Testing is one of the biggest challenges facing healthcare providers amidst the coronavirus outbreak. In response to the rapidly growing need and the shortage of laboratory-based molecular testing capacity and reagents, several diagnostic test manufacturers around the world are committed to developing and supplying rapid coronavirus testing kits to detect the virus. While there are currently a large number of coronavirus (COVID-19) testing kit manufacturers involved in the development of diagnostic kits, for the market deployment, the manufacturers will have to obtain clinical specimens from the CDC and local health authorities. These are needed to validate their tests in order to obtain FDA authorization.
SpendEdge has been actively monitoring the coronavirus (COVID-19) impact on procurement and supply of diagnostic testing kits in global markets. Our experts have identified the top 100 coronavirus testing kit manufacturers in the world that have received authorization from concerned health authorities.
Coronavirus (COVID-19) Diagnostic Test Kits Manufacturers
Abbott is a world leader in rapid diagnostics at the point of care. The company primarily focuses on cardio metabolic disease, infectious disease, and toxicology. Being prominent in the field of diagnostic testing, the company is now one of the top Coronavirus (COVID-19) testing kit manufacturers in the US.
Another notable player among the coronavirus (COVID-19) test kit manufacturers in the US, Avellino is headquartered in Silicon Valley, California. The company specializes in precision medicine and aims to create new opportunities for earlier disease protection through genetic disorder testing, beginning with ophthalmology.
BD is a global medical technology company that provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, and equip surgical and interventional procedures. Currently, the company is working relentlessly to reduce the coronavirus (COVID-19) impact on procurement of their medical devices. Their manufacturing and distribution centers that provide medical devices essential to diagnosing or treating patients with coronavirus are operational. The company is one of the coronaviruses (COVID-19) test kit manufacturers with 95 percent of their critical-to-COVID locations operating at or close to full capacity.
BGI Genomics is a well-known provider of genomic sequencing services and proteomic services across 66+ global locations. From the beginning of the coronavirus outbreak, the company has been actively involved in assisting researchers and coronavirus (COVID-19) test kit manufacturers to understand further the molecular structure of SARS-CoV-2 and pathogenesis of the disease COVID-19.
BioFire Diagnostics, Inc. is a privately held clinical diagnostics company based in Salt Lake City, Utah. The company manufactures and distributes the user-friendly FilmArray system to hospital-based clinical laboratories across the U.S. and EU. BioFire currently offers the FilmArray Respiratory (RP) Panel and the Blood Culture Identification (BCID) Panel, both FDA-cleared and CE IVD marked. The BioFire offers a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. Although this test has not been FDA cleared or approved, it been authorized by FDA under an EUA for use by authorized laboratories, making them one of the reliable coronavirus (COVID-19) testing kit manufacturers in the United States.
Founded in 2007, BioMedomics is a privately held clinical diagnostics company located in Morrisville, North Carolina. The company combines biology, biochemistry, and biomedical engineering to merge advanced technologies with novel point-of-care diagnostic platforms.
BioMérieux has been a global leader in vitro diagnostic for over 55 years. The company operates in 44 countries around the globe and serves more than 160 countries with the support of a large network of distributors. The company’s subsidiary, BioFire Defense, is one of the coronavirus (COVID-19) test kit manufacturers in the US that has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2. They claim that their testing kits are extremely easy to use, therefore requiring minimal training and skills in molecular biology. This feature sets them apart from most of the other coronavirus (COVID-19) test kit manufacturers in the United States.
The Communicable Disease Center (CDC) is one of the major operating components of the Department of Health and Human Services and is recognized as the nation’s premier health promotion, prevention, and preparedness agency. It is aggressively responding to the global outbreak of COVID-19 and the community spread in the United States. CDC is also playing a critical role in minimizing the coronavirus (COVID-19) impact on procurement of healthcare supplies by working with supply chain partners to understanding supply usage, evaluating the products available, and identifying when more aggressive measures may need to be taken to ensure that healthcare workers at highest risk have access to PPE .
Cepheid was founded in 1996 with a vision to develop an innovative system that simplified a highly complex, multi-stage process for the detection and analysis of nucleic acids. Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test claims to provide rapid detection of COVID-19 virus in as soon as 30 minutes for positive results with less than a minute of hands-on time to prepare the sample, making them one of the top rapid coronavirus (COVID-19) test kit manufacturers in the US.
