Coronavirus Recent Updates

Moderna Vaccine’s Progress, Excites COVID-19 Markets

Moderna Inc’s experimental COVID-19 vaccine, the first to be tested in the United States, produced protective antibodies in a small group of healthy volunteers. However, the data comes from eight people who took part in a 45-subject safety trial that kicked off in March. Afterward, Phase I trial results of the vaccine, mRNA-1273, have been found promising. On May 7, the company has received regulatory clearance for the Phase II trial that would involve a much larger sample size. The imminent Phase II study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase III study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. In addition, Moderna launched a $1.34 billion share offering at an offer price of $76 per share. The company had earlier said it plans to sell $1.25 billion in common stock to raise money for vaccine development and manufacturing.

Canada Approves the First Clinical Trial for potential Covid-19 Vaccine

The race is on to find a vaccine for COVID-19 and Canada’s government may have taken the lead after its national drug regulator cleared a plan to begin studying the front-running candidate. This investigation drug is an adenovirus-based vaccine developed jointly by China’s CanSino Biological and the National Research Council of Canada and is one of eight to have made it to the clinic, and is already in phase II development in China. 

Gilead Signs Licensing Agreement With Cipla, Jubilant Life, Mylan, Hetero Labs & Ferozsons Labs

Gilead signed non-exclusive licensing agreements with five companies based out of India and Pakistan for their investigational drug remdesivir, to treat COVID-19 patients. Gilead signed licenses with Cipla, Jubilant Lifesciences, Hetero Labs, Mylan, and Ferozsons Labs. Under the agreement for remdesivir, Gilead would transfer its technology on how the API and formulations are developed to the companies and distribute it in 127 countries including India.

The deal would ensure accessibility and affordability of remdesivir in especially lower income countries with poor health infrastructure. Besides India, this license agreement extends to countries such as Afghanistan, Bhutan, Cambodia, South Africa and Egypt to name a few. It does not extend to larger and more developed countries such as US, UK, Europe, China, Australia amongst others. Hence, the drug was given emergency use authorization (EUA) by the USFDA for treating COVID-19 patients, but is yet to be formally approved by the drug regulator. Further, this is the second voluntary license agreement that Gilead has signed.

China Tests Coronavirus Drug That Aims to Stop Pandemic Sans Vaccine

A Chinese laboratory has been developing a drug it believes has the power to bring the coronavirus (COVID-19) pandemic to a halt. A drug being tested by scientists at China’s prestigious Peking University could not only shorten the recovery time for those infected but even offer short-term immunity from the virus. It is isolated from the blood of 60 recovered patients. The drug has been successful at the animal testing stage. The injection of the neutralizing antibodies into infected mice resulted in reducing the viral load was reduced by a factor of 2,500 This potential drug has a therapeutic effect.

Oxford’s Jenner Institute & AstraZeneca Collaborate Together

Oxford’s Jenner Institute had entered into the collaboration with the AstraZeneca for the development of the vaccine. The experimental vaccine, known as ChAdOx1 nCoV-19, is one of the front runners in the global race to provide protection against the new coronavirus causing the COVID-19 pandemic.

Microsoft & UnitedHealth Launch COVID-19 Screening App For The Workplace

Microsoft and UnitedHealth Group are launching a free smartphone app that businesses and employees can use to digitally screen for COVID-19 symptoms and clear those who can return to work. Based on guidelines from the Centers for Disease Control and Prevention, the ProtectWell app uses Microsoft’s chatbot interface to ask the user a series of daily questions, such as whether they have had a fever or any respiratory symptoms or whether they’ve been in contact with anyone diagnosed with COVID-19.

Fitbit to Develop Emergency COVID-19 Ventilator

Fitbit aims to wield its fitness-focused supply chain to start building its own COVID-19 ventilator and plans to submit its designs to the FDA in the near future. This device would include more features than the typical emergency alternatives developed in response to the spreading coronavirus pandemic, which are largely made to be built quickly and at scale using off-the-shelf components and mechanically deliver puffs of air at a fixed rate. 

