July/August 2024 • PharmaTimes Magazine • 6

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Leuko device to monitor cancer patients during chemotherapy

Leuko, founded by researchers at the Massachusetts Institute of Technology (MIT), has developed an at-home white blood cell monitor to help doctors non-invasively monitor cancer patients’ health during chemotherapy.

The PointCheck device provides an easy-to-use way of recording immune health for doctors and optimising cancer treatment for patients.

In 2020, it was estimated that cancer was responsible for more than 18 million cases worldwide, according to Cancer Research UK.

Chemotherapy works to destroy cancer cells, which can also destroy patients’ immune cells, leading to tens of thousands of cancer patients with weakened immune systems every year, putting them at risk of contracting infections.

In an attempt to strike a balance between providing enough chemotherapy to destroy cancer while not allowing the patient’s white blood cell count to get so low, Leuko’s PointCheck device uses light to look through the skin at the top of the finger nail, using artificial intelligence to analyse and detect when white blood cells reach low levels without needing a blood test.

First created in 2015, MIT researchers conducted a study of 44 patients in 2019, which demonstrated that PointCheck successfully detected when white blood cell levels dropped below a critical threshold with minimal false positives.

In a larger study of 154 patients, the PointCheck device demonstrated easy use at home by unsupervised patients to get immune information to doctors.

The team also believes that the device could potentially be used in the future to monitor other biomarkers in the blood for other conditions.

“Other patient populations include patients with multiple sclerosis, autoimmune diseases, organ transplants and patients that are rushed into the emergency room,” said Carlos Castro-Gonzalez, co-founder and chief executive officer, Leuko.

Leuko co-founder and chief technology officer, Ian Butterworth, commented: “We expect this to bring a clear improvement in the way that patients are monitored and cared for in the outpatient setting.”

Later this year, a pivotal study will be conducted by the company to register for US Food and Drug Administration approval.


US researchers develop AI liquid biopsy test to help identify lung cancer earlier

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Researchers from the Johns Hopkins Kimmel Cancer Center and other institutions have developed and validated a liquid biopsy test using artificial intelligence (AI) to help identify lung cancer earlier.

The new study demonstrated that the new blood test could help accelerate lung cancer screening while reducing death rates.

Currently the leading cause of global cancer incidence and death worldwide, lung cancer accounts for an estimated two million diagnoses and 1.8 million deaths annually.

For the last five years, researchers have developed a test to detect patterns of DNA fragments found in patients with lung cancer.

Participants with and without cancer who met the criteria for low-dose computed tomography (CT) were recruited to receive the blood test to determine which patients were most at risk and would benefit from a follow-up CT screening to help overcome issues regarding appointments, such as the time it takes to arrange and go to an appointment, as well as low-dose exposure to radiation.

The AI software was trained to identify the specific patterns of DNA fragments seen in the blood of 576 people with or without lung cancer, which was then verified to work in a second group of 382 people with and without cancer.

The team found that the test has a negative predictive value of 99.8%, meaning that only two in every 1,000 people may be missed and have lung cancer. The team plans to seek approval from the US Food and Drug Administration for lung cancer screening and plans to determine whether a similar approach could be used to detect other types of cancer.

Victor Velculescu, professor of oncology and co-director, cancer genetics and epigenetics programme, Johns Hopkins Kimmel Cancer Center, commented: “The test is inexpensive and could be done at a very large scale.

“We believe it will make lung cancer screening more accessible and help many more people get screened. This will lead to more cancers being detected and treated early.”