Chembio diagnostics was founded in the year 1985. The company is dedicated to delivering exceptional products that provide ease of use, and rapid and accurate results at the point-of-care (POC). The company is one of the emerging coronavirus (COVID-19) test kit manufacturers. They have recently launched their DPP COVID-19 IgM/IgG System in the US which claims to provide test results in 15 mins from a simple finger stick.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures, and markets a new, state-of-the-art diagnostics technology. It also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers. The company which has a unique, patented platform for the development of diagnostic test, has recently released COVID-19 test performance data that claims to demonstrate 100% sensitivity and 100% specificity.
Located in San Diego County, California, an area popular for biotechnology and scientific discovery, CTK Biotech specializes in developing and manufacturing innovative immunodiagnostic tools and point of care diagnostic test kits for the IVD community worldwide. With cases of coronavirus COVID-19 disease rising at an unprecedented rate, CTK has taken their proven strength in developing infectious disease diagnostics and in collaboration with its partners in China, has launched two diagnostic tests for this virus. This includes a real-time PCR based nucleic acid detection kit and a serological rapid screening test, for the International market. Launching two different diagnostic methodologies have made CTK biotech one of the most agile and thoughtful coronavirus (COVID-19) test kit manufacturers in the US.
Danaher is a global science and technology innovator that specialized in diagnostics, life sciences, and environmental and applied solutions. The company has several operating companies such as Beckman DX, Cepheid, Chemtreat, Cytiva, and IDT directly involved in the fight against COVID-19, making them one of the most rapid coronavirus (COVID-19) test kit manufacturers in the United States.
DiaSorin is an Italian multinational Group and a global leader in the market for in-vitro diagnostics. For over 40 years, DiaSorin has been playing a pivotal role in developing, producing, and commercializing diagnostic tests for a wide range of clinical areas. Their tests are designed for hospital and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics. One of the upcoming coronavirus (COVID-19) test kit manufacturers in the US, DiaSorin’s response to COVID-19 continues through several research projects. The company announced in April 2020 that it has CE Marked the new LIAISON® SARS-CoV-2 S1/S2 IgG serological test which has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
Epitope Diagnostics Inc. (EDI) develops and manufactures in-vitro diagnostics (IVD) products for the global research, pharmaceutical, and healthcare community. Over the years, the company has developed and launched many rapid test kits that meet the needs of healthcare communities. This makes the company a prominent name among the coronavirus (COVID-19) test kit manufacturers in the US. Epitope Diagnostics has recently introduced immunoassay kits exclusively for the qualitative detection of COVID-19. These coronavirus COVID-19 testing kits have proven results from clinical testing in China.
Established in 1909, Grifols is a global healthcare company and one of the largest plasma companies worldwide. The company recently entered into a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients, process this specific plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease.
Hologic is among the coronavirus (COVID-19) test kit manufacturers in the US who have contributes dramatically to meeting the world’s acute need for more COVID-19 detection. To navigate the coronavirus (COVID-19) impact on procurement of testing kits, the company is regressively raising production capacity for the new assay. In March 2020, Hologic received Emergency Use Authorization from the FDA for their first COVID-19 test, the Panther Fusion SARS-CoV-2 assay.
IDT has been a leader in life sciences research for 30+ years. IDT is one of the first coronavirus (COVID-19) test kit manufacturers in the United States to have their primer and probe kits approved by the CDC for use as a key component of the CDC EUA testing protocol for the diagnosis and detection of COVID-19.
LabCorp is a global life sciences company that is headquartered in Burlington, North Carolina. The company is committed to guiding patient care through its comprehensive clinical laboratory and end-to-end drug development services. The company has been actively involved in COVID-19 support measures with a high focus to protect the health of its patients, employees, and communities.
Liferiver is a PCR-based molecular diagnostics solution provider, primarily involved in developing, manufacturing & marketing real-time PCR diagnostic kits as well as instruments. The company’s products are available in more than 70 countries worldwide. Liferiver Biotech was one of the first coronavirus (COVID-19) test kit manufacturers to introduce their Novel Coronavirus Real-Time RT-PCR Kit into the market.
In response to the global outbreak of the novel coronavirus disease (COVID-19), Luminex has developed multiple solutions to enhance their NxTAG® and ARIES® offerings in order to automate and facilitate the detection of coronavirus. The company is one of the successful coronavirus (COVID-19) test kit manufacturers in the US. They have developed the NxTAG® CoV Extended Panel, which can detect COVID-19, and have received Emergency Use Authorization (EUA) from the US FDA and Medical Device Authorization for Importation or Sale for Health Canada.
