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Indian biotech may have discovered a diagnostic test for early cancer detection

June 10, 2021

Existing tests for the early diagnosis of cancer have been fraught with challenges such as low accuracy and false negatives.
Researchers working at an Indian biotech startup tried to read a genetic signature they believe to correlate with cancer.
The team used a controversial type of stem cells known as VSELs to create a blood test known as HrC, which they say can detect different types of cancer with precision accuracy.

Researchers based in India have demonstrated an innovative new method to detect multiple types of cancer in their early stages. The work was published in the peer-reviewed Stem Cell Reviews and Reports journal in May 2021. The clinical trial in this study involved 1,000 participants. Cancer is one of the leading causes of death worldwide, accounting for one out of every six deaths. It kills more people (each year) than HIV-AIDS, malaria, and tuberculosis combined. There were an estimated 19.3 million new worldwide cancer cases in 2020 and nearly 10 million deaths. The number of new cases is expected to reach nearly 30 million and cause almost 20 million deaths by 2040. While cancer treatment has improved, early detection remains a challenge. A diagnostic tool that could flag cancers early could be the missing link to drastically reduce the number of deaths and prevent the suffering and financial ruin that cancer causes in families. So far, researchers have focused on two techniques for early cancer detection. The first one has looked for circulating tumor cells and the other involves detecting circulating cell-free tumor DNA (ctDNA) materials in blood. Both methods have had limitations in that a small sampling of blood may not contain enough indicative materials, thus reading to false negatives. These techniques have also shown low accuracy in detecting cancer at the early stages (when clinical intervention would be most effective). The new discovery by Indian researchers might be the most promising cancer detection breakthrough so far, promising a 99% accuracy in the early identification of 25 different types of cancer. The research team leveraged prior work on stem cells to make the discovery. Stem cells are the body’s basic raw material – templates from which specialized cells are generated. They have been extensively studied particularly by researchers in the growing field of regenerative medicine. The most valued stem cells are those that have pluripotency (the ability to turn into any kind of cell in the body). These can be used to cure a wide range of ailments, including tissue and organ damage. There are two types of pluripotent stem cells: embryonic cells and induced pluripotent stem cells. Embryonic stem cells are found in the undifferentiated inner mass cells of a human embryo. In 2006, a Kyoto University research team led by Dr. Shinya Yamanaka discovered a method to create induced pluripotent stem cells (IPSCs) using genetic reprogramming. Dr. Yamanaka won the 2012 Nobel Prize in Medicine for this work. A third type of pluripotent stem cell was isolated by Polish-American scientist Mariusz Ratajczak in 2006. These were referred to as Very Small Embryonic Like stem cells (VSELs). However, there has been widespread controversy regarding their existence because some scientists have been unable to extract them. Proponents have argued that this disagreement emanates from the fact that these cells are extremely small and very difficult to isolate, not because they are non-existent. The Indian team used this controversial type of stem cell in the research. The researchers found that the peripheral blood of cancer patients had a higher number of VSELs compared to healthy individuals. The team also determined that the expression of a transcription protein known as Oct4a varied in correspondence to the stage of cancer. The test – named HrC – was developed by nanotech scientist Vinay Kumar Tripathi (who is based in Mumbai but works at the Singapore-based Tzar Labs Pte Ltd) in partnership with Indian biotech firm Epigeneres Biotechnology Pvt. Ltd. “We can early-detect all types of cancer, even before tumor formation, from a simple blood test. It’s also the first prognostic test for cancer in the world. Not only can we tell you don’t have cancer, but we can also safely rule out the risk of cancer for the following year if your HrC marker falls in the safe zone. We envisage a world where one needs to do the HrC test once a year, and we will catch cancer either at stage 1 or prior,” said Ashish Tripathi, CEO at Tzar Labs. The company now aims to launch HrC test kits in India by October this year after securing regulatory approval. They have filed for patents in India, US, Europe, Japan, South Korea, Singapore, and China. The group is also in talks with investors to raise capital to fund large clinical trials involving 10,000 to 20,000 subjects in Western markets. The science around VSELs could remain unsettled for longer. But if the HrC test is validated by larger clinical trials, it could be among the first contenders for accurate diagnostic testing of cancer from a draw of blood (liquid biopsy). “Any test that can reliably detect cancer very early is a game-changer. This would not only allow us to apply therapies while cancers are at highly curable stages but would also allow us to monitor the progress of treatment without exposing the patient to unnecessary toxicity of overtreatment. If validated, this blood test, with high reported accuracy and reproducibility, that can diagnose all cancers, would represent a major breakthrough,” said Dr. Ashish Kamat, a professor of urologic oncology and cancer research at the MD Anderson Cancer Center in Houston, TX.

References: https://www.livemint.com/science/health/biotech-startup-reports-early-cancer-detection-breakthrough-11620326077485.html

Indian biotech may have discovered a diagnostic test for early cancer detection

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