COVID-19

Yes. The current CDC Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 states that routine diagnostic testing of specimens can be handled in a biosafety level 2 (BSL-2) laboratory using Standard Precautions. Metabolon has an existing BSL-2 certification for all biofluids, including human plasma, serum, and urine. We have strict restrictions for accepting BSL-2 contaminated biosolids, specifically for fecal samples. Please refer to General Question 3 below for guidance or contact us for more information.

Yes. Due to the urgency and importance of COVID-19 research, we are offering expedited turnaround times of COVID-19 projects. Data only projects can be delivered in 2-4 weeks from date of sample receipt and full interpretation projects can be delivered 4-6 weeks from sample receipt. In addition to providing priority scheduling of sample processing on our global metabolomics platform, we have also a dedicated team of experienced study directors to address client questions, lead study design and draft final biological interpretation reports.

The CDC provides full details for biosafety levels online at: https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.pdf

The COVID-19 situation has presented everyone with a temporary new normal. We are adjusting accordingly and monitoring the changing situation daily, adjusting our business operations to ensure you continue to receive the highest quality service without disruption while keeping our employees safe. We will continue to keep our clients and stakeholders apprised of operational changes as the situation evolves.

• We have been closely monitoring guidance from the World Health Organization and local authorities throughout our business footprint. The recommendations have led us to activate our robust Business Continuity Plan with specific steps to account for COVID-19. We are focused on both protecting the health and welfare of our employees and implementing updated business procedures to ensure we continue providing on-time delivery of your projects.
• We have asked our desk-based employees to work from home as a precaution, supporting guidance from the World Health Organization and Centers for Disease Control that encourage social distancing.
• For our lab-based employees, we are implementing shift work schedules to reduce the number of people in one place at one time and continuing to maintain stringent handwashing and cleaning practices. These measures will both ensure the safety of our staff and the on-time delivery of your project.

• Metabolon is and has always been committed to the health and safety of our employees and our community. As such, all samples are treated in accordance with strict lab safety protocols including the use of proper personal protective equipment (PPE), proper biohazardous waste handling practices, and extensive environmental controls including bio safety cabinets.
• Metabolon is capable of handling biofluid samples up to a BSL2 level.
• Metabolon is capable of handling human fecal samples and non-human fecal samples contaminated with a BSL2/class 2 biological agent as long as those samples have been dried in a lyophilizer and shipped to us as freeze-dried material.
• Metabolon can accept other, non-fecal, biosolid types contaminated with BSL2/Class 2 agents as our protocols for these steps maintains safety requirements with either methanol soak or other similar processes. For accepting cell pellets, we require customers to provide an accurate cell count for normalization purposes.

We are currently working on a new protocol to accept “wet” (flash frozen) human and non-human fecal samples that will allow us to receive these samples without being dried in a lyophilizer prior to shipment. More information will be available soon.

We are continuing to receive samples per normal operations. Dedicated staff will be onsite at our RTP site each day to meet global couriers such as World Courier, UPS and FedEx.

• Please send your samples by your previously agreed upon delivery date or sooner, if possible.
• We are continuing to receive samples per normal business operations and will have someone onsite each day to meet our global couriers such as World Courier, UPS and FedEx.
• Once you ship your samples, please provide your client success manager and SampleManager@metabolon.com a tracking number so we can be sure to know when to expect the delivery.

• While we have made some adjustments to our business practices in light of COVID-19, we continue to operate at full capacity and do not anticipate any major delays in our ability to deliver your project on time. If we encounter any challenges, we will notify you immediately.
• Please do not hesitate to contact your sales representative or client success manager if you have questions about your project timetable.

• While Metabolon has implemented business continuity practices that allow staff to work remotely or in shifts to enable social distancing, our Client Success project managers and Study Directors continue to be available to you during regular office hours.
• As per standard practice, please continue to reach out to your regular Client Success and Study Director contacts once you have shipped samples.

• While Metabolon has implemented business continuity practices that allow for staff to work remotely or in shifts to enable social distancing, we continue to operate at full capacity.
• We do not anticipate any major delays in project delivery, but if we encounter any challenges, we will notify you immediately.

We will return samples as per our current agreements with each client provided no employees at our RTP headquarters have tested positive for COVID-19 or exhibited symptoms requiring COVID-19 testing.

If you determine that your study submitted samples from any patient exposed to COVID-19, please notify us immediately. We will notify the North Carolina Department of Health and Human Services and take appropriate action based on their guidance.

We continue to be able to receive biological samples from all international locations. Please consult your chosen courier’s website for any local logistics updates that may impact your individual shipments:

• World Courier
• FedEx
• UPS