A relatively new player among coronavirus (COVID 19) test kit manufacturers, LumiraDx was founded in the year 2014. LumiraDX and Chembio recently announced their COVID-19 strategic partnership to develop point-of-care diagnostic tests for the detection of the COVID-19 virus.
Mesa Biotech has developed a qualitative, visually read test utilizing polymerase chain reaction (PCR) technology to detect SARS-CoV-2, the virus responsible for COVID-19. The company is among the few coronavirus (COVID-19) test kit manufacturers that claim to provide results in 30 minutes.
NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company, is focused on providing high throughput testing solutions to hospital and commercial reference laboratories. The company recently announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.
PerkinElmer is headquartered in Waltham, MA. The company focuses on delivering unique solutions in diagnostics, life sciences, food, and applied markets. During the ongoing COVID-19 crisis, it has secured a place among the coronavirus (COVID-19) test kit manufacturers in the US. The PerkinElmer chemagic™ Viral DNA/ RNA 300 Kit H96 and the chemagic™ 360 instrument claims to offer fast, high-quality RNA extraction for use in PCR based detection of SARS-CoV-2.
Primer Design, a company focused on the design, manufacture, validation, and supply of real-time PCR kits, was founded in the year 2005. The company became part of the became part of the Novacyt Group in 2016. Primer Design is one of the emerging coronavirus (COVID-19) test kit manufacturers.
Qiagen is a leading provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research. The company emerged as one of the most prominent coronavirus (COVID-19) test kit manufacturers in the US as their QIAstat-Dx test kit received U.S. FDA EUA. It claims to be the first syndromic solution integrating detection of SARS-CoV-2 coronavirus.
Quest Diagnostics is one of the top coronavirus (COVID-19) test kit manufacturers in the US that have put up a strong force to help the country combat the pandemic. In April, the company launched IgG antibody serology testing by blood draw to help patients and healthcare professionals identify who may have been previously exposed to the SARS-CoV-2 virus.
Quidel is a well-known provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems. In March 2020, the company became one of the first coronavirus (COVID-19) test kit manufacturers that received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Lyra® SARS-CoV-2 Assay. It is a real-time RT-PCR test that is intended for the qualitative detection of nucleic acid from SARS-CoV-2. in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider.
Roche is one of the world’s largest biotech companies that leads the industry in the development of diagnostics products for cancer, cardiac health, infectious diseases, women’s health and in diabetes management. The company’s antibody test recently received FDA Emergency Use Authorization. The company is also playing a vital role in combating coronavirus (COVID-19) impact on procurement and availability of testing kits by providing high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorization, further ramping up capacities thereafter.
Sherlock Biosciences focuses on catering to unmet needs in infectious disease, oncology, agriculture, and other areas to transform diagnostic testing and global public health. The company is developing the most advanced platforms in molecular testing to offer unparalleled breadth and versatility for diagnostic solutions. Sherlock Biosciences and San Francisco-based Mammoth Biosciences and a handful of associated academics are working to make CRISPR-based diagnostics a reality.
Thermo Fisher Scientific Inc. is the world leader in serving science. The company’s thermo scientific tecnai spirit was used transmission electron microscope was used to characterize the COVID-19 pathogen in January 2020. The company also played a pivotal role in minimizing the coronavirus (COVID-19) impact on procurement of testing kits by fast-tracking and shipping over 1200 boxes of reagents and assays so that researchers could rapidly develop tests. The company’s real-time PCR test, which diagnoses the virus within 4 hours was approved by the U.S. FDA for emergency use. It also received the CE mark in Europe and now nearly 50 countries are authorized to use the test.
Wadsworth Center is a science-based community committed to protecting and improving the health of New Yorkers through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs.
XCR Diagnostics, Inc. (XCRDx) was founded in the year 2015 with the goal of developing and delivering a simple, easy to use system to the molecular diagnostic near-patient testing market. The Xtreme Chain Reaction (XCR®) test from XCR Diagnostics takes approximately 30 minutes on the same standard laboratory equipment, accelerating the laboratory’s testing capabilities. The company is one of the few coronavirus (COVID-19) test kit manufacturers to offer test results within 30 minutes. While the world is battling with the coronavirus (COVID-19) impact on procurement of testing kits, XCR Diagnostics in supplying large volumes of tests to healthcare providers.
Xiamen Aode Biotechnology Co., Ltd. was established in 2014. The company is focused on professional research and development, production and sales of rare earth nano-fluorescence immunoassay analyzer and supporting kits and provides third-party medical testing.
