D1 PD.pdf

Purchase Description

Name of Item or Project Title:

Purchase of Maestro Pro 768 channel MEA system with Cardiac, Neuro, and Impedance modules, with installation, training, and 12 months warranty (brand-name or equal). This is a

COVID-19 related activity.

Statement of Need and Purpose:

The purpose of this requisition is to procure a Maestro Pro 768 channel MEA system with

Cardiac, Neuro, and Impedance modules, with installation, training and 12 months warranty

(brand-name or equal) for the Therapeutic Development Branch (TBD) within the National

Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI).

The Maestro Pro system will allow TBD scientist to perform compound and drug toxicity screening on cells by measuring changes in electrical activity and impedance with this system.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Division of Preclinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum. Specifically, this division:

• Plans, conducts and collaborates on research to develop new methods and technologies to enhance preclinical processes.

• Plans, conducts and collaborates on research to evaluate existing and developing approaches, technologies, and processes in the preclinical spectrum.

• Supports training programs relevant to preclinical phases of translational science.

• Allocates DPI resources to preclinical extramural and intramural investigators.

• Collaborates with other NIH Institutes and Centers and the scientists they support.

• Consults with stakeholders, including patients, industry and regulators.

The Antiviral Program for Pandemics (APP) aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential.

The APP is developing assays for predicative toxicity of antisense oligonucleotides (ASOs), which will be used as the next generation of antivirals as well as treatments for rare diseases.

A major bottleneck in the development of ASO therapies is unanticipated off target neurological or cardiac side effects that prevent such treatments from passing clinical trials. In order for antiviral ASOs to be quickly developed against COVID-19 and to fight future pandemics, it is essential to be able to predict ASO toxicity as early as possible in the process. Predictive toxicity will be assessed using Microelectrode Arrays (MEAs) in an automated system to streamline this assay for high throughput screening of COVID-19 ASOs and other antiviral

ASOs.

MEAs are devices composed of a grid of planar metal microelectrodes distributed across a small surface for recording electrical signals from neuronal or cardiac networks. Primary neuronal cultures or cell lines seeded directly onto MEAs plates allows measurement of extracellular voltage changes as cells generate action potentials. Recently, the use of MEAs for toxic screening assays has gained traction as they measure alterations in neuronal network signaling and allows for testing of both acute and chronic exposure to screening compounds.

Thus, the Therapeutic Development Branch (TBD) within the National Center for Advancing

Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) requires the Maestro

Pro System (brand-name or equal) in order to meet the needs of the Antiviral Program for

Pandemics Project.

Moreover, the Maestro Pro 768 channel MEA system with Cardiac, Neuro, and Impedance modules, (brand-name or equal) will be used in conjunction with the automated Maestro APEX system and is essential for the workflow required for the project. The Maestro APEX’s integrated incubator has a maximum capacity of 44 MEA plates, allowing this automated MEA system to be used in a high throughput workflow. However, the onboard Maestro MEA recorder will not be able to independently handle such a heavy work volume of MEA recordings and an external MEA system must be used in conjunction for this project. The use of the Maestro Pro

768 channel MEA system with Cardiac, Neuro, and Impedance modules, (brand-name or equal) compatible with the Maestro APEX system is essential as it also has the capability of measuring impedance, allowing the real time, label free tracking of cell proliferation, morphology, and viability

Generic Name of Product:

Multiwell Microelectrode Array (MEA) system with installation, training, and warranty.

Purchase Description:

For reference purposes, the Multiwell Microelectrode Array (MEA) system that meets the need of this requirement is the Maestro Pro 768 channel MEA system with Cardiac, Neuro, and

Impedance modules, as follows:

Item Number Part Number QTY Description

1 MAESTRO768PRO 1 Maestro Pro 768 channel MEA system with BioCore v4

2 CARDIO-PRO 1 Cardiac Applications Module

3 NEURO-PRO 1 Neuro Applications Module

4 IMP-PRO 1 Impedance Applications Module

5 INT-OS 1 Installation and Training (two-day training)

6 Shipping 1 Shipping and Handling FOB destination

The salient characteristics of the brand-name or equal Multiwell Microelectrode Array

(MEA) system shall include:

• Ability to measure impedance, allowing the real time, label free tracking of cell proliferation, morphology, and viability;

• Compatible with Maestro APEX system;

• 768-channel MEA system that can accommodate 12, 48, and 96-well Axion MEA plates;

• Temperature control and CO2 delivery capabilities;

• Desktop computer and monitor with Windows 8 or higher operating system;

• AxIS software for data acquisition and analysis;

• Ability to measure cardiac activity parameters such as beat timing and pacing, arrhythmias, depolarization, and action potential propagation;

• Ability to measure neuronal network functions such as general activity, synchrony, and network oscillations;

• Ability to measure impedance to allow tracking of cell proliferation, morphology, and viability;

• 1 year warranty

• Handling and Shipping, FOB Destination.

Quantity:

One Multiwell Microelectrode Array (MEA) system with installation, training, and warranty.

Delivery Date:

Delivery is required within 30 days after award (ARO). Delivery shall be made to the below address with FOB Destination.

National Center for Advancing Translational Sciences (NCATS)

9800 Medical Center Drive

Rockville, MD 20850

The two-day installation and training shall be conducted on dates and times agreed upon by the vendor and the NCATS point of contact designated on the award.