In Vitro Skin Toxicity Testing

The majority of studies performed by HemoGenix® incorporate a Complete Service, Full Report that can be used for an IND application. More recently, Sponsors have requested a more streamlined study and studies involving high-throughput screening. For this reason, HemoGenix® now provides 3 types of study format. 

1. Complete Service, Full Report Study: Fully customized study that includes the Study Plan, Draft Text and Final Text Report with QA audit.
2. Rapid Toxicity Study: A customized study that includes the Study Plan and full protocol, raw results and graphical data in a single Excel Workbook. No formal text report and no QA audit is performed. This type of study is designed for early drug development. No interpretation or conclusions are provided.
3. High-Throughput Screening Study (presently only available for human studies): A screening study is designed for high-throughput screening of compounds during ADME/Tox screening in multiples of 5 on specific cell populations to provide the most important ranking information. The full protocol, raw results and graphical data are provided in an Excel Workbook. No interpretation or conclusions are provided. This type of Screening Study is part of the ComparaTOX™ HT Platform.

With the introduction of standardized and validated ATP bioluminescence in vitro toxicity assays starting with HALO®-Tox HT for bone marrow toxicity/stem cell hematotoxicity testing in 2002, HemoGenix® has developed a number of in vitro toxicity testing assay platforms. One of the latest additions to the HemoGenix® in vitro toxicity testing family is SkinGlo™-Tox HT. This joins other ATP bioluminescence - based toxicity testing assays that can be performed in parallel with each other, since they all use a common readout. This extended toxicity testing platform is called the ComparaTox™ Platform.

• Many primary skin cell populations exhibit proliferation that correlates with the intracellular ATP concentration measured using SkinGlo™-Tox HT .
• SkinGlo™Tox HT can be used for skin cells from various species..
• SkinGlo™-Tox HT incorporates a validated ATP bioluminescence readout to measure potential skin toxicity.
• SkinGlo™-Tox HT is a calibrated and standardized assay platform that allows results to be directly compared between different drugs, as well as different cell types over time.
• SkinGlo™-Tox HT is a high-throughput assay platform using 96- or 384-well plate formats allowing ADME-Tox drug or compound screening, thereby significantly reducing unexpected results during pre-clinical testing.
• SkinGlo™-Tox HT can be used to investigate cellular drug-drug interactions or multiplexed with assay readouts.
• Incorporates the most sensitive ATP bioluminescence readout available.
• Study Turnaround time: Usually within 4-5 days.
• Validated assay readout according to FDA Bioanalytical Method Guidelines.
• Supports the 3Rs (Reduction, Refinement, Replacement) assay platform for animal testing.

• Fresh or cryopreserved cells
• Dermal fibroblasts
• Microvascular endothelial cells
• Dermal and epidermal cell lines 

SkinGlo™-Tox HT can be used with proliferating skin cells from a variety of animal species.

Please contact HemoGenix® for more information.

• Membrane integrity: LDH or PI dye exclusion
• Apoptosis: Biochemical caspase detection
• Mitochondrial dysfunction: Mitochondrial ToxGlo™
• Glutathione Assay (GSH): Oxidative stress
• OxyFLOW™: Oxidative DNA damage

Please also view the Mechanism of Action page.

When compounds are tested for potential toxicity using assays that employ different signal detection systems, the results cannot be compared directly. The unique in vitro toxicity testing platform called ComparaTOX™ allows cell types from different organs and tissues to be directly compared with other. ComparaTOX™ is based on the fact that all HemoGenix® toxicity assays use a common readout, namely a standardized and validated ATP bioluminescence signal detection system. This allows the response to drugs and other agents to be ranked according to:

1. Drug toxicity
2. Cell type
3. Species

You can perform in vitro intestinal toxicity testing in-house using assay kits sold by Preferred Cell Systems™. Please click on the links below to take you to the assay kit page on the Preferred Cell Systems website. 

• SkinGlo™-Tox HT