LabCorp and PerkinElmer have released two dramatically different tests that are both intended to address challenges in diagnosing pediatric patients with potentially life-threatening conditions. The North Carolina-based LabCorp had released a test that is expected to provide a more accurate diagnosis of the Enterovirus D68, which is commonly known as EV-D68. The test, which was released last month, was introduced after an outbreak of EV-D68 in the U.S. in 2014 that was far larger than normal. The outbreak season for the virus is in the summer and autumn months. The U.S. Centers for Disease Control and Prevention reported that the numbers of persons infected with EV-D68 last year exceeded 1,100 – “far higher” than any year going back at least to 1987, the agency said. A typical year includes just a handful of reported cases. As a result, the agency issued treatment protocols for EV-D68 patients. Although adults can be infected with EV-D68 and have so few symptoms they may not be aware they are ill, the virus can be brutal on children and teenagers, particularly those with existing respiratory conditions such as asthma or wheezing, and may require hospitalization. At least 13 deaths last year were linked to the […]
LabCorp and PerkinElmer have released two dramatically different tests that are both intended to address challenges in diagnosing pediatric patients with potentially life-threatening conditions.
The North Carolina-based LabCorp had released a test that is expected to provide a more accurate diagnosis of the Enterovirus D68, which is commonly known as EV-D68. The test, which was released last month, was introduced after an outbreak of EV-D68 in the U.S. in 2014 that was far larger than normal. The outbreak season for the virus is in the summer and autumn months.
The U.S. Centers for Disease Control and Prevention reported that the numbers of persons infected with EV-D68 last year exceeded 1,100 - "far higher" than any year going back at least to 1987, the agency said. A typical year includes just a handful of reported cases. As a result, the agency issued treatment protocols for EV-D68 patients.
Although adults can be infected with EV-D68 and have so few symptoms they may not be aware they are ill, the virus can be brutal on children and teenagers, particularly those with existing respiratory conditions such as asthma or wheezing, and may require hospitalization. At least 13 deaths last year were linked to the virus, the CDC reported.
LabCorp's assay is known as a "reflex" test in that it will be conducted in multiple stages depending on the initial findings. The test initially determines the presence or absence of enteroviral RNA in a respiratory sample. If that's positive, it will then "reflex" to an EV-D68-specific PCR test to determine the virus' specific strain.
"Understanding the underlying cause of this severe illness allows the clinician to manage symptoms appropriately through protocols like those issued by (the Centers for Disease Control and Prevention), which may also help reduce further transmission of the virus," said Mark Brecher, M.D., LabCorp's chief medical officer.
PerkinElmer released another assay that tests for another potentially deadly condition in children: Severe Combined Immunodeficiency (SCID), or what is popularly known as "bubble boy disease." The condition occurs in about one in every 58,000 births, and essentially brings the newborn into the world without an active immune system. The Massachusetts-based PerkinElmer had previously sold the test, known as EnLite, in Europe, but recently received regulatory approval to sell it in both the United States and Canada.
Most undiagnosed sufferers of SCID would rapidly succumb to infections not noticed in an infant with a normal immune system. In the past, the few survivors of SCID were confined to carefully controlled sterile environments. More recently, the condition can be treated with the transplantation of stem cells from family members or other donors, although a rapid diagnosis of the condition tends to lead to better outcomes.
PerkinElmer officials said the test focuses on a particular DNA structure that is the primary marker for SCID. The test can be used in conjunction with other typical screenings of newborns.
"Earlier detection and diagnosis of SCID can result in cost-savings and benefits, due to the fact that earlier-diagnosed infants with SCID require less-intensive clinical care for a shorter period of time," said Fred Lorey, a PerkinElmer consultant specializing in newborn screening services.
Neither LabCorp nor PerkinElmer released prices for the new tests.
Takeaway: LabCorp and PerkinElmer have introduced esoteric tests that can better improve care for pediatric patients with specific conditions.
