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TEST:
Personalized Cancer Monitoring (PCM™)

Company:
Invitae Corp
Type:
Laboratory Developed Test
Related tests:
Evidence

News

2ms
The combination of patient-specific tumor and HPV sequencing to enable high-sensitivity detection of ctDNA in patients with HPV-associated oropharyngeal carcinoma. (ASCO 2024)
The combined detection of personalized tumor-specific alterations and HPV provides a highly sensitive approach for detecting low disease burden in early stage HPV-associated OPC patients before and during treatment.
Clinical • Circulating tumor DNA
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Personalized Cancer Monitoring (PCM™)
2ms
MRD Assay evaluates Recurrence and response via a tumor Informed Assessment: MARIABreast Observational Trial (ASBrS 2024)
Primary endpoint of this study is to evaluate the correlation between PCM test results at the landmark time point and the patient's 24 month recurrence risk. Secondary endpoints include evaluating the impact on patient outcomes attributable to MRD result-based changes to treatment and other forms of clinical management, correlating between PCM result at baseline time point and patient recurrence risk and outcomes and investigating the lead time of PCM positivity over clinical/imaging based evidence of recurrence
Observational data
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 amplification
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Personalized Cancer Monitoring (PCM™)
6ms
Court grants Natera injunction against Invitae, ArcherDx in use of patented products (Genomeweb)
"The US District Court for the District of Delaware on Friday ordered that ArcherDx and Invitae permanently stop using products containing material patented by Natera, with certain exceptions."
Patent
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Personalized Cancer Monitoring (PCM™)
6ms
Multicenter study of circulating tumor DNA in patients with pancreatic cancer using a personalized panel: ARTEMIS-PC prospective observational trial. (ASCO-GI 2024)
Active enrollment started in December, 2022 and 21 pts with resectable PC and 64 pts with unresectable have been enrolled as of September 2023. Clinical trial information: NCT06043921.
Observational data • Clinical • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation
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Personalized Cancer Monitoring (PCM™)
7ms
First-in-human prospective trial of sonobiopsy in glioblastoma patients using neuronavigation-guided focused ultrasound (SNO 2023)
Transcriptome analysis of sonicated and nonsonicated tumor tissues found that FUS sonication mainly modulated cell physical structure-related genes. ConclusionsThese feasibility and safety data support the continued investigation of sonobiopsy for noninvasive molecular diagnosis of brain diseases.
P1 data • Clinical
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TERT (Telomerase Reverse Transcriptase) • GFAP (Glial Fibrillary Acidic Protein)
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TERT mutation
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Personalized Cancer Monitoring (PCM™)
7ms
Invitae launches enhanced chemistry of MRD test to better serve biopharmaceutical clinical and research partnerships (Invitae Press Release)
"Invitae...announced enhanced chemistry of its Invitae Personalized Cancer Monitoring platform that helps detect circulating tumor DNA (ctDNA) as a biomarker for solid tumor malignancies. ctDNA can provide real-time insights on patient response or disease progression, support patient prognostic stratification and enable early detection of residual disease."
Launch
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Personalized Cancer Monitoring (PCM™)
7ms
MRD Assay evaluates Recurrence and response via a tumor Informed Assessment: MARIA-Breast Observational Trial (SABCS 2023)
Further objectives are to correlate MRD status with pathologic complete response, determine the lead time to detection of recurrence compared to standard of care, and the association of MRD status with overall survival. Active enrollment started in March, 2022.
Observational data
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Personalized Cancer Monitoring (PCM™)
8ms
Tecan sues Qiagen, Invitae, others for patent infringement (Genomeweb)
"Tecan has sued Invitae, ArcherDx, Integrated DNA Technologies, and Qiagen for allegedly infringing on patents related to nucleic acid enrichment and high-throughput sequencing methods...Tecan asserts in the first complaint that its technology underlies what Invitae, ArcherDx, and IDT refer to as their Anchored Multiplex PCR (AMP) target enrichment technology, which is found in Invitae's Personalized Cancer Monitoring (PCM) service and in ArcherDx's LiquidPlex, VariantPlex, and FusionPlex kits."
Patent
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LiquidPlex™ • Personalized Cancer Monitoring (PCM™)
9ms
New trial • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • CA 19-9 (Cancer antigen 19-9)
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Personalized Cancer Monitoring (PCM™)
10ms
Personalized Cancer Monitoring Assay for the Detection of ctDNA in Patients with Solid Tumors. (PubMed, Mol Diagn Ther)
The Invitae Personalized Cancer Monitoring assay, featuring a flexible patient-specific panel design with 18-50 variants, demonstrated high sensitivity and specificity for detecting ctDNA at variant allele frequencies as low as 0.008%. This assay may support patient prognostic stratification, provide real-time data on therapy responses, and enable early detection of residual/recurrent disease.
Journal • Circulating tumor DNA
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Personalized Cancer Monitoring (PCM™)
11ms
Combined patient specific tumor and HPV sequencing enables high sensitivity detection of ctDNA in HPV-associated oropharyngeal carcinoma patients (ESMO 2023)
