Genetic Technologies Limited (NASDAQ: GENE) stock was trending higher 24.19% to $5.36 in the morning session after the Molecular diagnostics company GENE published the following update on the further progress made on the COVID-19 test of serious disease risk and the expansion of the product line to include a Germline Testing division.
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After including 4,000 more patients’ data, the total COVID-19 positive patient data analyzed exceeds 5,500.A 100% improvement in prediction abilities from age and sex alone1. An analysis of the test indicates that it is well calibrated2. The algorithm’s accuracy and consistency will continue to improve as more datasets are available.
After final validation of the expanded dataset, the Company anticipates the application for regulatory clearance will be submitted via Centers for Medicare and Medicaid Services/Clinical Laboratory Improvement Amendments (CMS/CLIA) by the end of Q1 CY21.
Commercialization opportunities are being discussed in conjunction with regulatory filings and clearances under CLIA regulations.
Additional to the previously announced equipment calibration as well as specialized in house training for the scientific team, the Company has started work on setting up its Germline Testing division with an initial focus on:
- The BRCA test will be offered in conjunction with the GeneType for Breast Cancer program, and
- In conjunction with GeneGene for Colorectal Cancer, Lynch Syndrome testing will be offered.
Furthermore, a report of Genetic Technologies Ltd earnings and activity for the period ended December 31, 2020, is scheduled to be released on Thursday, January 28, 2021.
On Thursday, January 28, 2021, at 11:30 AEDT, the Company will hold an investor webinar to discuss further advances to its diagnostic tests as well as the quarterly update.