Beijing Applied Biological Technologies Co., Ltd. is a molecular diagnostic enterprise specializing in the development of detection solutions for pathogenic microbes. The company is headquartered in the Zhongguancun Life Science Park in Beijing.
Beijing Kewei Clinical Diagnostic Reagent Inc was formerly known as Beijing Kewei Clinical Diagnostic Reagent Factory. It is a military specialty hospital for infectious diseases, bringing together many well-known domestic clinical and diagnostic experts and professors.
Founded in December 2007, Microread Genetics is headquartered in Zhongguangcun Science and Technology Park, Haidian District, Beijing. The company is one of the top Coronavirus (COVID-19) test kit manufacturers in China. The company recently announced its molecular diagnostic kit COVID-19 (SARS-CoV-2) Detection Kit (LAMP).
Beijing Tigsun Diagnostics Co,.Ltd. was founded in 2004. The company is headquartered in the capital city of Beijing and specializes in the field of medical test. It is a high-tech enterprise integrated with the R & D, production, operation and sales of China’s professional chemiluminescence in vitro diagnostic products. One of the prominent Coronavirus (COVID-19) test kit manufacturers and suppliers in China, Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibodies in human whole blood, serum and plasma sample. This diagnostic test kit is to be used as an aid in the clinical diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.
Beijing Wantai is one of the leading manufacturers of infectious disease diagnostics. The company’s subsidiary Innovax is dedicated to providing high quality and affordable innovative vaccines for people in need to combat infectious diseases. A prominent name among the emerging Coronavirus (COVID-19) test kit manufacturers in China, Wantai serology and molecular kits for screening and confirmation of COVID-19 offer test results in under 75 minutes. This has helped China to minimize the Coronavirus (COVID-19) impact on procurement of testing kits.
CapitalBio Technology Co., Ltd. develops and commercializes total health-care solutions. CapitalBio Technology Co., Ltd. The nucleic acid test kit for coronavirus, jointly developed by CapitalBio Corporation, Tsinghua University and West China Hospital of Sichuan University, can detect six common respiratory viruses including novel coronavirus within 1.5 hours by collecting samples of patients’ oral and pharyngeal secretions.
DAAN Gene Co., Ltd. of Sun Yat-sen University was established in 1993. The company is actively involved in R&D, production and service of in-vitro diagnostic products, including qPCR, Sequencing, TRF, ELISA and Liquid Based Cytology diagnostic kits and equipment. The headquarters of the company is located in Guangzhou Science Park, Guangzhou, China.
One of the first Coronavirus (COVID-19) test kit manufacturers in China to develop and supply diagnostic kits, the company recently announced their SARS Coronavirus Fluorescence Polymerase Chain reaction (PCR) Diagnostic Kit to detect Coronavirus.
Dynamiker Biotechnology (Tianjin) Co., Ltd. was founded in early 2014. It is a high-tech enterprise integrated with R&D, production, and sales globally. The company has developed proven diagnostic criteria, to assist the diagnostic of COVID-19 – the 2019-nCOV IgG/IgM antibody test. The company is one of the Coronavirus (COVID-19) test kit manufacturers in China that has received the CE mark approval.
Getein Biotech is an in-vitro diagnostic company that specializes in analytical medical devices, point-of-care testing kits. With over 15+ years of expertise, the company’s extensive product line includes cardiovascular, inflammatory, diabetes, fertility, renal, liver, and specialty assays among many others. The company is now one of the emerging Coronavirus (COVID-19) test kit manufacturers in China that are actively working to minimize the coronavirus (COVID-19) impact on procurement of testing kits.
Hybribio is a leading supplier of nucleic acid molecular diagnostic products in China, with a complete operation chain, from research and development, production, to sales. The company is among the top Coronavirus (COVID-19) test kit manufacturers in China whose rapid testing kits help meet the detection and diagnostics of COVID-19. While the coronavirus (COVID-19) impact on procurement of testing kits is majorly affecting healthcare organizations, testing kit manufacturers like Guangdong Hybribio Biotech are actively working to improve the distribution and supply of their diagnostic kits to healthcare providers.
Biotest is specialized in vitro diagnostic reagents and equipment research and development, manufacturing, sales and service as one of the national high-tech enterprises. The company is one of the few Coronavirus (COVID-19) test kit manufacturers whose diagnostic kits claim to offer accurate test results within ten minutes.
Innovita is one of the noted Coronavirus (COVID-19) test kit manufacturers in China. They have developed an AB test (Colloidal Gold) that is used for the qualitative detection of SARS-CoV-2.
