the Darwin’s Ark project, led by Dr. Elinor Karlsson (founder and chief scientist of Darwin’s Ark), was published in the peer-reviewed journal, Science. In this study, the researchers looked at dog breed ancestry and enlisted the help of pet owners to fill out surveys and collect saliva samples, collected using PERFORMAgene kits, from enrolled dogs to conduct DNA sequencing. Thanks to the simplified collection and stabilization of DNA from saliva collection kits, the researchers were able to enroll dogs from all over the world.13
Also in 2022, Mars Petcare announced the development of their companion animal MARS Petcare Biobank™ to advance our understanding of pet health through their gut microbiomes. The MARS Petcare Biobank™ project, a collection of companion animal biological samples and information to enable scientific investigations, aims to enroll both pet dogs and cats. As part of the project, Mars Petcare is partnering with Diversigen, a subsidiary company of OraSure Technologies, to conduct metagenomic sequencing on collected samples for the development and analysis of pet microbiome profiles.14
The ongoing study of the human gut microbiome is a highly active field of research and shows great potential and promise for future healthcare initiatives. Briefly, scientists have found several connections between the gut microbiota of an individual and their overall health, including several correlations between diseases and the identity and abundance of specific gut bacteria.
The past year was a memorable one for gut microbiome research and industry. First, to highlight the discovery potential within the research field, 2022 was the year in which Prolacta Bioscience published a proof-of-concept study in the peer-reviewed journal, Cell Host & Microbe, where they demonstrated the reversible engraftment of a milk-based synbiotic (a mixture of probiotics and prebiotics) in the human adult gut microbiome. In their study, the scientists used Bifidobacterium infantis (probiotic) and human milk oligosaccharides (prebiotic) to introduce a sustained change in the adult gut microbiome (reliant on the presence of human milk oligosaccharides) that could be reversed without the use of antibiotics.15
Second, for the first time, the FDA approved or authorized two notable microbiome products in 2022. Both FDA developments mark the growing interest and discovery potential in studying the human gut microbiome.
The fecal microbiota product, REBYOTA™ was approved for use in preventing the recurrence of Clostridioides difficile infection (CDI) in people 18 years or older who have already completed antibiotic treatment for recurrent CDI.16
The first and only stool sample collection device, OMNIgene™•GUT Dx by DNA Genotek, was authorized for the collection and stabilization of human microbial DNA to be used for microbiome profiling studies.17
Urine, as a biological sample type, provides a valuable snapshot into an individual’s health. As we now know, urine contains analytes such as proteins, extracellular vesicles (including extracellular vesicle RNA), and other useful cellular debris (e.g., cell-free DNA) that can all serve as tools for human disease screening.
In 2022, several peer-reviewed research publications explored the screening and diagnostic potential of urine for diseases such as prostate cancer, cervical cancer, chronic kidney disease, Alzheimer’s disease, and COVID-19.18,19,20 The use of urine as a sample type to screen for cervical cancer is already well-established in terms of supporting literature.
Cervical cancer is the fourth most common cancer affecting women worldwide.21 Most cervical cancer cases are preventable as they arise due to infection by high-risk human papillomavirus (HPV) primarily transmitted through sexual contact. The standard approach for detecting HPV infection is a procedure known as the Papanicolaou (Pap) smear test, where cells from the cervix are collected to check for abnormalities.
In 2022, several studies used human urine — in particular, first-void urine (i.e., typically the first 20-30 mL of urine flow) — to detect HPV.22,23 This could significantly improve screening coverage and access those who do not routinely attend cervical cancer screening programs. One 2022 study published in the journal eClinicalMedicine, used the Colli-Pee™ urine collection device and was the first to study HPV screening in transpeople — an understudied patient population.22 As a sample type, urine has thus far shown reliable results in HPV-based cervical cancer screening, and a majority of the study participants in several studies prefer to provide a non-invasive first-void urine sample over undergoing a Pap smear test.22,24
On a similar note, in 2022, Novosanis received a new CE mark — a symbol designating conformation with the European Union’s standards on health, safety, and environmental protection — for its Colli-Pee™ UAS FV-5040 first-void urine collection device. This device includes a prefilled tube with the Novosanis UAS™ preservative, designed to preserve urinary analytes (i.e., cell-free DNA, extracellular vesicle RNA). As of now, all variants of the Colli-Pee™ urine collection device (Neat, UCM®, and UAS™) are FDA listed, and can be found on our dedicated U.S. webpage.
