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Datar Cancer Genetics Expands Business from Treatment Monitoring to Dx and Screening

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NEW YORK – Indian liquid biopsy firm Datar Cancer Genetics has traditionally used its technology to develop theranostic tools to measure cancer patients' reactions to certain treatments.

But with the recent launch of its Trublood tests for prostate cancer and pan-cancer detection, as well as its TruCheck screening tool, the company, based in Nasik in the state of Maharashtra, is expanding its reach into cancer diagnosis and screening.

Datar was founded in 2013 to explore how to use genomics across a wide arena of clinical domains, including cancer, neonatal and reproductive health, and cardiovascular preventive health. As it researched these diseases further, it decided to narrow its focus to oncology and create tools using "advanced technologies where we could use genomics to improve clinical outcomes" for cancer care, Datar Executive Director Vineet Datta said.

Its products utilize a variety of testing modalities, he said. Next-generation sequencing, multiplex PCR, immunohistochemistry, pharmacogenetics, and transcriptome data analysis are used in more than 100 oncology solutions available in India, with some also sold in the EU and the UK — the company currently has labs in India, Germany, and the UK.

One of its key tests, Exacta, provides "encyclopedic tumor analysis" drawing on both cell and molecular data to guide clinicians toward actionable therapy options, Datta said.

Exacta looks at the DNA and RNA present in a tumor, the expression pathways, pharmacogenetics, and the tumor mutational burden to determine treatments that are "higher on the efficacy but lower on the toxicity" for patients, he explained.

The test is particularly useful in cases where patients have failed therapy, where the cancer has relapsed, or in cancers that are difficult to treat, including gallbladder and pancreatic cancers and brain tumors.

The Exacta test can be offered as either a combined tissue and blood test or as a blood test alone, he said. A real-time blood sample is important, since tissue samples can sometimes be old or outdated, he added.

Once the tumor data is collected, via methods such as sequencing and immunohistochemistry, the different data points are analyzed by bioinformatic tools, which can either come as standard or bespoke platforms, depending on a lab's needs. The data undergoes an algorithmic review that combines DNA, RNA, cell-based, immunochemistry, and pharmacogenetic data to identify the appropriate treatment.

That information is reviewed by the company's clinical reporting team and formatted into the final report that is given to the oncologist.

Datar's focus has been on looking at "the cancer microenvironment from a variety of different … locations," not just DNA fragments, Datta said. It includes investigating "cancer pathways and looking at downstream analysis for some of those pathways," he added.

The company also offers other assays, including its CE-marked CellDx test that analyzes FFPE tumor tissue using next-generation sequencing and immunohistochemistry to monitor the efficacy of targeted therapies and immunotherapies, as well as its Cancertrack test that looks at cell-free DNA to determine qualitative and quantitative changes in targeted genes.

But in addition to treatment monitoring tests, over the last two years, Datar has expanded the use of its proprietary technology to diagnosis and screening, including one test that has launched already and one that is coming in the next few weeks.

The firm's Trublood testing line, which includes a prostate cancer-specific test and a pan-cancer test, is commercially available in the EU, UK, and Asia Pacific, with plans to expand to the US in the next year. It relies on the collection of circulating ensembles of tumor-associated cells, or C-ETACs, to diagnose cancer.

While it's not the first company to use circulating tumor cells for diagnosis, its integration of C-ETACs is unique, Datta said. The clusters "are not limited to just circulating tumor cells; they've also got additional cells around the primary tumor cells," he said. C-ETACs include circulating tumor cells, or CD45-negative cells, along with CD45-positive and CD8-positive cells, such as tumor-associated macrophages and tumor-associated leucocytes, along with cancer stem cells.

Datta compared identifying a cell of interest in a milliliter of blood via traditional methods as looking for "a needle in a barn," removing a small, fragile cell from a highly complex environment. Scientists often use physical means to push a cell through a system, which may identify cancer cells but also results in large losses, Datta said.

The company's proprietary technology, however, creates a microenvironment that causes normal cells to die off, leaving just the cancer cells available for perusal. The technology uses a special media that induces cell death for normal cells, Datta said.

In a study published last year in Cancer Cytopathology, researchers analyzed samples from 9,416 patients who had prior diagnoses of various cancers, 6,725 patients who had suspected cancers, and 13,919 asymptomatic people who had an age-associated elevated risk of cancer but negative findings on cancer screening tests.

