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With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.
Novacyt said that the growing demand for its SARS-CoV-2 test, which was launched in late January, has significantly exceeded its expectations.
The company's Linea COVID-19 assay kit is a high-sensitivity real-time, reverse-transcriptase PCR-based assay to detect target sequences of the SARS-CoV-2 Spike gene.
The firms are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3, for Bayer's Vitrakvi cancer treatment.
The paper, which is not peer-reviewed, said that use of the test as a first-step screening tool would require confirmation of more than 80 percent of its results.
The firm's revenues fell to $2.2 million from $3.2 million in the same period the year before, missing the consensus Wall Street estimate of $3.0 million.
The company was able to increase its total revenue and test revenues despite accessioning fewer samples and fewer billable samples during the quarter.
The company will use proceeds from the offering to pay off debt related to other notes and to partially fund a redemption of other notes.
The test is designed to detect the SARS-CoV-2 nucleocapsid gene in nasopharyngeal, oropharyngeal, nasal, and midturbinate nasal swab samples.
Takeda's financial contribution will enable the International Atomic Energy Agency to ramp up its initiative to supply RT-PCR tests to laboratories globally.
Thermo Fisher will seek Emergency Use Authorization from the US FDA and international regulatory authorizations for the test over the next few weeks.
BioReference will provide administrative services, laboratory equipment, supplies, and procurement processes for the hospital.
The test is designed to detect the E and RdRp genes of SARS-CoV-2 in various respiratory specimens including nasopharyngeal swabs and nasal aspirates.
The IMI announced the call in February with an initial budget of €45 million but raised the total funding amount to €72 million.
The May 8 settlement resolves all claims and counterclaims relating to noninvasive prenatal testing and pre-implantation genetic screening and diagnosis.
The firm withdrew its 2020 revenue guidance and missed Wall Street estimates for both revenues and earnings.
The expansion increases the number of PCR instruments and types of reagents and consumables labs can use to run the Applied Biosystems TaqPath COVID-19 Combo Kit.
The company recently received Medicare coverage for the DetermaRx assay that it brought to market through its acquisition of Razor Genomics late last year.
The cancer test developer will use the funding to commercialize its enrichment-based NGS panels. An IVD test also got CE marked.
Under a strategic partnership, workflows will be developed for Proteomedix's Proclarix prostate cancer test on Dynex's automated ELISA platforms.
The PCR-based test received EUA for use on the Alinity m platform after receiving authorization in March on the firm's m2000 RealTime System.
The company said that it expects to use the funds for general corporate purposes including the repayment of existing senior notes due 2021.
Noridian is also developing a generic policy for donor-derived cfDNA tests that will include several commercially available tests, Natera said.
The test is designed to detect immunoglobulin A, immunoglobulin M, and immunoglobulin G antibodies against SARS-CoV-2 in blood samples.