A new breakthrough in liquid biopsy! Clinical study of salivary ctDNA detection in lung cancer

Release date: 2016-02-24

A "liquid biopsy" that can detect lung cancer biomarkers in saliva is becoming a reality. This non-invasive method is capable of detecting circulating tumor DNA in saliva, significantly reducing the time to wait for biopsy results, and reducing the patient's cost of treatment and the inconvenience of testing.

At the 2016 Annual Meeting of the American Association for the Advancement of Science (AAAS), Dr. David TW Wong, Professor Felix and Deputy Director of Research at the University of California School of Dentistry, Professor Mildred Yip, discussed a prototype of a new device called Electric Field-Induced Release. And measuring device (EFIRM), which detects biomarkers of non-small cell lung cancer (NSCLC) in saliva.

According to Dr. Wong, this device has high accuracy compared to current sequencing technologies and can help in the clinical treatment decisions of tyrosine kinase inhibitors (TKIs) in NSCLC patients.

Dr. Wong said that the device can detect EGFR mutations in patients with NSCLC, and the results are identical to the genotypic analysis of biopsy tissue. This device can detect the most treatments for TKIs (such as gefitinib or erlotinib). Common EGFR gene mutations.

"The first indication for this new test will be lung cancer," Dr. Wong said. "The main type of lung cancer is non-small cell lung cancer, and 20% of NSCLC carries EGFR gene mutations that can be effectively treated with gefitinib, which can prolong the patient's 1-1.5 year survival."

This test is not limited to NSCLC. "After lung cancer, any other human cancer can be detected because circulating tumor DNA is widespread," he said. "We found that ctDNA is distributed in saliva, and EFIRM is a technique that can detect these ctDNAs with near-perfect sensitivity."

Dr. Wong and his team are currently investigating the ability of liquid saliva technology to detect genetic mutations associated with oropharyngeal cancer.

Dr. Wong pointed out that EFIRM is by far the only technology that can detect ctDNA in saliva.

In addition to non-intrusive testing, the two main "selling points" of this technology are the speed at which test results are obtained and the lower cost.

For example, a biopsy result may take a few days to reach a clinician for about $2000. The results of the mutation analysis take 2 weeks to be sent out at a cost of $450.

In contrast, according to the researchers' results, it takes only 1-10 minutes to collect saliva, and the analysis time is less than 10 minutes. The analysis results are sent to the clinician through the network within a few seconds. The entire testing process costs less than $25.

Dr. Wong explained that this technique can be used for immediate testing or as a reference for laboratory testing. “Instant detection is used in the clinician's office to detect ctDNA in a drop of blood sample or saliva sample within 10 minutes. If the mutation is positive, a TKI prescription can be issued so that the patient can start treatment immediately.”

“Patients don’t have to wait for 2 weeks and don’t have to go through invasive bronchoscopy, saving thousands of dollars,” Dr. Wong added.

Ongoing research and clinical trials

Making non-invasive liquid biopsies a reality has been the goal of many researchers for many years, and the use of circulating tumor cells can gain more boost in cancer treatment.

Research in this area has been ongoing because it is believed that ctDNA has the effect of screening and diagnosing, monitoring treatment response, detecting small residual lesions, and resistance mutations that occur in targeted therapies.

For example, a recent study found that analysis of single cells in patients with metastatic androgen-resistant prostate cancer is feasible, and this test can be used to assess tumor heterogeneity. The assessment results in turn can guide treatment decisions.

However, most studies use blood samples to obtain ctDNA instead of saliva.

Dr. Wong suggested that their current study should be considered a screening tool or a risk assessment tool for symptomatic patients and is not a substitute for current biopsy. “When we have other data, this detection method can be used for diagnosis when appropriate.”

Clinical trials of routine assessment procedures will be conducted in China and Taiwan in the middle of this year. “Compared with the West, the incidence of lung cancer in Asia and the mutation rate of the driving gene EGFR are three times higher.” Dr. Wong explained, “This technology is global, so we plan to slowly carry out routines in other parts of the world. Evaluations, especially after successful clinical trials in Asia, are expected to produce results in early 2017."

references

Roxanne Nelson, BSN, RN, Saliva Test for Lung Cancer, Medscape, February 19, 2016

Source: Medical Pulse

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