Ultra-sensitive enrichment kit enables development of low cost detection tests, allowing optimized patient
treatment
NEW HAVEN, Conn., May 17, 2018 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ:PRPO), today announced the launch of two additional ICEme™ kits using its
proprietary ICE-COLD PCR™ liquid biopsy technology. The new RUO kits enable the detection of mutations in KRAS Exons 2 & 3, which
include important predictive and prognostic biomarkers, and are available on both qPCR and Sanger molecular diagnostic
platforms.
The Challenges of Pancreatic Cancer
Over 55,000 patients are diagnosed with pancreatic cancer each year in the US; approximately 80% will die each year. The 5-year
survival rate for stage I pancreatic cancer is ~14%, a number that drops to 3% for stage III patients, and 1% for stage IV
patients1. Only 7% of patients are diagnosed in early stages, when the disease is still localized2.
Treatment for pancreatic cancer includes surgery, radiation therapy, and chemotherapy. While chemotherapy can often be effective
in treating the patient, the success may depend on the genetic mutations present in the tumor. As Dr. Victoria Kim writes in her
paper Early Detection of Pancreatic Cancer, “...current standards for diagnosing pancreatic cancer
remain too invasive and too costly for widespread screening for pancreatic cancer.”
Precipio’s new, ultra-sensitive ICP kit provides a solution with its groundbreaking non-invasive, low-cost enrichment technology
for laboratories to develop tests for screening and monitoring pancreatic cancer patients via blood samples for important,
actionable mutations critical to determining treatment.
Clinical Significance of KRAS Mutation Detection
With KRAS mutations presenting in over 90% of pancreatic cancers3, KRAS is an impactful gene that acts as an on/off
switch in cell signaling. When it functions normally, it controls cell proliferation. When mutated, negative signaling is
disrupted, causing cells to continuously proliferate, and often develop into cancer4.
While no KRAS targeted therapy has yet proven to be effective for pancreatic ductal adenocarcinoma (PDAC), KRAS is an important
prognostic indicator that can provide valuable information on optimal patient treatment plans.
Clinical & Economic Value proposition
The ICP kits will be priced at approximately $100 per specimen, a fraction of competing liquid biopsy tests. Laboratories
running ICP can apply tier-1 approved codes to bill for the tests at approximately $400 (based on Medicare’s 2018 Clinical Lab
Fee Schedule).
The breakthrough clinical value of this dramatic cost reduction is the ability to test sequentially and
repeatedly, increasing the likelihood of identifying the KRAS mutation soon after it appears. This enables the physician to
optimize treatment in real time, and react to the genetic signals that may precede potential patient
deterioration.
The economic value lies in the ability of the treatment center to generate new revenue by now offering an in-house laboratory
developed test to screen pancreatic patients, tests which, absent ICP, are being sent out to external diagnostic labs.
Relevance in other cancers
In the coming quarters, Precipio plans to launch additional kits targeting other forms of cancer where KRAS is relevant,
including colorectal (CRC) and non-small cell lung cancer (NSCLC) - also among the most frequent causes of cancer mortality in the
world5. KRAS mutations appear in 25% of non-small-cell lung carcinomas (NSCLC), and in 39% of colorectal cancers
(CRC)6.
Treatment success using various chemotherapy agents for treatment of metastatic colorectal cancer depends on the absence of a
mutation in the KRAS gene; the treatment is ineffective if the mutations are found in the KRAS gene7. Therefore, the
ability to provide recurring patient monitoring for the presence of a mutation in KRAS is essential to ensuring effective
treatment.
“This is yet another clinically-relevant application of our ICP technology to help physicians gain better insight into the
biology of the patient’s tumor through unique, targeted tests,” said Ilan Danieli, President and Chief Executive Officer of
Precipio. “Pancreatic cancer patients, as well as lung and colorectal cancer patients can benefit from this non-invasive and
economically sensible test which, we hope, may ultimately raise the survival rate for patients with these cancers,” Mr. Danieli
continued.
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 other financial projections 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 Annual
Report on Form 10-K for the year ended December 31, 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.
Inquiries:
investors@precipiodx.com
+1-203-787-7888
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1 Source: American Cancer Society
2 Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4391769/
3 Source: http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.e23042
4 Source: https://en.wikipedia.org/wiki/KRAS
5 Source: https://www.wcrf.org/int/cancer-facts-figures/worldwide-data
6 Source: https://www.ncbi.nlm.nih.gov/pubmed/24331409
7 Sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5817724/ & https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901795/
