Express | Blood test found "King of Cancer", unique early screening test was recognized by FDA as a breakthrough medical device

▎ WuXi AppTec content team editor recently, Bluestar Genomics announced that the U.
S.
FDA has granted its breakthrough medical device designation for non-invasive pancreatic cancer early screening for screening pancreatic cancer in patients with newly diagnosed diabetes.

This test aims to detect and treat pancreatic cancer as soon as possible by detecting the epigenetic characteristics of circulating cell-free DNA in blood samples taken during ordinary blood tests, and to improve patients' chances of survival.

Pancreatic cancer is called the "king of cancer" because it is difficult to treat and is highly lethal.
One of the reasons why it is difficult to treat is that the symptoms of early pancreatic cancer are mild, and most patients are already at an advanced stage when they are diagnosed.

Research data shows that among the 60,000 pancreatic cancer patients diagnosed in the United States, close to 25% of the patients had new-onset diabetes before pancreatic cancer was diagnosed.

However, there is currently no recommended early screening test for pancreatic cancer.

The early screening test developed by Bluestar Genomics is a liquid biopsy designed based on circulating cell-free DNA combined with machine learning.

This liquid biopsy is based on epigenetic changes in the pancreatic cancer genome.

A variety of genes related to the development and growth of the pancreas and cancer have different levels of hydroxymethylation.

After the oncogene KRAS is activated or the tumor suppressor gene TP53 is inactivated, the hydroxymethylation level of these genes will change significantly.

The liquid biopsy designed by Bluestar Genomics detects early pancreatic cancer by detecting changes in a biomarker called hydroxymethylcytosine (5hmC) on circulating cell-free DNA.

The feasibility of this detection strategy has been verified in many scientific papers, including a proof-of-concept study published on Nature Communications last year.

Currently, the company is planning to conduct a large-scale clinical trial to verify the performance of early screening for pancreatic cancer in patients with newly diagnosed diabetes.

The breakthrough medical device designation allows Bluestar Genomics to communicate with the FDA in a timely manner during the process of test development, verification, and approval.

"Too late diagnosis deprives patients of the opportunity to receive potential curative therapies, which significantly affects survival rates.

" said Dr.
Kelly Bethel, Chief Medical Officer of Bluestar Genomics .
"Early diagnosis allows patients to receive surgical treatment with curative potential.

Therefore, early Testing is essential to give patients better treatment options and improve prognosis.

"Reference: [1] Bluestar Genomics Receives FDA Breakthrough Device Designation for First-of-Its-Kind Pancreatic Cancer Screening Test.
Retrieved April 1, 2021, from : This article aims to introduce the progress of medical and health research, not to recommend treatment options.

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