Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

QIAGEN Releases Coronavirus Test Kit In US On New FDA Policy

By Zacks Investment ResearchStock MarketsMar 26, 2020 06:19AM ET
www.investing.com/analysis/qiagen-releases-coronavirus-test-kit-in-us-on-new-fda-policy-200519421
QIAGEN Releases Coronavirus Test Kit In US On New FDA Policy
By Zacks Investment Research   |  Mar 26, 2020 06:19AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 

QIAGEN N.V. (NYSE:QGEN) announced that it started shipping its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test (which is to be sold as an in-vitro diagnostic or IVD) in the United States to help diagnose coronavirus-infected patients. The announcement came after a new policy of an Emergency Use Authorization (EUA) was declared by the FDA early this month. Notably, the company will submit the related EUA to the FDA this week.

Per QIAGEN, QIAstat-Dx SARS-CoV-2 test kits currently available in the United States are the first syndromic tests, which can detect SARS-CoV-2 as well as more than 20 other respiratory targets. The company is also on track to ramp up its test kit production to help contain the coronavirus outbreak.

Additionally, QIAGEN is currently supplying RNA extraction kits to the United States and other countries to accelerate the efforts to contain the outbreak.


With the efforts, QIAGEN aims to strengthen its foothold in the global Molecular Diagnostics market.

Background Prior to the Release of the Test Kits

The release of the test kits was preceded by the announcement of QIAGEN receiving funding for the project in part from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority Division of Research, Innovation, and Ventures.

Significance of the Release

The QIAstat-Dx SARS-CoV-2 test kits, which QIAGEN has already started shipping to other countries from February for clinical validation, runs on the company’s Sample to Insight syndromic system. The syndromic system automates molecular analysis to deliver differential diagnosis in about an hour. The automation system enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows, thus speeding up the result delivery.

Additionally, the panel detects a few other pathogens and subtypes of respiratory infections like Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63 and Coronavirus OC43. However, given the current increasing testing demand, the regulatory status of the QIAstat-Dx Respiratory SARS-CoV-2 Panel will vary by location.

Industry Prospects

Per a report by Grand View Research, the global IVD market size was valued at $60.8 billion in 2019, and is expected to witness a CAGR of 4.4% between 2020 and 2027. Factors like growth in the prevalence of chronic and infectious diseases, increasing adoption of fully automated instruments, and automation in laboratories are expected to drive the market.

Given the global condition of the market amid the COVID-19 outbreak, QIAGEN seems to have huge market potential.



Recent Developments in Molecular Diagnostics

Of late, QIAGEN has been working toward combatting the COVID-19 outbreak.

The company is currently ramping up production of test kits for the detection of SARS-CoV-2 in patients. In March, it received the CE mark for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test for the detection of SARS-CoV-2. The product is now available for use by the clinical laboratories in Europe. Further, QIAGEN obtained derogation in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte for the test.

In February, the company announced that it is currently providing various testing solutions for SARS-CoV-2 like enabling laboratory-developed tests, mid- and high-throughput automation, and two new real-time polymerase chain reaction (“RT-PCR”) tests for the detection of SARS-CoV-2. However, the RT-PCR tests (developed at QIAGEN sites in China and the United States) will be available for research purposes only.

Price Performance

Shares of QIAGEN have gained 0.1% in the past year against the industry’s 15.7% decline.

Zacks Rank & Other Key Picks

Currently, the company carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are ResMed Inc. (NYSE:RMD) , Medtronic plc (NYSE:MDT) and Hill-Rom Holdings, Inc. (NYSE:HRC) .

ResMed has a projected long-term earnings growth rate of 14.4%. It currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is estimated at 7.1%. The company presently has a Zacks Rank #2.

Hill-Rom’s long-term earnings growth rate is estimated at 11.1%. It currently carries a Zacks Rank #2.

Just Released: Zacks’ 7 Best Stocks for Today

Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.5% per year.

These 7 were selected because of their superior potential for immediate breakout.

See these time-sensitive tickers now >>



Medtronic PLC (MDT): Free Stock Analysis Report

ResMed Inc. (RMD): Free Stock Analysis Report

QIAGEN N.V. (QGEN): Free Stock Analysis Report

Hill-Rom Holdings, Inc. (HRC): Free Stock Analysis Report

Original post

Zacks Investment Research
QIAGEN Releases Coronavirus Test Kit In US On New FDA Policy
 

Related Articles

Daniel Shvartsman
A Bear Market Shopping List By Daniel Shvartsman - Jun 25, 2022 21

Volatility has been the constant in the 2022 bear market. Wherever we go in the next 12-18 months, bargains are starting to emerge. Here are five stocks I think are positioned well...

Brett Owens
Almost 13% Yield Monthly? Come On By Brett Owens - Jun 24, 2022

Patience is the key to being a successful contrarian investor. We buy when fear is widespread. Bear markets are our friends. Let’s sit back and let the market’s...

QIAGEN Releases Coronavirus Test Kit In US On New FDA Policy

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
or
Sign up with Email