Two of the three patients with negative baseline MRD-HPV had detectable ctDNA within 1 month from the start of treatment. Conclusions The combination of PCM MRD and HPV ctDNA assays provide a highly sensitive approach for detection of low disease burden in early HPV-associated OPC patients.
Clinical • Circulating tumor DNA
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Personalized Cancer Monitoring (PCM™)
1year
MRD assay to evaluate recurrence and response via a tumor-informed assessment: MARIA-Breast observational trial. (ASCO 2023)
Active enrollment started in March, 2022. Clinical trial information: NCT05219734.
Observational data
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Personalized Cancer Monitoring (PCM™)
1year
New Study Findings Published in Nature Show Circulating Tumor DNA (ctDNA) Can Predict and Detect Cancer Recurrence Earlier In Non-Small Cell Lung Cancer (PRNewswire)
"The research technology used in the study leverages a patient-specific panel developed to identify variants from a patient's own tumor rather than a static gene panel....In this publication, sensitivity and specificity of >99.9% was achieved at 0.008% variant allele frequency (AF) with 60ng cfDNA input and 0.03% variant AF with 10ng cfDNA input using a 50 variant patient-specific panel....Clinical specificity was assessed in 61 patients without evidence of disease in whom ctDNA was not expected to be detectable."
Clinical data
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Personalized Cancer Monitoring (PCM™)
over1year
Invitae's PCM assay for minimal residual disease receives its first commercial coverage (Invitae Press Release)
"Invitae...announced that its Personalized Cancer Monitoring (PCM™) assay, which helps detect minimal residual disease (MRD) in patients, has obtained its first commercial coverage in all solid tumors by Blue Shield of California. The policy, effective as of March 1, 2023, considers the test medically necessary for patients with stage I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression."
Commercial
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Personalized Cancer Monitoring (PCM™)
over1year
Personalized Cancer Monitoring Assay for the Sensitive Detection of MRD in Solid Tumors (AMP 2022)
The use of the PCM assay, which featured ctDNA MRD testing utilizing patient-specific tumor mutation signatures, enabled sensitive detection of MRD in solid tumors with low DNA input. The PCM assay was able to detect the presence of MRD at low allelic fractions, which may enable early detection of MRD and patient relapse.
Personalized Cancer Monitoring (PCM™)
over1year
Personalized Cancer Monitoring (PCM): A novel ctDNA tool to detect molecular residual disease in patients with early-stage breast cancer (SABCS 2022)
PCMTM detected breast cancer relapse with a long lead-time over clinical relapse, and strong association with relapse free survival, an advancement over previously published data with digital PCR MRD detection. Prospective, interventional trials are now required to assess whether treatment on the basis of MRD detection improves outcome, including the TRAK ER Trial (NCT04985266).
Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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Personalized Cancer Monitoring (PCM™)
over1year
A randomised phase II trial of palbociclib and fulvestrant vs standard endocrine therapy in patients with ER positive HER2 negative breast cancer and ctDNA detected molecular relapse during adjuvant endocrine therapy (TRAK-ER) (SABCS 2022)
Standard endocrine therapy (GnRH analogues, aromatase inhibitors and tamoxifen) must have been received for a minimum of 6 months and a maximum of 7 years and be planned to continue for at least another 3 years. Secondary endpoints include relapse free interval, invasive disease free survival, distant recurrence free survival, overall survival and ctDNA clearance. (NCT04985266)
P2 data • Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative
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Personalized Cancer Monitoring (PCM™)
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Ibrance (palbociclib) • tamoxifen • fulvestrant
almost2years
Association of pre-treatment ctDNA with disease recurrence and clinical and translational factors in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy (CheckMate 915) (ESMO 2022)
Methods Post-resection pre-treatment plasma from 1127 pts with stage IIIB-D/IV resected melanoma treated with nivolumab + ipilimumab vs nivolumab in the phase 3 CheckMate 915 study (NCT03068455) was retrospectively evaluated for ctDNA status and level, using a tumor-guided, pt-specific panel of up to 200 variants (Invitae Personalized Cancer MonitoringÔ). Table: 788O RFS probability by pre-treatment ctDNA status in CheckMate 915 treated patients conclusions Pre-treatment ctDNA was associated with increased risk of early recurrence across treatment arms. ctDNA is a useful biomarker for combined analyses predicting outcome for adjuvant melanoma.
Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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Personalized Cancer Monitoring (PCM™)
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Opdivo (nivolumab) • Yervoy (ipilimumab)
2years
Invitae launches full access to its liquid-based personalized cancer monitoring platform to help detect disease earlier (Invitae Press Release)
"Invitae...announced full access to its Personalized Cancer Monitoring (PCM) platform to help detect minimal or molecular residual disease (MRD) in patients with solid tumors. Invitae PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor DNA (ctDNA) in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies."
Launch
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Personalized Cancer Monitoring (PCM™)