FDA Approved Emergency Use Authorizations (EUAs): Diagnostic Products for Novel Coronavirus Detection

Globally, the coronavirus (COVID-19) pandemic outbreak has shown a drastic impact on the diagnostic companies resulting in a shortage of reagent, new product launch, and developing a pipeline. To combat the situation, FDA has been working continuously to facilitate the development and availability of medical and diagnostic products, for use by patients, physicians, and healthcare to expedite the diagnosis process as quickly as possible.

Hence, Food and Drug Administration (FDA) provides the Emergency Use Authorizations (EUAs), to diagnostic companies to help make medical and diagnostic products available as quickly as possible to treat or diagnosis the chronic or life-threatening disease during public health emergencies.

Several companies such as Abbott Laboratories, Hologic, Quidel Corp, and Roche Diagnostics have received emergency use authorization from the Food and Drug Administration (FDA) for their COVID-19 diagnostic assays for ramping up production to help alleviate testing shortages. The molecular diagnostic tests are generally authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in specific upper and lower respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. The specific specimen types for each test can be found in the authorization letter.

Some molecular diagnostic tests may require a highly experienced expertise to manually perform the test (e.g., perform an RNA extraction step usually using specific extraction platforms and kits), while other tests are automated and require only limited training to perform). Typically, manually performed tests are authorized for use by laboratories certified to perform high-complexity tests, while automated tests are authorized for use by laboratories certified to perform moderate complexity tests and/or at the point-of-care by facilities operating under a CLIA Certificate of Waiver.

Major Companies & their Molecular Diagnostic Products

Abbott Laboratories: Abbott RealTime SARS-CoV-2 Assay

Abbott RealTime SARS-CoV-2 Assay is a real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals. It is a fully automated solution to help laboratories to address the urgent need for automated, high-volume patient testing during the Coronavirus (COVID-19) pandemic.

Luminex Molecular Diagnostics, Inc: NxTAG CoV Extended Panel

The NxTAG CoV Extended Panel detects SARS-CoV-2 detection using three viral genes (ORF1ab, E gene, and N gene). It provides sensitive and reliable results. It also provides a highly scalable and cost-effective solution.           

Altona Diagnostics: RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions)

RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions), is a reagent system, based on real-time PCR technology, for the qualitative detection and differentiation of lineage B-betacoronavirus (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. These tests can be run in parallel with RealStarInfluenza Screen & Type RT-PCR Kit 4.0.etc

InBios International, Inc: Smart Detect SARS-CoV-2 rRTPCR Kit

Smart Detect SARS-CoV-2 rRTPCR Kit is a real-time RT-PCR test for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 in human nasopharyngeal, anterior nasal, and mid-turbinate nasal swab specimens from individuals suspected of COVID-19