According to the paper, once samples are processed in the special media, viable malignant tumor cells and their clusters are harvested for identification of C-ETACs and CTCs by immunocytochemistry. Using ICC profiling, the cells are characterized for organ-specific and subtype-specific antigens to determine the tissue of origin.

C-ETACs were detected in 92 percent of samples of various cancers and in nonmetastatic cases as well as in 93 percent of metastatic cases. To determine if ICC profiling provided accurate representation of organ of origin and subtype, they evaluated C-ETACs from an additional subset of samples, finding 93 percent concordance.

In the paper, the researchers noted that "the high detection rates of C-ETACs across the entire cancer cohort were consistent with confirmed diagnoses of cancer, and the baseline detection rates in individuals with benign conditions and in asymptomatic individuals indicated high specificity."

In a sample of 13,919 individuals who formed the baseline-risk subgroup — where there were no aberrant findings in cancer markers or on low-dose computed tomography, mammography, or Pap smear — the detection of C-ETACs was 4 percent.

Researchers added that "C-ETACs retained and faithfully conveyed the molecular and functional characteristics of the tumor tissue of origin, irrespective of metastatic status or prior therapy status, and had minimal intermarker interference."

If a physical biopsy isn't possible — or if a finding is suspicious, but a clinician doesn't want to perform another biopsy — the Trublood test can be used to determine whether a patient needs further procedures. Datta cautioned that the test is not a substitute for a physical biopsy but rather can help risk stratify patients who need an additional biopsy and those who don't.

In the COVID-19 era, the test may be particularly useful for reducing backlogs in hospitals, he said. Since many patients were unable to visit hospitals during the pandemic, significant backlogs in biopsies and other procedures developed.

Using Trublood could help cut down on some of those backlogs and reduce unnecessary treatments. "What we don't want are the patients who don't have a cancer in that space to be taking up time and space from those patients who have cancer," he said. "It's a way in which you could potentially smartly triage … individuals if you have limitations of resources."

Upon reviewing the study, Hsian-Rong Tseng, a professor in the department of molecular and medical pharmacology at the David Geffen School of Medicine at the University of California, Los Angeles, said that it involved a "very unique method." However, he added that the method "could be very laborious," and he wasn't sure how reproducible it was.

He also noted that the current data only showed correlation and that he couldn't see the clinical utility. The data would need to be further linked to clinical utility, he said, defining "how you use the numbers to tell me about the cancer."

The Trublood test originally received CE marking in March for prostate cancer and was later expanded to all cancers. The prostate cancer test was also recommended in the UK's National Institute for Health and Care Excellence's MedTech Innovation Briefing last month.

The briefing echoed Datta's use case for the test, noting that the "intended place in the care pathway" for Trublood Prostate would be "either to triage symptomatic patients suspected of prostate cancer prior to undergoing a conventional invasive prostate biopsy or to obtain a diagnosis in symptomatic people suspected of prostate cancer who are otherwise unfit for a prostate biopsy in primary, secondary, and tertiary settings."

According to the company's clinical case control study, the prostate cancer test has a sensitivity of 96 percent and specificity of nearly 98 percent. It has a turnaround time of 10 days and is intended for use in patients with enlarged prostates or elevated serum prostate-specific antigen levels, or any other urological symptoms.

Meantime, its TruCheck multicancer screening tools, using similar technology as Trublood, will be launching this month. The tools can identify cell clusters in asymptomatic people who are at higher risk for developing cancer.

In a study published in Cancer Prevention Research earlier this year, researchers from Datar, Avinash Cancer Clinic and Kokilaben Dhirubai Ambani Hospital in India, Worcester Polytechnic Institute in the US, and Broomfield Hospital in the UK found that asymptomatic people who had detectable C-ETACs had a 230 percent higher one-year cancer risk compared to people where C-ETACs were undetectable.

In symptomatic patients suspected of cancer, C-ETACs were detected in 93 percent of cases where cancer was eventually confirmed. The researchers found that the test "can significantly minimize radiological or invasive screening in the majority of individuals who do not have any increased risk."

Some of the TruCheck tools will be for specific cancers, including breast and prostate cancer, while others will include multiple analytes for multiple cancers, Datta said.

The test can also lead to early detection of cancer in asymptomatic patients, which Datta said "takes screening to the next level."

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