OraSure Technologies — with its subsidiary companies: DNA Genotek, Novosanis, and Diversigen — aims to improve health and wellness by empowering the global community through its diverse offerings. As a leader in the development, manufacturing, and distribution of rapid diagnostic tests, sample collection and stabilization kits, and customizable molecular services, the company aims to support research and diagnostic discoveries by facilitating access to accurate and essential biological data.
As an example, subsidiary company DNA Genotek offers saliva collection products that can be used to isolate DNA and/or RNA, offering non-invasive sampling to support your clinical and/or basic research needs. If you are interested in expanding your DNA or RNA sample collection abilities, learn more about our Oragene™•DNA, ORAcollect™•DNA, and ORAcollect™•RNA products on our website or send us an email at info@dnagenotek.com. Click on the graphic below to test out our kits for yourself.
References
1. Biancolella M, Colona VL, Mehrian-Shai R, Watt JL, Luzzatto L, Novelli G, Reichardt JKV. (2022) COVID-19 2022 update: transition of the pandemic to the endemic phase. Hum Genomics. doi: 10.1186/s40246-022-00392-1
2. Nyberg T, Ferguson NM, Nash SG, Webster HH, Flaxman S, Andrews N, Hinsley W, Bernal JL, Kall M, Bhatt S, Blomquist P, Zaidi A, Volz E, Aziz NA, Harman K, Funk S, Abbott S; COVID-19 Genomics UK (COG-UK) consortium; Hope R, Charlett A, Chand M, Ghani AC, Seaman SR, Dabrera G, De Angelis D, Presanis AM, Thelwall S. (2022) Comparative analysis of the risks of hospitalisation and death associated with SARS-CoV-2 omicron (B.1.1.529) and delta (B.1.617.2) variants in England: a cohort study. Lancet. doi: 10.1016/S0140-6736(22)00462-7
3. Ng KW, Faulkner N, Finsterbusch K, Wu M, Harvey R, Hussain S, Greco M, Liu Y, Kjaer S, Swanton C, Gandhi S, Beale R, Gamblin SJ, Cherepanov P, McCauley J, Daniels R, Howell M, Arase H, Wack A, Bauer DLV, Kassiotis G. (2022) SARS-CoV-2 S2-targeted vaccination elicits broadly neutralizing antibodies. Sci Transl Med. doi: 10.1126/scitranslmed.abn3715
4. FDA News Release. (2022) Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose. [News Article]
5. OraSure Technologies, Inc. (2022) InteliSwab® COVID-19 Rapid Tests Receive U.S. FDA Authorization for Pediatric Use and Company Launches New InteliSwab® Connect Reporting App. [Press Release Document]
6. OraSure Technologies, Inc. (2022) InteliSwab® COVID-19 Rapid Test Validated to Detect the Omicron BA.2, BA.2.12.1, BA.3 and BA.5 Subvariants. [Press Release Document]
7. BHOC - Self-testing. TakeMeHome™ – A New Free HIV/STI Self-Testing Program. [Webpage]
8. Emory University. (2022) Emory receives CDC award to deliver 1 million rapid HIV self-tests across the country. Emory News Center. [News Article]
9. Hicks SD, Olympia RP, Onks C, Kim RY, Zhen KJ, Fedorchak G, DeVita S, Rangnekar A, Heller M, Zwibel H, Monteith C, Gagnon Z, McLoughlin CD, Randall J, Madeira M, Campbell TR, Fengler E, Dretsch MN, Neville C, Middleton FA. (2020) Saliva microRNA biomarkers of cumulative concussion. Int J Mol Sci. doi: 10.3390/ijms21207758
10. Hicks SD, Onks C, Kim RY, Zhen KJ, Loeffert J, Loeffert AC, Olympia RP, Fedorchak G, DeVita S, Gagnon Z, McLoughlin C, Madeira MM, Zuckerman SL, Lee T, Heller M, Monteith C, Campbell TR, Neville C, Fengler E, Dretsch MN. (2021) Refinement of saliva microRNA biomarkers for sports-related concussion. J Sport Health Sci. doi: 10.1016/j.jshs.2021.08.003
