Earlier this year, Medgadget heard from Precipio CEO Illan Danieli on how his company uses advanced diagnostics and personalized medicine to reduce the prevalence of cancer misdiagnosis. Over 1 million patients globally and about 200,000 patients in the U.S. are annually diagnosed with non-small cell lung cancer (NSCLC). This week, the company announced the launch ICEme, a new kit leveraging the company’s proprietary, ultra-sensitive ICE-COLD PCR (ICP) liquid biopsy technology.
With the new kit, physicians can identify patients eligible for TKI (Tyrosine Kinase Inhibitor) therapies through analysis of tumor DNA for critical mutations in EGRF exons 18, 19, 20, and 21. The presence of these mutations indicates patient eligibility for targeted therapies and therefore complements Precipio’s existing TKI-resistance detection, kit creating a full suite of sequential lung-cancer tools critical to determining patient treatment. The new kit is available on qPCR and Sanger diagnostic platforms.
EGFR mutations are present in 10-15% of lung cancers and identify tumors that may respond well to TKI therapies which target these mutations. TKI therapies are so effective at reducing a patient’s tumor burden that the National Comprehensive Cancer Network (NCCN) requires that all lung cancer patients are evaluated for EGFR mutations, which is where Precipio’s new ICEme kit plays a role. However, studies show that 50% of patients on TKI therapies may develop resistance to the therapy. This is where Precipio’s TKI-resistance detection kit plays a role, checking if patients are exhibiting a resistance to TKI therapy (exon 20 T790M and C797S resistance mutations) and need to be transitioned to an alternative treatment.
Compared to other sequencing technologies, ICP offers a 500-fold improvement in sensitivity, with detection levels as low as 0.1% on plasma samples and uses liquid instead of solid tumor biopsy. A significantly lower cost compared to competing assays represents one of Precipio’s advantages in realizing strong adoption.
“The new EGFR kit represents the completion of an end-to-end liquid biopsy solution for lung cancer patients who require both initial tumor evaluation, as well as monitoring during therapy, to ensure their treatment is most effective,” said Ilan Danieli, CEO. “With each new test we create on the ICP platform, a new segment of cancer patients may benefit from its use, increasing the revenue potential for adopters of the platform. We have strategically prioritized expansion of the menu which we expect will result in higher adoption rates by large cancer treatment centers, an increasing number of which are presently evaluating commercial utilization of ICE-COLD PCR.”