Another well-known name among the Coronavirus (COVID-19) test kit manufacturers in China, InTec PRODUCTS , have recently launched a rapid immunoassay for the qualitative detection of IgM and IgG antibodies to the virus SARS-CoV-2 for patients with signs and symptoms of COVID-19 disease.
Jiangsu ZECEN Biotechnology Co., Ltd (Hereinafter referred to as ZECEN BIOTECH) is an IVD manufacturer that takes full auto chemiluminescence analyzer and CLIA reagent kits as its main products.
Established in 2001, Liming Bio-Products Co., Ltd. specializes in developing, manufacturing, and marketing rapid tests for infectious diseases, especially STDs. The company is one of the Coronavirus (COVID-19) test kit manufacturers in China and has recently announced their Multiplex Real-Time PCR kits for the detection of SARS-CoV-2.
Macura Biotechnology researches and develops clinical IVD products. Another well-known name among the Coronavirus (COVID-19) test kit manufacturers in China, Maccura Biotechnology has announced their SARS-CoV-2 Fluorescent PCR Kit is a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 viral nucleic acids in upper respiratory specimens (e.g., oropharyngeal swabs, nasopharyngeal swabs, nasal swabs, and mid-turbinate swabs).
Medicalsystem Biotechnology Co., Ltd. was founded in 2003 in Ningbo. During the coronavirus outbreak, the company was one of the Coronavirus (COVID-19) test kit manufacturers in China that have actively engaged in the production and distribution of diagnosis kits.
EGENS GROUP develops, manufactures, and distributes diagnostic kits worldwide, with manufacturing sites in Beijing, Nantong, and Wuxi. The company is one of the Coronavirus (COVID-19) test kit manufacturers in China.
Sansure was founded in the year 2008. The company is among the top (COVID-19) test kit manufacturers in China whose testing kits have received certifications including CE-IVD, NMPA, FDA-EUA.
Sinopharm Group Shanghai Jienuo Biotechnology Co., Ltd. is a subsidiary of China National Pharmaceutical Group Corporation China Biotechnology Co., Ltd. The company is primarily involved in the sale of medical devices and in vitro diagnostic reagents. The company is one of the (COVID-19) test kit manufacturers in China whose IVD test- Novel Coronavirus 2019-nCoV RTPCR Kit (Fluorescent PCR method) was recently approved.
Liferiver is a leading PCR-based molecular diagnostics solution provider, developing, manufacturing & marketing real time PCR diagnostic kits as well as instruments. The company is one of the emerging (COVID-19) test kit manufacturers in China.
BioSewoom Inc. is a Korean company that specializes in molecular diagnostics. The company is one of the coronavirus (COVID-19) test kit manufacturers in South Korea who are mass producing their in-vitro diagnostic kits to be exported to international countries to help fight the COVID-19 pandemic.
Bioneer was the first Korean biotechnology company when it was established in 1992. With two production facilities in South Korea, the company has successfully developed several molecular biology products and technologies including oligonucleotides, thermostable polymerases, and instruments of gene manipulation (automatic nucleic acid extractor, thermal cycler, real-time QPCR instruments and DNA sequencer).
With over 20 years of expertise in developing products for in-vitro diagnostics and diagnostic reagents, the company is exploring new markets through the automation of on-site diagnosed immunodiagnostic devices and the development of new high-sensitive diagnostic reagents. Their ichromaTM COVID-19 AB test system is a rapid in-vitro diagnostic test that qualitatively detects anti-SARS-CoV-2 IgG/IgM antibodies in the whole blood, serum or plasma samples with high sensitivity.
CancerRop is one of the top molecular diagnostics company is South Korea. It was founded in the year 2001. The company recently acquired CE-IVD (Conformite Europeen In-vitro Diagnostic Device) certification as well as export approval from the Ministry of Food and Drug Safety for its Q-Sens 2019-nCoV diagnostic kit. CancerRop is among the coronavirus (COVID-19) test kit manufacturers in South Korea who are helping combat the coronavirus (COVID-19) impact on Procurement and supply of testing kits in international markets by scaling up their exports and adhering to strict quality control requirements.
DowGene DNA Testing Company Co., Ltd. develops and provides DNA-related services and products. Their product and service portfolio includes DNA profile tests for paternity verification, kinship verification, individual identification, remains identification, DNA profile tests for prevention of missing children, food foreign substance detection and kind identification tests, DNA analysis services and DNA storage cards. The company is one of the nineteen coronavirus (COVID-19) test kit manufacturers that recently received the export nod for PCR agents, including reverse-transcription PCR (RT-PCR) kits.
