part 2Founded in 2010 by CEO Bruce Patterson, IncellDx has developed a two-step platform that performs single-cell molecular analysis without losing the intact cell. The company aimed to build a pre-analytical product package and analytical workflow that could accommodate any sample type.
The firm's sample prep technology uses a non-enzymatic approach for preparing single-cell suspensions from a patient's tumor. A technician starts by using a tissue punch to remove a portion of the tumor and then adds 800 ml of phosphate buffer saline to the sample. A small, non-shearing motor is added to the cuvette, and the device slowly homogenizes the tissue, releasing cells that can be analyzed in a single-cell detection system.
"We made it amenable for 20- to 30-color analysis, instead of using an embedded tumor tissue that, in the clinical sense, is less useful," Patterson said. The firm's single-use, micro-homogenizer, called IncellPrep, produces a usable sample within 5 to 10 minutes.
After sample prep, the second part of the workflow, called "simultaneous ultrasensitive signal- amplification hybridization in situ" (SUSHI), quantifies multiple proteins and molecular biomarkers inside the patient's isolated cells.
"The hallmark of the technology is to be able to prepare the cell for molecular biology without destroying it, yet in a way that it would be agnostic to the platform, whether using flow cytometry, imaging, and lately, CTCs," Patterson explained. IncellDx now offers a suite of library prep and diagnostic products using the two-step method for a variety of cancers, including bladder, lung, and breast cancer.
For example, the firm's HPV OncoTect 3Dx assay simultaneously detects and quantifies three molecular markers of cervical cancer: oncogene overexpression (E6/E7 mRNA), proliferation, and aneuploids in intact cells. The flow cytometry-based test analyzes 96 liquid-based Pap samples in less than four hours and helps clinicians identify which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia.
Factorial Dx plans
As part of their agreement, IncellDx will offer Factorial Dx its IncellMax-Seq reagent to engage in in situ library preparation for next-generation sequencing (NGS) applications. The reagent, which keeps the sample stable up to two weeks, maximizes different parameters such as cell yield and recovery before target cells are lysed and sequenced.
Patterson noted that Factorial Dx has unique library prep elements that complement IncellDx's approach. IncellDx also seeks to establish a presence in the sequencing space by developing a novel library prep workflow while keeping the platform affordable for customers.
IncellDx's ultimate goal for the project with Factorial Dx is to develop library prep kits that customers can run on their own sequencing instruments.
Patterson argued that traditional bulk, NGS cancer diagnostics can miss important phenotypic data during standard library prep, which typically involves grinding up the cells for their genomic components.
The firm's sample prep technology uses a non-enzymatic approach for preparing single-cell suspensions from a patient's tumor. A technician starts by using a tissue punch to remove a portion of the tumor and then adds 800 ml of phosphate buffer saline to the sample. A small, non-shearing motor is added to the cuvette, and the device slowly homogenizes the tissue, releasing cells that can be analyzed in a single-cell detection system.
"We made it amenable for 20- to 30-color analysis, instead of using an embedded tumor tissue that, in the clinical sense, is less useful," Patterson said. The firm's single-use, micro-homogenizer, called IncellPrep, produces a usable sample within 5 to 10 minutes.
After sample prep, the second part of the workflow, called "simultaneous ultrasensitive signal- amplification hybridization in situ" (SUSHI), quantifies multiple proteins and molecular biomarkers inside the patient's isolated cells.
"The hallmark of the technology is to be able to prepare the cell for molecular biology without destroying it, yet in a way that it would be agnostic to the platform, whether using flow cytometry, imaging, and lately, CTCs," Patterson explained. IncellDx now offers a suite of library prep and diagnostic products using the two-step method for a variety of cancers, including bladder, lung, and breast cancer.
For example, the firm's HPV OncoTect 3Dx assay simultaneously detects and quantifies three molecular markers of cervical cancer: oncogene overexpression (E6/E7 mRNA), proliferation, and aneuploids in intact cells. The flow cytometry-based test analyzes 96 liquid-based Pap samples in less than four hours and helps clinicians identify which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia.
Factorial Dx plans
As part of their agreement, IncellDx will offer Factorial Dx its IncellMax-Seq reagent to engage in in situ library preparation for next-generation sequencing (NGS) applications. The reagent, which keeps the sample stable up to two weeks, maximizes different parameters such as cell yield and recovery before target cells are lysed and sequenced.
Patterson noted that Factorial Dx has unique library prep elements that complement IncellDx's approach. IncellDx also seeks to establish a presence in the sequencing space by developing a novel library prep workflow while keeping the platform affordable for customers.
IncellDx's ultimate goal for the project with Factorial Dx is to develop library prep kits that customers can run on their own sequencing instruments.
Patterson argued that traditional bulk, NGS cancer diagnostics can miss important phenotypic data during standard library prep, which typically involves grinding up the cells for their genomic components.
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