FDA Emergency Use Authorizations: Diagnostic Products Landscape

SPONSOR PRODUCT DESCRIPTION
Center for Disease Control and Prevention (CDC)CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Developed by CDC and initially distributed to public health labs across the country
Can only be run in high complexity labs
Wadsworth – New York State Public Health New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel   Developed by Wadsworth based on CDC’s published protocol Run in qualified labs across New York State Can only be run in high complexity labs
Roche Molecular Systems, Inc. cobas SARS-CoV-2 for use on the cobas 6800/8800 Systems Commercially distributed as a kit to labs
Can be run in moderate and high complexity labs
Life Technologies (a part of Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Combo Kit, 100 Rxn, TaqPath COVID19 Combo Kit, 1,000 Rxn Commercially distributed as a kit to labs
Can only be run in high complexity labs
Laboratory Corporation of America COVID-19 RT-PCR Test COVID-19 RT-PCR Amendment Developed and run in high complexity LabCorp labs only; not for broader lab distribution
Amendment permits use of the Pixel by LabCorp COVID-19 test home collection kit allowing patients to self-collect nasal swab specimens at home
The kit provides specimen collection materials and materials to safely mail specimens to an authorized laboratory
Hologic, Inc. Panther Fusion SARS-CoV-2 Assay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Quest Diagnostics Infectious Disease, Inc. SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR Developed and run in Quest labs only; not a kit for distribution
Can only be run in high complexity labs
Quidel Corporation Lyra SARS-CoV-2 Assay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Abbott Molecular, Inc. Abbott RealTime SARS-CoV-2 assay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test Reagents commercially distributed as a kit to labs
Can run up to 24 specimens at the same time
Can be run in a moderate or high complexity lab
DiaSorin Molecular LLC Simplexa COVID-19 Direct Reagents commercially distributed as a kit to labs
Can run 1 specimen at a time
Can be run in moderate and high complexity labs
Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR Reagents commercially distributed as a kit to labs  
Can only be run in high complexity labs
Cepheid Xpert Xpress SARS-CoV-2 test Reagents commercially distributed as a kit to labs
Can run up to 2,000 samples per day Can be run in a high or moderate complexity lab or at the Point of Care (POC) near the patient (deemed CLIA waived)
Mesa Biotech Inc Accula SARS-CoV-2 Test Reagents commercially distributed as a kit to labs
Runs one specimen at a time
Can be run in a high or moderate complexity lab or at the Point of Care (POC) near the patient (deemed CLIA waived)
BioFire Defense, LLC BioFire COVID-19 Test Reagents commercially distributed as a kit to labs
Can run up to 264 tests per day  
Can be run in moderate or high complexity labs
PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Avellino Labs USA AvellinoCoV2 test Developed and run in Avellino labs; not distributed to other labs
High complexity test limited to authorized laboratories
BGI Genomics Co. Ltd. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019- nCoV Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 Reagents commercially distributed as a kit Requires a specific platform (ID NOW), of which there are 18,000 installed across the US
Runs one specimen at a time
NeuMoDx Molecular, Inc NeuMoDx SARS-CoV-2 Assay Reagents commercially distributed as a kit
Can run 288 or 96 samples at once, depending on the instrument, and takes 80 minutes per sample
Can be run in high and moderate complexity labs
QIAGEN GmbH QIAstat-Dx Respiratory SARSCoV-2 Panel Detects multiple other respiratory viral and bacterial organisms
Reagents commercially distributed as a kit to labs
Runs one specimen at a time and takes one hour
Can be run in high and moderate complexity labs
EUA for COVID-19 LDTs Laboratory developed tests that are authorized are listed below and hyper link to letter granting inclusion under EUA Authorizes the use of LDTs that meet certain criteria
Authorized tests can be used in the high complexity CLIA-certified lab that developed the test
Ipsum Diagnostics COV-19 IDx Assay Uses commercially available reagents
Can only be run in high complexity labs by Ipsum
Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System Reagents commercially distributed as a kit to labs
Fully automated, 8 samples per hour Can be run in moderate and high complexity labs
Luminex Corporation ARIES SARS-CoV-2 Assay Reagents commercially distributed as a kit to labs
Can be run in moderate and high complexity labs
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
CoDiagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
InBios International, Inc Smart Detect SARS-CoV-2 rRTPCR Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
DiaCarta, Inc. QuantiVirus SARS-COV-2 Test Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Becton, Dickinson & Company (BD) BD SARS-CoV Reagents for BD MAX System Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Atila BioSystems, Inc. iAMP COVID-19 Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
GenoSensor, LLC. GS COVID-19 RT-PCR KIT Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay Laboratory Developed Test
High complexity test limited to KorvaLabs, Inc., a certified high complexity laboratory
Fosum Pharma USA Inc Fosun COVID-19 RT-PCR Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Trax Management Services Inc. PhoenixDx 2019-CoV Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Seegene, Inc. Allplex 2019-nCoV Assay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S. Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
SD Biosensor, Inc. STANDARD M nCoV RealTime Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Rheonix, Inc. Rheonix COVID-19 MDxAssay Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
LabGenomics Co., Ltd. LabGunCOVID-19 RT-PCR Kit Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
Bio-Rad Laboratories, Inc. Bio-Rad SARS-CoV-2 ddPCR Test Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs
BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1) Reagents commercially distributed as a kit to labs
Can only be run in high complexity labs

Novel Coronavirus: Recent Updates

Novel Coronavirus: Recent Updates

Sanofi and GSK Collaborate to Develop Vaccine for COVID-19

Sanofi and GlaxoSmithKline have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology. Sanofi would contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology whereas the GSK would contribute its pandemic adjuvant technology. The use of an adjuvant technology would help in reducing the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore help in protecting the more people.