The company was founded in the year 2012. GenBody Inc. creates innovative technologies for the development of raw materials for diagnostic use. They also offer diagnostic total solution such as rapid diagnostic tests (RDTs), fluorescent immuno-diagnostic tests, ELISA, molecular diagnostic tests (MDx) and clinical chemistry.
GeneMatrix Inc is a Korean company servicing molecular diagnostics. The company offers medical products and services that help clinicians analyze, diagnose, and treat their patients. Their leadership team has more than 65 years of healthcare industry experience working directly with clinicians and physicians. GeneMatrix is one of the prominent coronavirus (COVID-19) test kit manufacturers in South Korea. Thhey recently announced their winning of the CE-IVD certification for its new coronavirus test kit, NeoPlex COVID-19. To overcome the coronavirus (COVID-19) impact on procurement and supply, the company is preparing to scale up their production if demand soars.
The company was founded in the year 2000 and is known for being a rapid test kit company. Their fields of R&D include female hormone test, acute myocardial infarction test, virus infectivity test, and cancer test. The company is one of the prominent coronavirus (COVID-19) test kit manufacturers in South Korea. Humasis COVID-19 IgG/IgM Test, an antibody test kit, has been registered with the U.S. Food and Drug Administration. The company is all set to help the US combat the coronavirus (COVID-19) impact on procurement and supply of testing kits by increasing their exports to the country. Apart from the this, the company has been contracting or planning to do so to supply about 3 million test kits with various countries, including Brazil, Germany, the U.K., and France.
iNtRON Bio has been focusing on the R&D investment since its foundation. They are also developing diagnostic kits for various diseases. The company is currently one of the top coronavirus (COVID-19) test kit manufacturers in South Korea. Their LiliF™ COVID-19 Real-time RT-PCR Kit can detect the novel coronavirus using probe method of Real-time RT-PCR, through the reacting of the specific primer and Fluorescent probe in sample.
KH Medical is Manufacturer and Supplier of Diagnostic Products founded in Seoul, South Korea. The company recently announced that they received CE marking for their “RADI COVID-19 Detection kit (Ref: RV008)” for detection of SARS-CoV-2 (the causative agent of COVID-19).
Since KogeneBiotech’s inception in 2000, they have earned a reputation for innovation in Molecular Diagnostics. Their primary business units include production of Real-time PCR/conventional PCR Kit based on the active R&D works and Testing Service for Food and Human. The company currently produces around 400 PCR and Real-time PCR Kits and the great part of these products are developed by Government’s grant and collaboration with national research institute. Their PowerChekTM 2019-nCoV Real-time PCR kit claims to provide fast and accurate testing solution for COVID-19.
LabGenomics is a healthcare company that specializes on molecular diagnostics through new and effective diagnostics methods related to various diseases. During, the COVID-19 outbreak, the company has played a pivotal role in developing testing kits, making them one among the successful coronavirus (COVID-19) test kit manufacturers in South Korea. The company’s LabGunTM COVID-19 RT-PCR Kit is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2.
MiCo Biomed was founded in 2009. They actively collaborate with universities and government agencies to create innovative technologies of tomorrow. The company has also merged with other organizations in order to expand their line-up of diagnostics products to include biochemical and immunological. The company is also playing a critical role to help navigate the coronavirus (COVID-19) impact on procurement of testing kits. Edmund Optics and MiCo BioMed Co. Ltd. have collaborated on a highly sensitive molecular diagnostic device, the VERI-Q PCR 316, that is capable of detecting COVID-19 within an hour.
Osang healthcare is involved in the development of comprehensive solution for medical device infrastructure, utilizing high-tech blood-based medical diagnostic sensors, medical devices and a digital health platform was one of the first coronavirus (COVID-19) test kit manufacturers in South Korea to get the U.S. Food and Drug Administration’s approval for emergency use of the test kit.
PaxGenBio Co., Ltd. (Bio-company of Peaceful Gene), was established in 2015 as a molecular diagnostics company that develops, manufactures, and markets a portfolio of IVD products targeting infectious diseases and cancers. The company is one of the few coronavirus (COVID-19) test kit manufacturers that offer real-time RT-PCR kits.
SD BIOSENSOR has successfully launched diagnostics of blood glucose, glycated hemoglobin, and cholesterols globally. The company is one of the top coronavirus (COVID-19) test kit manufacturers in South Korea. The company has also received US FDA approval for their STANDARD M nCoV Real-Time Detection Kit that is used for rapid diagnosis of the novel coronavirus.
