Volume XIV
January 2020 - Top Stories:

Coronavirus in China cities could trigger global epidemic.
Experts from Hong Kong said sustained novel coronavirus (2019-nCoV) transmission is under way in China's largest cities, putting the world on the verge of a global epidemic, as China's official outbreak total climbed to nearly 3,000.

Liquid Biopsy is positioned to change the way that healthcare is conducted and it will give lab an opportunity to have a great impact on the early detection of cancer .
The life-saving implications of these discoveries are mind-blowing! Watch our Petri Dish Webinar as we highlighted four new liquid biopsy lab tests that are hitting the market and find out how you can get in the game:
WHAT'S TRENDING?
The U.S. Food and Drug Administration (FDA) has announced critical actions to advance development of novel CORONAVIRUS medical countermeasures.
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We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. 
As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.

As part of FDA’s ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests.


INDUSTRY INSIGHTS
Best Advice on How to Commercialize a Laboratory Test:

Eureka! Your Research and Development team has found a new biomarker or made some life science-related discovery. Now what? Assuming that you want to make your new finding available to the world, while also monetizing it in some way, there are a few paths forward.

We want to highlight in here one of the three paths that is much less frequently used and has some important advantages. This third path takes less time and resources and could enable you to generate revenue as quickly as three months instead of three years. 

If your discovery is classified as a laboratory test it needs to be performed in a CLIA-accredited medical laboratory that falls under the authority of the U.S. Department of Health and Human Services. So far, this probably doesn’t sound like good news, but there is a silver lining. While laboratory tests do need to be approved by the FDA, under certain circumstances it is not required if you decide to validate the test as a laboratory-developed test (LDT). Keep reading a full article HERE.


Many lab owners are looking at ways to diversify their offerings.

We are happy to offer a new program to recruit and administer your specimen collector/phlebotomist network. As you know, keeping track of your specimen collection team hours, credentials and compliance can easily be a full-time job. If your current program is causing headaches, Lighthouse is here to provide a solution. Review a PDF HERE.

In addition to helping you find necessary technical staff, Lighthouse Lab Services can also provide recommendations on test menus, equipment, software and everything else needed to add CGX/PGX and Infectious Disease testing. Want to know more?

Having a director for your high-complexity CLIA lab is a requirement, but did you know that a part-time lab director could be an appropriate option and significantly shrink your overhead costs?

What is the difference between a part-time and full-time lab director?
One of the most common questions when hiring a part-time lab director concerns whether or not there is a difference in services rendered. Tara Luellen, MA, our National Account Manager for part-time lab directors, explains that “If a lab is paying much less for director services, certainly the director cannot be expected to complete 40 hours’ worth of work that would be completed by a full-time director.” That being said, a lab director, whether part-time or full-time, has a set of responsibilities as defined by CLIA in 42 CFR 493.1445. See a full list of duties here.


How exactly does a part-time lab director shrink a lab’s overhead cost?
A full-time lab director commands a salary of around $150,000+ annually, while a part-time lab director generally makes between $12,000-$24,000 annually. By employing a part-time lab director instead of a full-time lab director, a lab can save well over $100,000 per year!

You might have another questions, like: When is it acceptable to hire a part-time lab director instead of a full-time lab director? If a director only works part-time, how can he/she complete all of the lab director duties? Why would a lab director choose to only work part-time for less pay? Read our full article to find answers to those questions.

Contact our Lab Director Program Manager to learn more and/or receive a quote for Lab Director Services specific to your facility so that your lab is always inspection-ready and compliant.
Buyer + Seller Services
In 2019, Lighthouse Lab Services sold 19 laboratories!

If you are interested in hearing more about our seller services, or if your group is actively seeking to acquire a laboratory, please reach out to schedule an initial consultation.  Visit our website and reach out to arrange a call if you're interested in our Buyer + Seller Services.

The Lab Insighter is a quarterly publication for Lab Owners and Decision Makers.
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