CLN Article

Regulatory Roundup

First Rapid HIV Self-Test Kit Gets Approval in U.K.

BioSure’s HIV self test has earned the CE mark, becoming the first legally approved rapid HIV self-test kit to be sold in the U.K. An estimated 26,000 people in the U.K. are unaware that they have HIV and are unknowingly responsible for the majority of the disease’s transmissions.

The BioSure HIV test uses blood from a finger prick sample to detect the presence of IgM, IgG, and IgA antibodies specific to HIV-1 and 2. It has a demonstrated accuracy of more than 99.7%, correctly identifying 999 of every 1,000 negative samples and 997 of every 1,000 positive samples. The test also meets the CE requirement that untrained users be able to perform the test and read the results with the same level of accuracy as a trained healthcare professional, and delivers a result in 15 minutes. However, the BioSure HIV self test might not diagnose recent HIV infection, as it can take up to 3 months for HIV antibodies to reach a level that is detectable. Other HIV home tests are available in the U.K., but these tests require the user to send samples to a lab to get results.

Patients can order BioSure’s test online, after which it is delivered within one working day in plain packaging, enabling individuals to perform the test discreetly and in private. In line with current guidelines, all positive test results must be confirmed by a healthcare professional, and it is recommended that those in high risk groups test every 3 months.

Verax Biomedical Gets FDA Nod for Expanded Rapid Test for Platelet Contamination

The Food and Drug Administration (FDA) has cleared Verax Biomedical’s expanded Platelet PGD test, a point-of-care immunoassay for the detection of bacterial contamination in platelets intended for transfusion. Bacterial contamination of platelets is the number one infectious risk to transfusion recipients and can lead to serious consequences for patients, including sepsis.

The Verax Platelet PGD test is already used by many major U.S. cancer centers and children’s hospitals to check two types of platelets: aspheresis platelets in plasma (also known as single donor platelets) and whole blood derived platelets. With this new FDA clearance, the Platelet PGD test can now be used to check two additional platelet types: pre-storage pool platelets, and aspheresis platelets in PAS-C additive solution and plasma. This makes the Verax Platelet PGD test the only rapid test on the market cleared to check every commonly distributed platelet type in the U.S.

FDA Authorizes Two Tests for Roche’s cobas 4800 System

Roche has received Food and Drug Administration approval for the cobas KRAS mutation test to aid clinicians in determining a therapeutic path for metastatic colorectal cancer (mCRC) patients, as well as 510(k) clearance for the cobas Cdiff test to detect Clostridium difficile (C. difficile) in stool specimens. Both tests are designed to run on the cobas 4800 system.

Roche’s cobas KRAS mutation test is a real-time PCR assay designed to detect mutations in codons 12 and 13 of the KRAS gene in tumor samples from mCRC patients. It is also intended to identify mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) might be effective if no KRAS mutation is present.

The cobas Cdiff test directly targets the toxin B gene found in toxigenic C. difficile strains in specimens from symptomatic patients. In a clinical trial program conducted at sites throughout the U.S., the test demonstrated improved performance compared to direct and enrichment toxigenic culture, according to Roche.

The cobas 4800 system also can run on one platform mixed batch testing of the cobas Cdiff test alongside testing for methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2. This could give laboratories the ability to run these assays together at least once in a shift rather than once a day.

AITbiotech Dengue Test Granted CE Mark

AITbiotech, a Singapore-based molecular diagnostics manufacturer and genomic service provider, has received the CE mark for its abTES DEN 4 qPCR I kit, a multiplexed real-time PCR test for dengue infection. According to the World Health Organization, the incidence of dengue has risen dramatically around the world in recent decades, and local transmission of the disease in Europe was reported for the first time in France and Croatia in 2010, with an outbreak of more than 2,000 cases occurring in Portugal in 2012.

AITbiotech’s kit can detect and differentiate between dengue virus serotypes 1, 2, 3, and 4 in clinical samples in a single reaction tube, and can be used for population surveillance of the dengue virus. A recent study in the Journal of Clinical Microbiology also demonstrated that the abTES kit is more sensitive and less time-consuming than other molecular methods designed to provide rapid diagnosis of dengue infection.

Cepheid’s Point-of-Care Ebola Test Listed by WHO in Emergency Use Assessment

The World Health Organization (WHO) has assessed and listed Cepheid’s Xpert Ebola test as eligible for procurement to Ebola-affected countries. Xpert Ebola is a molecular diagnostic test for Ebola Zaire virus that delivers results in less than 2 hours. It also runs on the Cepheid GeneXpert system in a self-contained­ cartridge to guard against potential contamination. Since the start of the Ebola outbreak in West Africa at the end of 2013, 26,722 cases and 11,064 deaths had been reported worldwide as of May 2015, the majority of them in Guinea, Liberia, and Sierra Leone. During the height of the epidemic, many health clinics in the affected countries closed because patients were concerned that they were not safe to visit. With this point-of-care test, Cepheid aims to expedite the evaluation of suspected Ebola cases and help routine health services to stay intact during current and future outbreaks by enabling Ebola testing to take place outside of the clinic.