ICE-COLD PCR™ Targeted Enrichment Kit is suitable for Sanger sequencing platforms.

Press Release Summary:

ICE-COLD PCR™ Targeted Enrichment Kit is used to identify resistance mutations in non-smell cell lung cancer. Unit can detect genetic mutations in liquid biopsies such as blood samples.

Original Press Release:

Precipio Launches Its Second New ICE-COLD PCR™ Targeted Enrichment Kit To Identify Mutations in Lung Cancer Using Liquid (Blood) Biopsies On Sanger Sequencing Platforms

Precipio, Inc. (NASDAQ:PRPO), announced today the launch of the second new version of its ICE-COLD PCR™ (ICP) enrichment kit, used to identify resistance mutations in non-small cell lung cancer (NSCLC) using liquid biopsies. As part of the transformation of ICP to be platform-agnostic, this kit has been adapted to be used on Sanger Sequencing platforms, a widely used DNA sequencing method in molecular diagnostics. Precipio's newly designed multiplexed kit enables laboratories using Sanger Sequencing platforms to now adopt the ultra-sensitive, low cost solution that ICP offers.

"Sanger Sequencing is one of the most prevalent and commonly used platforms for molecular diagnostics. In use for 40 years, it is reliable, easy to use, and very economical to run,” said Jeffrey Sklar, MD, PhD, Chairman of Precipio's Scientific Advisory Board. “This kit expands the reach of ICP to laboratories using Sanger Sequencing, giving physicians access to important testing capabilities for ongoing diagnoses and continued monitoring of their patients," Dr. Sklar added.

Precipio's multiplexed ICP kit offers major improvements to current sequencing technologies and platforms, primarily the ability to detect genetic mutations in liquid biopsies such as blood samples. ICP delivers a 100 – 500-fold increase in mutation detection sensitivity (depending on the platform used) compared to current methodologies. Precipio's new kit, offered at a fraction of the cost of competing assays, provides the only economically-viable product on the market enabling laboratories to conduct repeat testing to consistently monitor patients. Hospitals that already conduct such genetic testing on solid tumor biopsies can implement ICP in several days and substantially expand the test menu they offer, alongside increasing their revenue and profitability.

"As promised, our R&D team continues to execute on our plan and deliver our growing product pipeline, on schedule. The launch of our second ICP kit for Sanger, follows the release of our first kit for qPCR platforms, and demonstrates the continued work to create a robust, platform-agnostic offering," said Ilan Danieli, President and Chief Executive Officer of Precipio. "The product we launched today again fulfils our promise to bring to market a comprehensive new line of products that provide solutions to a diverse set of customers, including hospitals, reference laboratories, CROs and others, delivering the promise of liquid biopsy to benefit as many patients as possible," Mr. Danieli continued.

This new product continues the expansion of the market potential for ICP by providing additional revenue-generating products for hospitals. When a cancer patient undergoes treatment at a hospital, testing is required for either initial diagnosis, or continued monitoring of disease progression and the patient’s ongoing response to treatments. Currently, there are limited testing options for hospitals to monitor their patients, which typically involve outsourcing testing to a specialty diagnostic laboratory. Sending these tests to outside laboratories means losing control of the samples; no access to data being generated from these tests; and loss of revenue. ICP gives hospitals the ability to conduct these tests in-house, without having to rely on outside specialty labs. For a hospital laboratory with the existing ability to perform Sanger Sequencing, this represents high-margin, add-on revenue with very little cost, since the hospital already has the equipment and the personnel required to perform these tests.

All ICP kits are designed to target actionable genes and mutations only with associated billable codes, therefore hospitals performing these tests, can, in fact, bill and generate revenue rather than incurring the cost of sending it to an outside laboratory.

The new kit using ICE-COLD PCR™ averages a cost per test of approximately $150; hospital revenue per test is approximately $600, creating a profitable service model for hospital laboratories with generous profit margins. As an example, a 500-bed hospital that would care for an estimated 200 lung cancer patients annually, who can be monitored every 3-6 months, would run an estimated 400-800 tests per year, generating revenues of $250,000-$500,000 per year from this one test kit.

As Precipio continues to develop and release new kits for different cancer types (colon, breast, melanoma, etc.), hospitals that are already set up with ICP technology can easily onboard additional kits for other types of cancer. This enables the hospital to generate revenues exceeding $1M across various types of cancer, while maintaining full control over the specimen, service and the data being generated. By the end of 2018, Precipio plans to have a total of 5-7 cancer-specific kits available for hospitals to use, resulting in a hospital account generating annual revenue to Precipio of approximately $200,000-500,000. With approximately 6,500 hospitals in the US market, this represents a significant market opportunity for Precipio.

About Precipio

Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment, initially the Yale School of Medicine, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit

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