SEASUN BIOMATERIALS provides easy-to-use, highly sensitive solutions for diagnosing genetic disorders and cancer genome from your liquid biopsy samples. The company is one of the coronavirus (COVID-19) test kit manufacturers in South Korea to have received the FDA authorization under EUA for their testing kits.
ATI biotech was founded in 2008. The company is a leading Molecular Diagnostic (MDx), Molecular Services and Life Science Products provider in Singapore and ASIA. The company is also a world leader in multiplex real-time PCR (qPCR) assays for tropical infectious diseases.
Incorporated in 2009, Biolidics Limited is a precision medicine medical technology company that is focused on developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes. One of the key coronavirus (COVID-19) test kit manufacturers in Singapore, Biolidics Limited claims that their test kits can produce rapid results within 10 minutes.
DSO National Laboratories (DSO) is Singapore’s largest defense research and development (R&D) organization. They emphasize on developing technological solutions to sharpen the cutting edge of Singapore’s national security. The company was established in 1972.
Everest is a Singapore and Malaysia based company with 12 years of market presence. The company specializes in distributing, installing, servicing, and decommissioning of specialized Oncology and diagnostic solutions for hospitals and research facilities.
JN Medsys is a life sciences company headquartered in Singapore. During the time of the coronavirus outbreak, the company has been one of the top coronavirus (COVID-19) test kit manufacturers in Singapore. The company unveiled its ProTect™ Covid-19 RT-qPCR test, which is a nucleic acid test that identifies the RNA of the virus isolated from patient samples using reverse transcription-polymerase chain reaction (RT-PCR).
The company has announced their COVID-19 Rapid IgG/IgM combined Antibody assay Pre-screening test Kit with a result time of 10 minutes. Their pre-screening test kit can test for two antibodies IgM and IgG simultaneously with over 92% accuracy.
Veredus Laboratories is a biotechnology company that markets, develops, and customizes innovative solutions for the detection of pathogens. In this COVID-19 pandemic, Veredus has available resources to support with meeting demands for clinical testing. Starting from viral RNA extraction to molecular assay for the detection of SARS-CoV-2, they possess a comprehensive diagnostic solution. Alternatively, they are one of the coronavirus (COVID-19) test kit manufacturers offering solutions for rapid detection using serological testing.
Altona Diagnostics has over 20 years of experience in molecular diagnostics, focusing on real-time PCR and other relevant technologies. Altona Diagnosis is headquartered in Hamburg, Germany. The company is one of the top coronavirus (COVID-19) test kit manufacturers in Germany whose CE-IVD certified RealStar® SARS-CoV-2 Virus RT-PCR Kit 1.0 consists of Master Reagents, Positive Control and an Internal Control and claims to deliver highly reliable results. It is designed as a dual target assay and allows rapid screening of all lineage B-betacoronaviruses and confirms the presence of SARS-CoV-2 specific RNA in only one reaction.
Servoprax is one of the largest medical products wholesalers in Europe. The company was established in the year 1978. During the COVID-19 crisis, the company has been one of the coronavirus (COVID-19) test kit manufacturers in South Korea that is constantly working to navigate the coronavirus (COVID-19) impact on procurement and supply of their goods and services.
Since 1990, TIB MOLBIOL has been providing custom synthesis of oligonucleotides to a growing number of customers worldwide. The company’s products are being used in a number of fields such as life science research, medical diagnostics, product quality assessment and environmental analysis. TIB MOLBIL was also one of the first suppliers of synthetic DNA in Europe.
Anatolia is an international biotechnology company that operates under ISO 9001, ISO 13485, and 98/79/EC Full Quality Assurance Systems. The company’s primary expertise includes designing, developing, and manufacturing Real-Time PCR kits, nucleic acid extraction kits and automated nucleic acid extraction instruments. The company is one of the prominent Coronavirus (COVID-19) test kit manufacturers in Turkey. Their Bosphore® coronavirus Panel Kit v1 is, a Real-Time PCR-based in vitro diagnostic medical device, IVD CE marked according to 98/79/EC Directive. Bosphore® coronavirus Panel Kit v1 detects and characterizes coronavirus 229E, coronavirus HKU1, coronavirus OC43 and coronavirus NL63 in human respiratory samples.