China Approves Two Experimental Coronavirus Vaccines to enter Clinical Trials

China has approved early-stage human tests for two experimental vaccines to combat the new coronavirus. One vaccine is being developed by a Beijing-based unit of Nasdaq-listed Sinovac Biotech, and another vaccine is being developed by the Wuhan Institute of Biological Products.

AstraZeneca to Test the Impact of Cancer Drug Calquence on Coronavirus Patients

AstraZeneca is planning to start a clinical trial of its cancer drug i.e. Calquence to assess its potential to control the exaggerated immune system response associated with COVID-19 infection in severely ill patients.

Calquence (acalabrutinib) belongs to a class of drugs called Bruton’s tyrosine kinase (BTK) inhibitors which can suppress autoimmune diseases. Calquence is currently used to treat certain types of blood cancers, has already been approved for the treatment of adult patients with chronic lymphocytic leukaemia in the United States and several other countries.

Celltrion Identifies Antibody Candidates against COVID-19

Celltrion has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2, the virus causing COVID-19. Celltrion will begin cell-line development mass production of the selected therapeutic monoclonal antibody. The Company would conduct the efficacy and toxicity testing with Korea Centers for Disease Control and Prevention (KCDC) of the selected therapeutic monoclonal antibody in mice and non-human primates.

Immunomic collaborates with PharmaJet and EpiVax for COVID-19 Vaccine

Immunomic Therapeutics has entered into a collaboration with PharmaJet and EpiVax to develop a nucleic acid vaccine candidate against COVID-19. This collaboration would help in developing a vaccine that is scalable, heat-stable and easy to administer using PharmaJet’s Tropis needle-free injection system.

Vir selects Samsung Biologics to Produce COVID-19 Antibodies

Vir Biotechnology has selected South Korea-based Samsung Biologics for large-scale production of antibodies to potentially treat Covid-19. Under the terms of the collaboration, Samsung Biologics would provide the manufacturing services for Vir’s monoclonal antibody (mAb) programme targeting the novel coronavirus, SARS-CoV-2. Vir’s lead mAb candidates, VIR-7831 and VIR-7832, had showed high affinity for the spike protein of SARS-CoV-2 and ability

Eli Lilly to Begin Testing RA Drug Olumiant and an Anti-Ang2 Drug in COVID-19 Patients

Eli Lilly plans to explore the use of its rheumatoid arthritis drug i.e.,  Olumiant (oral JAK1/JAK2 inhibitor)  as a treatment for hospitalized patients with COVID-19. Olumiant (Baricitinib) is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. The clinical trial of  Olumiant for COVID-19 would begin this month and results are expected within the next two months.

Moreover, the company is planning to advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase II testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to Acute Respiratory Distress Syndrome (ARDS). Ang2 is known to be elevated in ARDS patients and Lilly will test whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients

Promising Clinical Trial Results of Gilead Sciences’ Antiviral Drug Remdesivir for COVID-19

Gilead Sciences Inc.’s experimental drug i.e. remdesivir has shown the promise results in early analysis. All the patients received remdesivir for up to 10 days on a compassionate use basis. The clinical trial demonstrated the clinical improvement was observed in 36 of 53 patients (68%) over the 18 days with 17 of the 30 patients on mechanical ventilation being able to get off the breathing device. Almost half of the patients studied were ultimately discharged, while 13% died. Mortality was highest among those who were on a ventilator, with 18% of them dying. Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy

FDA Approves Rutgers’ Saliva Test for COVID-19

The diagnostic saliva test developed by RUCDR Infinite Biologics with Spectrum Solutions and Accurate Diagnostic Labs (ADL) has received the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test involves the use of the saliva for the diagnosis of the COVID-19.