11. Leggard A. (2022) CNY company uses saliva test to help diagnose concussion in only 6 to 8 hours. CNY Central. [News Article]
12. OraSure Technologies, Inc. (2022) OraSure Technologies Receives General Clearance for its ORACollect®•Dx Device for Over-the-Counter (OTC) Use from the U.S. Food and Drug Administration (FDA). [Press Release Document]
13. Morrill K, Hekman J, Li X, McClure J, Logan B, Goodman L, Gao M, Dong Y, Alonso M, Carmichael E, Snyder-Mackler N, Alonso J, Noh HJ, Johnson J, Koltookian M, Lieu C, Megquier K, Swofford R, Turner-Maier J, White ME, Weng Z, Colubri A, Genereux DP, Lord KA, Karlsson EK. (2022) Ancestry-inclusive dog genomics challenges popular breed stereotypes. Science. doi: 10.1126/science.abk0639
14. OraSure Technologies, Inc. (2022) OraSure Partners with Mars Petcare in One of the Largest Ever Microbiome Studies to Evaluate Pet Health. [Press Release Document]
15. Button JE, Autran CA, Reens AL, Cosetta CM, Smriga S, Ericson M, Pierce JV, Cook DN, Lee ML, Sun AK, Alousi AM, Koh AY, Rechtman DJ, Jenq RR, McKenzie GJ. (2022) Dosing a synbiotic of human milk oligosaccharides and B. infantis leads to reversible engraftment in healthy adult microbiomes without antibiotics. Cell Host Microbe. doi: 10.1016/j.chom.2022.04.001
16. FDA News Release. (2022) FDA Approves First Fecal Microbiota Product. [News Article]
17. OraSure Technologies, Inc. (2022) OraSure Technologies’ Subsidiary DNA Genotek Launches the First Device with De Novo Authorization from the FDA for the Preservation and Stabilization of Microbiome Samples. [Press Release Document]
18. Takizawa K, Ueda K, Sekiguchi M, Nakano E, Nishimura T, Kajiho Y, Kanda S, Miura K, Hattori M, Hashimoto J, Hamasaki Y, Hisano M, Omori T, Okamoto T, Kitayama H, Fujita N, Kuramochi H, Ichiki T, Oka A, Harita Y. (2022) Urinary extracellular vesicles signature for diagnosis of kidney disease. iScience. doi: 10.1016/j.isci.2022.105416
19. Wang Y, Wang Y, Zhu J, Guan Y, Xie F, Cai X, Deng J, Wei Y, He R, Fang Z, Guo Q. (2022) Systematic evaluation of urinary formic acid as a new potential biomarker for Alzheimer's disease. Front Aging Neurosci. doi: 10.3389/fnagi.2022.1046066
20. Ludolf F, Ramos FF, Bagno FF, Oliveira-da-Silva JA, Reis TAR, Christodoulides M, Vassallo PF, Ravetti CG, Nobre V, da Fonseca FG, Coelho EAF. (2022) Detecting anti-SARS-CoV-2 antibodies in urine samples: A noninvasive and sensitive way to assay COVID-19 immune conversion. Sci Adv. doi: 10.1126/sciadv.abn7424
21. Arbyn M, Weiderpass E, Bruni L, de Sanjosé S, Saraiya M, Ferlay J, Bray F. (2020) Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. doi: 10.1016/S2214-109X(19)30482-6
22. Pils S, Mlakar J, Poljak M, Domjanič GG, Kaufmann U, Springer S, Salat A, Langthaler E, Joura EA. (2022) HPV screening in the urine of transpeople - a prevalence study. EClinicalMedicine. doi: 10.1016/j.eclinm.2022.101702
23. Van Keer S, Latsuzbaia A, Vanden Broeck D, De Sutter P, Donders G, Doyen J, Tjalma WAA, Weyers S, Arbyn M, Vorsters A. (2022) Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. J Clin Virol. doi: 10.1016/j.jcv.2022.105271
24. Schaafsma M, van den Helder R, Bleeker MCG, Rosier-van Dunné F, van der Avoort IAM, Steenbergen RDM, van Trommel NE. (2022) Experiences and preferences towards collecting a urine and cervicovaginal self-sample among women attending a colposcopy clinic. Prev Med Rep. doi: 10.1016/j.pmedr.2022.101749