Updated Statement from Kallaco

By August 26, 2020August 28th, 2020News

August 26, 2020

As a response to inquiries, please find below a list of key statements along with a more robust Q&A pertaining to Kallaco and its partner laboratories.

We understand the uncertainty and concerns that COVID-19 has caused in so many communities. Kallaco was intentionally founded to alleviate stresses of this pandemic by providing technology solutions associated with trustworthy diagnostic data. We are steadfast in our mission and stand by our approach thus far.


Key Statements

  • Kallaco is a new company formed by individuals and partners with deep experience in healthcare investment and innovation. Biographies of team members are listed in the Q&A section below.
  • Kallaco is a logistics and software company, not a laboratory. We offer solutions for monitoring employee and student health with a variety of software tools.
  • In addition to our software tools, Kallaco works with high-complexity, CLIA-certified and CAP inspected laboratories who can provide testing options for clients. The federally regulated Clinical Laboratory Improvement Amendments (CLIA) program provides oversight and certification at the highest level in the U.S.
  • Kallaco only partners with high-complexity CLIA laboratories. High-complexity CLIA laboratories, through the Laboratory Developed Test (LDT) process, do not need FDA approval to administer COVID-19 tests, including self-collection.


Q&A

What’s the difference between Kallaco and Opteo Laboratory?
Kallaco is a logistics company that links CLIA-certified laboratories with people and organizations that need testing at scale. Opteo Laboratory, one of Kallaco’s laboratory partners, is a CLIA-certified laboratory that has provided the testing for all Virginia schools to date.


Is the test used by Kallaco’s laboratory partners EUA-approved by the FDA for self-collection?
The self-collection system used by our university clients is allowed by CLIA (the governing body of all U.S. laboratories), through the Laboratory Developed Test (LDT) process, and by the FDA under Emergency Use Authorization (EAU).

As a high-complexity, CLIA-certified laboratory using their own LDT, Opteo Laboratory is allowed to conduct analysis of both self-collected and healthcare professional  collected samples.  Like many other clinical laboratories in the US, Opteo has submitted an EUA to the FDA for both collection processes which is currently under review.

There are over 100 laboratories across the United States, just like Opteo Laboratory, with pending EUA applications with the FDA.


What does it mean to be a CLIA-Certified laboratory and why don’t they need FDA approval to run COVID-19 tests?
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. For laboratories to receive CLIA certification from CMS they must submit a comprehensive application, provide certification of qualified licensed professionals who will work in the laboratory, and undergo a comprehensive inspection process that evaluates the laboratory’s policies, workflows, procedures, quality programs, and validation studies on the particular tests they provide.

High-complexity, CLIA-certified laboratories are not required to seek FDA approval on Laboratory Developed Tests (LDTs) that they design and use in their laboratory. On August 21, 2020 it was announced that the FDA no longer had authority over lab-developed tests, including requirements that certain diagnostics made for COVID-19 go through the agency’s emergency review and authorization process.


Are the self-collected, home test kits used by Kallaco’s laboratory partners reliable and are the results from these tests accurate?
Kallaco’s laboratory partners are required to conduct extensive validation studies, proficiency testing, and have their specimen accuracy evaluated by other peer laboratories as part of their testing process.  Opteo Laboratory (one of Kallaco’s partner laboratories) performed validation studies as part of their LDT and was able to reproduce the same performance characteristics as the ThermoFisher Scientific TaqPath COVID-19 Combo Kit which had a 100% sensitivity rate and a 100% specificity rate.

In addition, all samples are analyzed at CLIA certified laboratories.  Each sample is reviewed and validated by certified laboratory/medical professionals.  Only samples that have sufficient specimen material are run at the laboratory.  If there is insufficient material, or if the specimen has been damaged in any way, a new sample is collected.

 

Why does the test vial have a sticker that reads “for research use only”?
It is common when you create an LDT that there are going to be components that are used for diagnostic purposes and some that are not. The vial is not used for diagnostic purposes so it is labeled “for research use only”.  We are not required to put the label on the vial,, but we want to be as transparent as possible with respect to the use of our test kit components.


If the Kallaco laboratories use the ThermoFisher Scientific TaqPath COVID-19 Combo Kit does that mean they may have false results?
Although there have been some reports of false test results due to the processing of samples, Kallaco’s partner laboratories have established procedures that mitigate against processing errors and they do not use the same process or software that has been questioned by the FDA.

 

Why does Kallaco collect personal health data and how do they keep it secure?
Kallaco collects the minimum amount of personal health information (PHI) in order to provide essential health data to our clients and any performing laboratory, if testing is involved. Kallaco, along with any other entity who receives PHI, is bound by strict data privacy and HIPAA laws when it comes to using and storing such data. For additional details about Kallaco’s privacy policies please click here: https://kalla.co/privacy-policy/.