This test has eliminated the need for collecting the sample through nasopharyngeal or oropharyngeal as the current COVID 19 diagnostic test requires a swab from deep in the nasal passages or the back of the throat. It puts the healthcare workers at risk of catching an infection. The diagnostic saliva test uses easy-to-collect saliva samples instead of the more difficult deep nose swabs in comparison to the existing diagnostic tests and would reduce the risk of healthcare workers from getting the infection.

FDA Approved Drugs: February 2020

FDA Approved Drugs: February 2020

Pizensy (lactitol): Braintree Labs

Pizensy (lactitol) is an osmotic laxative therapy indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Pizensy will be supplied as a powder for oral solution as 280 grams and 560 grams of lactitol in multi-dose bottles, as well as 28 unit-dose packets each containing 10 grams of lactitol. The product can be mixed with the patient’s fluid of choice and is taken once daily, preferably with meals. Pizensy is expected to be available in the United States in H2 2020. Pizensy is a New Chemical Entity and is expected to have patent protection until 2037.

Nexletol & Nexlizet (bempedoic acid and ezetimibe): Esperion Therapeutics

Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Nexletol will be commercially available in the United States by March 30, 2020. Nexlizet is a combination of an adenosine triphosphate-citrate lyase (ACL) inhibitor, bempedoic acid, and ezetimibe, a cholesterol absorption inhibitor. The FDA approval of Nexletol and Nexlizet provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease. High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems.

Barhemsys (amisulpride):Acacia Pharma

Barhemsys is the first and only antiemetic approved therapy for the ‘rescue treatment’ (patients who are uncontrolled following prophylactic treatment with standard-of care-antiemetics) and prophylaxis of Postoperative Nausea and Vomiting (PONV) in patients who have failed prior prophylaxis using current standard of care. It is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL).

Nurtec ODT (rimegepant):Biohaven Pharmaceuticals

Nurtec ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).The approval of Nurtec ODT was based on efficacy data from a randomized, double-blind, placebo-controlled Phase III trial that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Nurtec ODT will be supplied as 75mg orally disintegrating tablets in a blister pack of 8 and is expected to be available in early March 2020.

Novel Coronavirus (COVID-19) Recent Updates

Novel Coronavirus (COVID-19) Updates

FDA Approves First Rapid Point-Of-Care COVID-19 Diagnostic Test

Sunnyvale-based molecular diagnostic company Cepheid received FDA approval for the first rapid coronavirus test with a 45-minute detection time. This test will be used primarily in hospitals and emergency rooms.

Abbott receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

Abbott has received FDA emergency use authorization for a molecular test for novel coronavirus (COVID-19). The Abbott m2000 RealTime System is a molecular solution featuring a broad menu of tests, including ones for infectious diseases. The platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece (or few copies of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently used in labs around the world.

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across the US to begin patient testing under FDA Emergency Use Authorization

Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the FDA Emergency Use Authorization (EUA). The Cobas SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for the improved management of COVID-19 patients and to reduce the risk of SARS-CoV-2 (coronavirus) infection. These highly automated tests provide results in 3-½ hours.

Eli Lilly teams with Indiana Health Agency to provide speedy Coronavirus Testing to Indiana Residents

Eli Lilly teams with the Indiana State Department of Health (ISDH) to rapidly expand and accelerate testing for the SARS-CoV-2 coronavirus in Indiana.

Thermo Fisher plans to produce up to 5 million of a new test to detect the Novel Coronavirus

Thermo Fisher, the largest maker of scientific tools, plans to produce up to 5 million of a new test to detect the novel coronavirus that causes Covid-19. The Food and Drug Administration granted the new test an emergency use authorization status.

*Emergency Use Authorization (EUA): Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.