The ID Pipeline: New Dolutegravir Indication, Latest COVID-19 EUAs

The US Food and Drug Administration (FDA) is a key global regulatory authority. Here are updates from this week on the FDA pipeline, particularly concerning infectious diseases:

New Indication: FDA Approves Dolutegravir Tablets for Pediatric HIV

Date of Publication: June 12, 2020

The US Food and Drug Administration (FDA) has approved dolutegravir tablets (Tivicay) and tablets for suspension (Tivicay PD) for the treatment of HIV-1 infection in pediatric patients.

The indication, granted to ViiV Healthcare, allows for the administration of dolutegravir to patients as young as 4 weeks old, and as light as 3 kg (6.61 lbs) in combination with other antiretroviral therapy.

There was more than 2200 children younger than 13 years old in the US living with HIV at the end of 2016, according to the US Centers for Disease Control and Prevention (CDC). Another 99 new HIV-1 infections were diagnosed in this age group in the next year.

Patients eligible for the therapy have not been treated for their HIV—or at least not with an integrase strand transferase inhibitor (INSTI) class drug.

The efficacy and safety of dolutegravir in pediatric patients was evidenced by a trial including 75 infected infants, children, and adolescents aged 4 weeks to 18 years old. Mean patient age was 27 months. Both patients and investigators were informed of which therapy they were being administered in the trial.

Read the full story.

FDA Issues Emergency Use Authorization for COVIDSeq Diagnostic

Date of Publication: June 10, 2020

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Illumina Inc’s COVIDSeq Test, according to a statement the firm released.

COVIDSeq is a qualitative test for the detection of SARS-CoV-2 RNA from nasopharyngeal swabs or oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage specimens.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product,” the FDA’s authorization letter read.

SARS-CoV-2 nucleic acid is detectable in respiratory samples during the acute phase of infection. Clinical assessment and review of other diagnostic information is necessary to comprehensively determine the probability of viral acquisition. Positive results also do not rule out co-infection with other viruses.

Read the full story.

FDA Authorizes Real-Time PCR Assay for COVID-19

Date of Publication: June 10, 2020

The US Food and Drug Administration has granted Emergency Use Authorization (EUA) to ChromaCode’s HDPCR SARS-CoV-2 Real-Time PCR Assay.

The assay authorization grants the company utility for the device’s purpose of detecting SARS-CoV-2 from nasopharyngeal swab specimens from patients suspected by their healthcare providers of having contracted coronavirus 2019 (COVID-19).

ChromaCode now intends to use its own multiplexing technology to help launch a COVID-19 assay later this year. The assay would combine multiple respiratory viruses into a single test in anticipation of the upcoming flu season.

The company’s assay platform runs on standard qPCR instruments with no required hardware/software changes, and provides a US Centers for Disease Control and Prevention (CDC) assay consolidated into a single reaction well—allowing labs to run 1000-plus samples per qPCR instrument over a 24/7 testing period.

"Customers continue to experience extraordinary increases in testing volume; our ability to enable labs to process thousands of samples in one day using existing laboratory equipment means they can rapidly scale testing to meet high demands," Greg Gosch, ChromaCode's Co-founder, president and chief executive officer, said in a statement. "With testing volumes continuing to grow, it is important that institutions have continued access to the inventory they need, so they don't experience the disruption of moving to a different test.”

As such, the company is guaranteeing ongoing supply for customers who sign an agreement, Gosch said.

Read the full story.

FDA Emergency Authorization: IgG/IgM Rapid Coronavirus Diagnostic

Date of Publication: June 09, 2020

Premier Biotech released a statement revealing that the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to its SARS-CoV-2 IgG and IgM rapid diagnostic.

The test uses whole blood, plasma, or serum. The testing kit is intended to produce reliable results within 10 minutes.

"The FDA's decision to grant Biotest's product EUA is great news for communities across the U.S. that continue to struggle to access adequate COVID-19 testing, which healthcare experts agree is essential to successful recovery from the COVID-19 crisis," said Premier Biotech CEO Todd Bailey in the announcement release.

False negatives and variable reliability plagued earlier tests across the diagnostics industry, but Premier claimed that the test met rigorous testing standards. Premier Biotech attracted the skepticism of a U.S. House subcommittee over concerns its tests are not as accurate as presented.

Premier has defended its previous tests, and intends to release more information on accuracy as it emerges.

"As the grant of EUA confirms, the National Cancer Institute has verified this product exceeds the 95% specificity and 90% sensitivity standards set by the FDA. Undoubtedly, this product is in clear alignment with Premier Biotech's rigorous compliance standards and commitment to distributing high-quality testing solutions. We will continue to follow the regulatory guidelines closely as we distribute the product for emergency use to authorized laboratories nationwide.”

Read the full story.

Related Stories:

• Dealing With False Negatives

The authors of a new commentary published in Mayo Clinic Proceedings explained that while positive results from certain tests can be very helpful, negative COVID-19 diagnostic results may lead to a false sense of security.

• FDA Expands COVID-19 At-Home Test Collection Authorization to Saliva Samples

The US Food and Drug Administration expanded the existing Emergency Use Authorization (EUA) for the Rutgers Clinical Genomics Laboratory to now include the at-home collection of saliva samples for COVID-19 testing.

The extension of the EUA, originally granted last week, indicates the Spectrum Solutions SDNA-1000 saliva collection can be used for self-collection at home. This is the first and currently only FDA authorization of at-home saliva collection for physician-prescribed COVID-19 testing.

• Recap: 5 COVID-19 Related FDA Authorizations in May 2020

A review of 5 COVID-19 related FDA authorizations from the first 10 days of May.

(Interview) Rodney E. Rhode, PhD: Do We Have Enough Trained Laboratory Specialists for Mass Coronavirus Testing?