Kallaco is such a new company. Who are they?
Kallaco was created by U.S. healthcare executives who saw firsthand the need for a comprehensive technology platform that could also include integrated diagnostic testing.  This vision was cemented as the COVID-19 pandemic hit Kallaco’s hometown of New Orleans, LA.  The CEO, John Spivey, has extensive experience in both healthcare technology and laboratory operations and set about building a company that could bring a needed solution to businesses and universities as they made plans to return to work and campus.


Who runs Kallaco?
The Kallaco leadership team has worked in healthcare for decades, supporting universities, hospitals, and employers in many different capacities. Our leadership team is comprised of:

John M. Spivey, Founder / CEO
John is the founder and CEO of Kallaco which is based in New Orleans, Louisiana. He has over 25 years of experience in executive leadership and entrepreneurial ventures in multiple technology and healthcare endeavors. John formed his first start-up, Vention, Inc., at age 25, which grew into one of the largest e-business application development firms in the southeast. John was later instrumental in founding a number of healthcare ventures including: Bladder Health Network, Sigma Health Ventures, EngageDX, Constance Ventures, and Availiant Healthcare Strategies which provides management and consulting services to clinical laboratories. John received his Bachelor’s and Master’s degrees from the University of Mississippi and completed his doctoral coursework at the University of Kansas.  

James McMahon, CFO
James is an executive with more than 13 years of experience in corporate finance, mergers & acquisitions and general business operations. He has spent the past six years in the healthcare industry, first in the corporate strategy department at Blue Cross Blue Shield of Louisiana and then helping to develop several healthcare ventures, most recently Kallaco, where he serves as the CFO. Prior to working in health care, he spent seven years working in various corporate finance and private equity roles in the energy industry including: director of mergers & acquisitions and director of financial planning & analysis for two global fortune 500 companies. James holds an MBA from Tulane University and a Bachelor’s of Science in Management from The University of New Orleans. He also spent twelve years serving in the U.S Military, completing multiple overseas deployments.

Dr. San San Ng, Chief Scientific Advisor
San San Ng has her Ph.D. in Molecular Biology & Human Genetics and has her CLS-S and ASCP Board certifications. She has spent her entire career in advanced genetics research and applying state-of-the-art laboratory science to aid in the health and care of patients. She is an avid supporter of personalized health, with over 20+ years of experience working in multiple disciplines, including clinical pathology, biochemistry, molecular biology, human genetics and cancer. Dr. Ng serves as the Chief Scientific Advisor to Kallaco. She completed her Bachelor’s degree in Cell and Molecular Biology at Tulane University in New Orleans. She then completed her Ph.D. in Human Genetics at Louisiana State University Health Sciences Center.

James Perkins, EVP Product, Client Engagement
James has spent the last nine years in Healthcare Informatics developing, deploying and integrating software applications for large hospital systems and healthcare startups. Working with systems like West Jefferson Medical Center and LCMC Health, James helped implement EMR cutovers and PACS migrations. Working for startups like EngageDX and most recently Kallaco, James focuses on developing strategies for product development and system integration, as well as building teams focused on client success and engagement. James holds a Bachelor’s of Science in Management from Southeastern Louisiana University and a Bachelor’s of Science in Nursing from William Carey University. Before moving to Information Technology, James spent several years working as a Registered Nurse in the greater New Orleans area.


Why is Kallaco the best option for these universities?
Kallaco’s technology enabled platform has the ability to turn around relatively large numbers of tests through their network of CLIA certified laboratories in less than 72 hours. This is possible because Kallaco’s clients have specific, measurable testing needs that can be planned in advance with laboratory partners.  Unlike national testing labs who have unknown volumes that arrive daily, Kallaco laboratory partners are given advance testing cadences to be able to prepare for and manage the testing in a fast and efficient manner.


How has Kallaco quickly acquired such a large number of tests? How many tests have they completed?
Currently, Kallaco partners with three laboratories and is in talks to create relationships with additional labs in the near future. To date, Kallaco’ laboratory partners have delivered testing to over 20,000 individuals.


Which lab does the bulk of the testing?
Much of the Virginia university testing to date has been in concert with Kallaco’s partners at Opeto Labs, which is a high complexity CLIA laboratory.


Is Kallaco’s testing FDA approved?
The testing provided by Kallaco has all of the licenses required in the U.S. As an extra step, the testing was submitted to the FDA and the Kallaco labs have the authority to run the test under FDA EUA guidelines.


Is Kallaco experiencing delays in testing?
No process is ever perfect, but we are proud to say that the average turnaround time has been 44 hours.

In the coming days we will be posting more answers to questions as we receive them on our site. We are committed to being as transparent as possible while providing the safest tests and technologies available.

Have more questions for us?
In the coming days we will be posting more answers to questions as we receive them on our site. We are committed to being as transparent as possible while providing the safest tests and technologies available. We understand that these are very challenging times. There are a lot of questions and everyone deserves full transparency. Here is a list of commonly asked questions. You can also reach us at connect@kalla.co.