CerTest Biotec, S.L. is an independent biotechnology company devoted to the development and manufacturing of IVD diagnostic products in human clinical field. Known to be one of the key Coronavirus (COVID-19) test kit manufacturers in Spain, CerTest Biotech has recently announced their VIASURE SARS-CoV-2 Real Time PCR Detection Kit that is available only for professional use. The company is also playing an active part in minimizing the coronavirus (COVID-19) impact on procurement of testing kits by shipping their COVID-19 testing kits anywhere in the world without the need for a cold chain, or storage at room temperature using the lyophilization process.
GENOMICA is the first Spanish company in Molecular Diagnostics and highly experienced in the analysis of genetic identification. The company has developed diagnostic test for human papillomavirus associated with cervical cancer, the diagnosis of viral respiratory diseases, multiple detection of human herpes and enteroviruses, as well as detection of gene regions associated to the determination of human therapy response factors, in particular in the Oncology field. A well-known name amidst the Coronavirus (COVID-19) test kit manufacturers in Spain, GENOMICA SAU has developed and sells two SARS-CoV-2 diagnostic kits. These kits are said to produce results from patient samples in less than 5 hour
AusDiagnostics Pty Ltd is the major supplier of Highly Multiplexed molecular diagnostics in Australia with offices also in London, Dallas, and Auckland. The company is one of the top Coronavirus (COVID-19) test kit manufacturers in Australia. AusDiagnostics recently announced that it has developed a molecular diagnostic test to detect the new coronavirus (2019-nCoV, or Wuhan coronavirus) based on its nucleic acid sequence.
With over 25 years of experience, Mobius Life Science develops and commercializes products for the diagnostic medicine segment, provides kits for nucleic acid extraction, serology and also for in vitro molecular diagnosis of infectious diseases, oncology, and genetics. The company is playing an active part in minimizing the coronavirus (COVID-19) impact on procurement by developing testing kits. Mobius announced the launch of their XGEN MASTER COVID-19 Kit that uses the CDC China protocol, with detection of the ORF1ab and N genes for SARS-CoV-2.
Vyttra is known to be one of the largest Brazilian companies engaged in the manufacture and distribution of equipment and reagents. The company is among the first Coronavirus (COVID-19) test kit manufacturers in Brazil. Their Smart Test Anti Covid-19 is fast and makes use of the immunochromatographic methodology for the qualitative detection of coronavirus IgM and IgG antibodies in serum, plasma, or whole blood.
Mylab provides a portfolio of diagnostic kits for pathogen detection and viral load monitoring. Complete validated and FDA approved workflows provide standardized and reliable solutions for routine testing. Automation with the Compact x integrates automated sample preparation and assay setup with detection maximize your efficiency and optimize your workflows, from sample to result. The company is one of the first Coronavirus (COVID-19) test kit manufacturers in India to get commercial approval from the CDSCO. The company which specialized in developing molecular diagnostic kits has developed the first made in India test kits Mylab PathoDetect COVID-19 Qualitative PCR. They have played a pivotal role in easing the coronavirus (COVID-19) impact on procurement of testing kits in India by providing them at a much lower rate.
BioMaxima S.A. is a Polish company listed on NewConnect stock market, producer of microbiology media as well as a wide range of reagents and in vitro diagnostics equipment. The company is also a distributor of products of recognized global diagnostics companies such as Nova Biomedical, Mitsubishi Chemical, Biologist. After the coronavirus outbreak, the company has announced several testing kits to detect SARS-CoV-2.
Dawid Nidzworski, a Doctor of Biological Sciences specializing in Biochemistry, together with Artur Kupczunas, Piotr Krych and Tomasz Gondek, established SensDx (formerly Eton Group) in September 2014. The company is now among the prominent Polish Coronavirus (COVID-19) test kit manufacturers who have developed their own testing kits to help minimize coronavirus (COVID-19) impact on procurement of diagnosis kits. The SARS-CoV-2 SensDx assay provides rapid testing solution for clinical and non-clinical setting during COVID-19 pandemic. The assay is designed for professional use by medical or paramedical personnel.
The company was established in June 2000 as a single proprietorship then known as Lifeline Diagnostics Supplies. Over the years, the company expanded its operations and is now one of the Top 4,000 Corporations in the Philippines.
Founded in 1987, Clonit srl was one of the first biotechnology companies in Italy. The company is actively involved in the development of innovative and reliable analytical techniques in the field of In Vitro diagnostics using molecular biology techniques. Clonit is a major coronavirus tes7t kit supplier in Italy. The company has announced the quanty COVID-19 kit CE-IVD which is helping Italy combat the coronavirus (COVID-19) impact on procurement of diagnostic kits. The quanty COVID-19 allows the detection and quantification of the COVID-19 genome using Multiplex PCR, according to the CDC indications.
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