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In Brief This Week: DiaSorin Molecular, Fulgent Genetics, Biocept, Yourgene, and More

NEW YORK – DiaSorin Molecular said this week that the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority has provided funding for the firm's validation and submission of the Simplexa COVID-19 Direct Kit for 510(k) clearance from the US Food and Drug Administration. The funding, whose amount was not disclosed, will also go toward expanding the manufacturing capacity for the kits' production, the Cypress, California-based company said. The kit detects the presence of RNA of SARS-CoV-2 and has been available in countries that accept CE marking, and in the US through Emergency Use Authorization from the FDA since March. The test is for use with DiaSorin Molecular's Liaison MDX instruments and provides results in about one hour. The company, a subsidiary of DiaSorin, noted there are more than 1,200 such platforms installed worldwide.


Fulgent Genetics said this week it has extended its partnership with the New York City Department of Education and NYC Health + Hospitals to test for COVID-19 through the remainder of the 2021 school year. Financial details of the partnership were not disclosed. Fulgent will provide daily COVID-19 testing for students and employees at many K-12 schools in New York City, leveraging the Temple City, California-based company's RT-PCR test, which received Emergency Use Authorization from the US Food and Drug Administration in May. Test results will be available to individuals generally within 24 hours from the time Fulgent receives and accepts a patient's specimen, it said. The test uses nasal swab samples and takes about one minute for a student to complete. The firm said it has processed "many thousands" of student samples.


Biocept this week announced that it has entered into laboratory services agreements with two San Diego-based independent physician associations that provide in-network access to the molecular diagnostic firm's Target Selector liquid biopsy oncology assays and services. The physician associations serve more than 70,000 covered lives in Southern California. 

The Target Selector platform captures and analyzes tumor-associated molecular markers in circulating tumor cells and circulating tumor DNA.

Biocept said it anticipates entering into additional services agreements with value-based providers.


Yourgene said last week that Yourgene Genomic Services has been added to the UK government's list of approved COVID-19 private testing providers, both for general coronavirus testing and for the "test to release" program for international travelers arriving in the UK. The company also said that it has conducted a simulation study into the new coronavirus strain circulating in the UK, which suggests that the performance of its test will remain unaffected.


Applied DNA Sciences said this week that its wholly owned subsidiary, Applied DNA Clinical Laboratories, has entered into a reseller and sales referral partnership with Cleared4, a provider of return-to-work health safety solutions. ADCL will be able to resell subscriptions to Cleared4's platform as part of ADCL's SafeCircle pooled COVID-19 surveillance testing program, while Cleared4 will be able to refer its clients interested in pooled COVID-19 surveillance testing to ADCL. The partners have integrated SafeCircle lab testing operations with Cleared4's platform as an option for current and prospective ADCL clients. Cleared4 has also integrated ADCL's pooled surveillance testing product into its HIPAA-compliant platform, and it can offer SafeCircle to its clients. Financial and other terms of the deal were not disclosed.


DermTech said this week that Geisinger Health System has issued a positive medical benefit policy for its commercial and Medicare business segment for the firm’s Pigmented Lesion Assay. The policy closely mirrors the final local coverage determination by Medicare Administrative Contractor Palmetto GBA MolDx, the La Jolla, California-based firm said. According to DermTech, Geisinger has determined that gene expression profiling for cutaneous melanoma using the assay is medically necessary if the lesion meets at least one ABCDE (asymmetry, border, color, diameter, and evolving) criteria; the primary melanocytic skin lesions are between 5 mm and 19 mm; the lesion skin is intact; the lesion does not contain a scar or has been previously biopsied; the lesion is not located in areas of psoriasis, eczema, or similar skin conditions; the lesion has not been diagnosed as melanoma, or is highly suspected by the treating clinician that it is more likely than not to be melanoma; and the lesion is in areas other than the palms of hands, soles of feet, nails, mucous membranes, and areas covered by hair that cannot be trimmed.


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.