NEW HAVEN, Conn., March 20, 2018 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ:PRPO), announced today it has successfully incorporated the use of High Resolution Melt (HRM) technology into its ICE COLD-PCR™ (ICP) kits, substantially improving its liquid biopsy testing cost and time efficiency.
Customers using Precipio’s ICP for liquid biopsy may enjoy an additional reduction in their cost per specimen, potentially improving their margin by an estimated 25-50%, depending on the ratio of positive/negative cases).
This further strengthens Precipio’s ICP platform as what we believe to be the industry’s leading, most cost-effective technology for liquid biopsies.
The use of HRM as a screening tool enables laboratories to quickly and effectively rule out the patient samples that turn out negative for a genetic mutation in the region of interest. Obtaining that information through a simple and quick up-front step potentially eliminates the need to perform more complex and costly genetic mutation detection (e.g. next generation sequencing), significantly reducing the cost of testing and the wait time involved, from 7-10 days1, to a matter of hours.
Much like ICP, HRM can be applied to any of the downstream technologies ICP works on, such as RT-PCR, Sanger, and or NGS (expected 2nd half of 2018).
“The incorporation of HRM into our kits further sets ICP apart from all other competitors. While competitors focus on large, expensive panels, not easily reimbursed, our low-cost, efficient, reimbursable and targeted panels can now yield a same-day result (for negative cases),” said Ilan Danieli, Precipio’s CEO. “Our customer pipeline continues to grow as more laboratories realize the clinical and economic value that ICP brings them.”
What is High Resolution Melt (HRM)
HRM is a targeted screening tool used for the detection of genetic mutations in DNA. This technique has three main advantages over alternative mutation detection technologies:
- Cost effective – HRM analysis utilizes an inexpensive fluorescent dye to enable the detection of a genetic mutation.
- Speed – HRM testing requires approximately 2-4 hours to generate results, compared to 7 days for most laboratories using other gene sequencing technologies.
- Simplicity – HRM assays are simple, and don’t require laboratory technician expertise, enabling easy and quick adoption by facilities that do not have the staff expertise necessary for higher complexity gene sequencing.
HRM in Laboratory Work-Flow
The current process for identifying mutations in a blood sample involves two steps:
- Step 1: Enrichment. This step involves enriching the sample using ICP to amplify the tumor DNA relative to the normal DNA.
- Step 2: This step involves the actual genetic sequencing and analysis to identify the specific mutation.
Clinical industry data shows that often 50%2,3 or more of the specimens are negative, meaning there are no mutations present. However, to arrive at that result, both steps need to be completed, incurring both the time and cost of both those steps.
HRM enables laboratories to screen for those mutations in step 1 (enrichment), and provide a yes/no answer as to the presence of a mutation. Once step 1 is completed, the samples that have obtained a “negative” answer require no further testing, thus avoiding step 2. Only the specimens where the HRM test yielded a positive answer proceed to step 2 to determine the actual mutation.
Economic Advantage
The incorporation of HRM essentially enables laboratories to avoid running Step 2 for negative specimens (often representing 50% of cases). Each test run requires the utilization of expensive equipment; expensive reagents and controls required to run the test; and the time of laboratory technicians. By stopping the process at Step 1 for a portion of the cases, laboratories can report the same results quick, and reduce their costs by avoiding step 2. We believe this represents a 25-50% savings in cost of goods, as well as a reduction of approximately 40% of labor time per test, for customers who use our HRM-enabled ICP kits.
Clinical Advantage - Results in Hours, not Weeks
HRM may also substantially reduce results turn-around on at least 50% of the samples. Oncologists (and their patients) typically wait 7-14 days to receive molecular testing results critical to informed treatment decisions.
Laboratories can report back to clinicians within hours on cases that are negative for mutations. This potentially enables patients to be placed on the correct therapy within hours, rather than waiting weeks for results. In cancer, similar to other critical illnesses, time may be a critical factor in determining treatment; the sooner the patient is placed on the appropriate therapy, the higher the chances of success, potentially.
Impact on Precipio’s Business
The incorporation of HRM into our ICP kits further improves the economic and clinical value of ICP, our liquid biopsy platform, and we believe it places ICP at the forefront of the liquid biopsy alternatives available on the market.
We believe this unique capability will increase our platform’s competitive advantage and enable improved market share growth as hospitals and labs benefit from the improved ability to compete against much larger national laboratories and tertiary institutions.
HRM-enabled ICP kits currently available can impact patients with breast, gastric, lung, colon and pancreatic cancers, affecting more than 5 million patients in the US. Assuming a testing frequency of once a year (likely conservative in cases such as lung cancer, where testing is conducted 3-4 times per year), this equates to a potential domestic market of approximately $4-5B annually.
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 such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements,” within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words “anticipate,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “should,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company’s definitive proxy statement filed on May 12, 2017, the Company’s Quarterly Reports on Form 10-Q for the quarters ended June 30, 2017 and September 30, 2017, the Company’s prior filings and from time to time in the Company’s subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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1 Based on company experience and internal data, average industry turn-around-time for molecular testing is 7-10 days.
2 J.L. Kuiper, D.A.M. Heideman, E. Thunnissen, M.A. Paul, A.W. van Wijk, P.E. Postmus, E.F. Smit, Incidence of T790M mutation in (sequential) rebiopsies in EGFR-mutated NSCLC-patients, Lung Cancer, Volume 85, Issue 1, 2014, Pages 19-24, ISSN 0169-5002, https://doi.org/10.1016/j.lungcan.2014.03.016.
3 Ko, Ryo et al. “Frequency of EGFR T790M Mutation and Multimutational Profiles of Rebiopsy Samples from Non-Small Cell Lung Cancer Developing Acquired Resistance to EGFR Tyrosine Kinase Inhibitors in Japanese Patients.” BMC Cancer 16 (2016): 864. PMC. Web. 19 Mar. 2018.