Laguna Hills, California-based Prelude Corporation (PreludeDx) recently announced that the Centers for Medicare & Medicaid Services (CMS) gave its DCISionRT test Advanced Diagnostic Laboratory Test (ADLT) status, a category reserved for innovative products with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests, among other criteria.
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit, according to PreludeDx. The test combines protein expression from seven biomarkers and four clinicopathologic factors and uses a nonlinear algorithm to account for multiple interactions between individual factors to better interpret this complex biological information.
DCISionRT’s reporting software provides a woman's recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. This new information may help patients and their physicians make more informed treatment decisions, the company said.
COLLECTION DEVICE FOR SARS-COV-2 TESTING SAMPLES RECEIVES FDA CLEARANCE
The FDA has granted 510(k) clearance for Pleasanton, California-based Mawi DNA’s iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) device, the company announced.
The device is intended for stabilization and inactivation of human upper respiratory and saliva specimens suspected of containing SARS-CoV-2. It can be used for collection, transport, and storage at ambient temperature.
The device also enables surveillance testing of SARS-CoV-2 and its variants in any clinical setting. Currently used for population-scale sampling to mitigate the impact of the virus’s spread, iSWAB-RC-EL enables hospital and clinical lab personnel to skip the RNA extraction step in the PCR testing protocol. The biosampling device also offers a nontoxic formulation that inactivates viruses to decrease potential spread and exposure, especially among lab personnel processing samples.
FDA CLEARS TEST FOR CYP2C19 VARIATIONS
Ottawa, Canada-based Genomadix recently announced it has received FDA 510(k) clearance for it its Genomadix Cube CYP2C19 System (Cube CYP2C19 Test), an automated sample-to-result PCR test.
The Cube CYP2C19 Test helps clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. The Cube CYP2C19 Test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a noninvasive buccal swab in 1 hour.
Company officials said the Genomadix Cube CYP2C19 System would help physicians to make informed decisions on selecting drugs for precision medicine, such as antiplatelet therapy in stroke and for cardiology patients.
The test runs on the Genomadix Cube, a platform capable of performing tests for genetic, infectious disease, and environmental targets on a sample-to-result platform. The system’s portable size, ease of use, and on-demand processing capability enables users to generate time-critical results in a near-patient setting, according to the company.
BREAST CANCER TEST GETS CE MARK
Calgary, Alberta-based Syantra recently announced it obtained the CE mark for its Syantra DX Breast Cancer Test, a blood test that detects an active breast cancer signature.
The CE mark allows Syantra to market its test in the European Union and other countries that recognize the designation.
The test evaluates gene expression patterns of 12 unique biomarkers through a quantitative PCR process that uses proprietary software including machine learning-derived algorithms.
Company officials said the test may help improve detection in high-risk women, especially those with genetic predisposition to breast cancer, dense breasts, or diverse ethnic backgrounds. For these women, standard screening mammogram may be inadequate.
COVID-19 TEST GETS EMERGENCY USE AUTHORIZATION (EUA)
The FDA recently granted EUA to the MedArbor Diagnostics SARS-CoV-2 Assay.
The test is a real-time PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, and nasal aspirate specimens from individuals suspected of COVID-19 by their healthcare provider, according to an FDA fact sheet. The test should be ordered by healthcare providers, the fact sheet says.
The test’s performance, based on evaluation of a limited number of clinical specimens, has not been established in all circulating variants. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARSCoV-2 and their prevalence, which change over time, the FDA adds.
LUNG CANCER PCR COMPANION DIAGNOSTIC APPROVED IN JAPAN
China-based Riken Genesis Co., Ltd. (AmoyDx), and Precision Medicine Asia Co., Ltd. (PREMIA) recently announced Japanese Ministry of Health, Labor, and Welfare (MHLW) approval of their AmoyD® Pan Lung Cancer PCR Panel (AmoyDx PLC Panel) as a companion diagnostic for RET fusion-positive non-small cell lung cancer (NSCLC), for selpercatinib capsules 40 mg and 80 mg.
The AmoyDx PLC Panel is based on PCR technology. It simultaneously can evaluate the presence of activation alterations in 11 driver genes when all genes on the panel are approved as companion diagnostics.
The AmoyDx PLC Panel has received approval for the identification of activating alterations in seven driver genes for 12 associated targeted therapies in NSCLC.
With its high sensitivity and short turnaround time, the AmoyDx PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients, the companies said.
COVID-19 AND FLU COMBO TEST APPROVED IN AUSTRALIA
Emeryville, California-based Lucira Health, Inc. recently announced that its Lucira COVID-19 & Flu Home Test has been included in the Australian Register of Therapeutic Goods (ARTG) for use by healthcare professionals in a point-of-care setting, during the southern hemisphere’s flu season.
The Lucira COVID-19 & Flu Home Test is a molecular test that has demonstrated similar performance for SARS-CoV-2 and influenza compared to highly sensitive lab-based PCR tests in clinical trials. The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab.
Company officials said they believe that the combination test’s speed and accuracy will help Australian patients access treatment earlier in the course of the infection.