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Burning Rock Details Launch Plans for Three New Oncology Assays in 2022

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NEW YORK – Burning Rock Biotech provided updates this week on its timelines for new product launches in 2022, which are poised to help the company enter several new areas of clinical cancer genomics and expected to contribute significantly to its growth in coming years.

During a call discussing the firm's third quarter financial results this week, CEO Yusheng Han disclosed that the company has finalized plans to bring the DetermaRx assay it licensed from US precision oncology firm Oncocyte to market next year.

A gene-expression based risk assessment test, the assay is intended to inform decisions about whether to treat early-stage lung cancer patients with chemotherapy or to avoid adjuvant treatment and surveil them over time.

Joining that test on the market will be Burning Rock's recently described minimal residual disease assay called BR Prophet, which takes a tumor-informed, patient-personalized approach. According to Han, the test has shown "very promising performance" with sensitivity on par with what has been shown in publications by companies like Natera that now compete in this market in the US.

Shannon Chuai, Burning Rock's chief operating officer, said that the company expects validation results in lung cancer to read out early next year.

This is the most immediately addressable market for MRD testing, she added, with recommendations now in place for relapse-risk prediction for early-stage non-small cell lung cancer patients by the 2021 Chinese Lung Cancer Clinician Consensus.

"We have seen a really rather dramatic change in [clinicians' interest] in MRD in the past few months. Last year around this time we didn't feel like the MRD market was ready in any way. But more recently, especially among lung clinicians … [there has been stronger] interest in MRD-related products," Chuai said.

Most interest so far is still in the research and drug-development realm, she added. "There [is] increasing interest in MRD-driven adjuvant therapy studies for drug development and we think BR Prophet will be very well positioned to collaborate with our pharma partners, because most of the liquid biopsy [tests] available in the China market are fixed panels, so it will be an innovative technology."

"We do have pretty high hopes [for the clinical] market. But frankly speaking, we are not 100 percent sure how fast the adoption rate will be among Chinese clinicians," she said.

That said, Burning Rock is hoping some of the assay's "built-in utility" will drive clinical adoption. "From what we have observed over the past few months, it's becoming more and more promising because the utility in these early-stage patients is so significant, scientifically," Chuai said.

According to Chuai, the company is also working to extend its validation into other solid tumors, including colon cancer, esophageal cancer, and gastric cancers, expecting a readout of results in 2022 from retrospective cohorts.

In a conference call presentation, Burning Rock also noted that it is developing a second, tumor-agnostic MRD assay analyzing both mutations and methylation signals.

"In terms of tumor-informed versus a fixed panel, they each have their pros and cons, but we are seeing clearly that in terms of the most important utility — longitudinal monitoring for surveillance of relapse in early-stage patients — most clinicians in China think that … negative predictive value is the most important thing for this application," Chuai said.

In other words, sensitivity is more important than specificity, she added, since doctors want to make sure all MRD-negative patients really are free of cancer. In that situation, tumor-informed methods show clear advantages, at least right now.

However, it does have cons, she said, including an inability to detect cancer in patients who develop second primary tumors and a much slower turnaround time.

During the call, Han said that preparations have also been going well for the 2022 launch of Burning Rock's six-cancer early detection assay, the first iteration of what could eventually expand to a 22-cancer screening test.

Han said Burning Rock is confident that it will have signed on six hospital customers by the end of this year but cautioned that multi-cancer early detection is a new product category in the Chinese market, one where "consumers, as much as doctors, are the real customer." As such, the company is planning on implementing a patient education campaign in collaboration with hospitals and doctors as it rolls the test out next year.

With the test launched, the company plans to begin a prospective/interventional study in the intended use population in the first half of 2022, a first step toward seeking regulatory registration for the assay in China.

Chuai said that another key update has been Burning Rock's completion of accrual for a pilot case control validation study that includes over 2,000 participants, called PROMISE, and expects to release initial data in the first half of next year.

The firm also expects its first data readouts from the PREDICT study of its next-in-line nine-cancer screening assay by the end of 2022. That trial is recruiting more than 14,000 participants, with 30 centers contributing to enrollment.

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