COMPANY:

Oncocyte

"Oncocyte Corp...announced that Chief Executive Officer Josh Riggs and Chief Financial Officer Andrea James will attend “J.P. Morgan Week,” coinciding with the 43ʳᵈ Annual J.P. Morgan Healthcare Conference in San Francisco, from January 13-16, 2025."

"Oncocyte Corp...today announced the publication of favorable data regarding its DetermaCNI™ assay...For context, copy number instability (CNI) is a scientifically well-known hallmark of cancer. DetermaCNI™ is a patented approach to measuring CNI for the diagnosis and monitoring of cancer."

"Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO™."

P3 | N=278 | NeoTRIPaPDL1 (NCT02620280) | "Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO....As noted above, patients receiving a DetermaIO-positive (IO+) result had a significantly higher pathologic complete response (pCR) rate when treated with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%). DetermaIO-negative (IO-) result patients did not show improved pCR rates with the addition of atezolizumab compared to chemotherapy alone (44.6% vs 49.2%). The interaction test between DetermaIO and the treatment arm was statistically significant (P-value = 0.043). In an unselected patient population, the addition of atezolizumab achieved a numerically higher pCR rate (48.6%) but did not show a significant improvement over the chemotherapy-only arm (44.4%) in patients with TNBC."

"Oncocyte Corporation...announced that five posters of original research are being presented at the Annual Meeting of the American Association for Cancer Research. Four abstracts explore the tumor microenvironment and its potential implications for therapeutic response, leveraging expertise and technology behind DetermaIO. A fifth poster highlights exciting study results applying DetermaCNI, Oncocyte’s proprietary therapeutic monitoring blood test, to metastatic pancreatic cancer."

P2 | N=201 | AtezoTRIBE (NCT03721653) | "Oncocyte Corporation...announces the peer-reviewed publication of the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer (mCRC)....In the overall population (n=122), DetermaIO positive patients achieved better outcomes in terms of progression-free survival from the addition of atezolizumab among mCRC patients than DetermaIO negative patients, regardless of MMR status. A similar trend was observed in the pMMR population (n=110) that does not currently qualify for ICI therapy in mCRC."

"Oncocyte Corporation...announced that DetermaIO has been selected by the SWOG Cancer Research Network, an independent global cancer research community that designs and conducts publicly funded clinical trials, to be used in a prospectively designed biomarker study of breast cancer tissues. These tissues were collected during the S1418 Phase III randomized clinical trial of Keytruda^® (pembrolizumab) in primary triple negative breast cancer (TNBC)."

"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."

P2 | N=119 | IMvigor210 (NCT02951767) | Sponsor: Hoffmann-La Roche | P2 | N=310 | IMvigor210 (NCT02108652) | Sponsor: Hoffmann-La Roche | "Oncocyte Corporation...announces the peer-reviewed publication evaluating the performance of DetermaIO™ in metastatic urothelial (bladder) cancer treated with the immune checkpoint inhibitor (ICI), Tencentriq^® (atezolizumab)....The results of the newly published biomarker study showed that DetermaIO identified 40% of the 348 patients available for DetermaIO biomarker analysis as likely responders, and that they had a median survival of 15.6 months compared to 8.8 months without biomarker stratification. At two years, 41.5% of DetermaIO-positive patients were alive versus 28.6% in the population as a whole....Highlights of the peer-reviewed publication include...DetermaIO outperformed nineteen other genomic signatures and additional existing biomarkers originally selected for testing."

P2 | N=201 | AtezoTRIBE (NCT03721653) | "The ESMO GI oral presentation, titled An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: a translational analysis of the phase II randomized AtezoTRIBE study, highlights how researchers found that within the unstratified cohort of patients from AtezoTRIBE, IOOPT+ tumors more frequently had a high amount of tumor mutational burden and longer PFS. When stratifying by treatment arm, IOOPT+ tumors saw significantly higher PFS for patients who received chemotherapy plus immunotherapy versus those who received chemotherapy alone."

"Oncocyte Corporation...announced that it will host a key opinion leader (KOL) webinar on the role of DetermalO™ and the tumor microenvironment in clinical practice..."