TEST:

DetermaRx™

Our study confirms that S/MP pattern is a significantly worse prognostic factor for DFS in nsNSCLC and that there are significant differences in molecular features between these two different histopathologic patterns. qPCR-based assay could reliably identify patients with a worse prognosis in S/MP pattern, suggesting that such patients are most likely to benefit from personalized adjuvant therapy.

P=N/A; N=1000 --> 55 | Trial completion date: Jun 2024 --> Oct 2022 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Oct 2022; Non-safety related, reallocation of resources

Data suggests there is a 20-34% chance of reoccurrence for early-stage NSCLC. As well as EGFRm positive non-squamous NSCLC possess several clinicopathological and molecular factors identified as association with increased recurrence rate. In resectable NSCLC, the consequence of disease recurrence is a significant threat, many patients reoccur or die within 5 years.

Molecular risk classification may improve outcomes for early-stage NSCLC patients, particularly for stage IA patients. Current standard of care is potentially undertreating one-third of stage IA patients who may be at higher risk for recurrence and could benefit from additional treatment post-resection. Use of clinicopathologic features alone may lead to overtreatment by the current paradigm.

"Oncocyte Corporation...announced that the Advisory Panel for clinical diagnostic laboratory tests (CDLT) has unanimously recommended that starting January 2023, the Company’s DetermaRx™ test be cross-walked to CPT code 81522, currently priced at $3,873. Medicare (CMS) will consider this recommendation and is expected to post its preliminary decision in mid-September for public comments and issue a final determination in mid-November....Separately, the Company announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed the validity of a Local Coverage Determination (LCD) reconsideration request for broader coverage for DetermaRx to include risk-stratification (in conjunction with TNM staging) to assess the risk of recurrence for the early-stage NSCLC patient to determine the best course of action for patient management."

"Oncocyte Corporation...announced that the US Department of Veterans Affairs ('VA'), the largest integrated health care system in the United States, has awarded a Federal Supply Schedule Contract for the Company’s DetermaRx™ test."

In our cohort of resected, early-stage NSCLC patients, a 14-gene molecular risk stratification test identified a higher number of stage IA patients at high-risk for recurrence compared to the traditional NCCN criteria. 50% of patients without any NCCN risk factors were found to be high risk by molecular assay. Although adjuvant chemotherapy for patients with NSCLC stage IA is not currently recommended by oncology guidelines, utilizing molecular risk profiling may be considered to accurately identify patients with stage IA at increased recurrence risk who could benefit from adjuvant chemotherapy.

P=N/A; Not yet recruiting --> Recruiting

Investor Presentation

Oncocyte Corporation...announced the completion of the second part of the technology transfer under its revised Exclusive Sublicense Agreement with Burning Rock Biotech Limited...Per the agreement, Burning Rock has licensed Oncocyte’s proprietary risk stratification DetermaRx™ test in China, and is now poised to launch the test to the world’s largest early-stage lung cancer market.

"A subscription to REFINITIV is required to access document 94601350 | Page no: 01 | REPORT TITLE: "Burning rock biotech limited: Launch of early detection tests to reaccelerate” | AUTHOR: Alexis Yan, et al | DATE: 11/17/21"

Investor Presentation

No abstracts available

DetermaRx is a 14-gene molecular stratification test that has been validated in over 1400 patients, and outperformed NCCN criteria in identifying patients at high risk for mortaility from stage IA, IB, and IIA non-squamous NSCLC. Oncocyte now offers DetermaRx+EGFR testing to provide a complete molecular testing solution in early-stage NSCLC, guiding treatment selection of targeted therapy and adjuvant chemotherapy.

Conclusion Clinical adoption trends reveal that molecular risk classification is being utilized in the early-stage setting, particularly for stage IA patients. An extensively validated 14-gene expression assay that has previously been demonstrated to outperform NCCN high-risk features in assessing mortality risk reclassifies traditional clinicopathologic feature-based risk for many early-stage patients in the clinical setting.

" Reduction of recurrences with implementation of the 14-gene assay resulted in an average cost savings of $11,608/patient (potential systems savings of ~$450 million), even when including the cost of molecular risk stratification ($4000/patient) and of cisplatin-based adjuvant chemotherapy for molecular high- and intermediate-risk patients... Utilization of this predictive molecular risk stratification assay in the management of stage I-IIA non-squamous NSCLC has the potential to significantly reduce lung cancer costs in an era of targeted therapy and immunotherapy, while at the same time improving DFS and saving lives. Research Funding: Oncocyte Corporation"