The Observatory and Fast Facts

March 21, 2019
Molecular diagnostics

BD complete molecular portfolio for gastrointestinal infection (GI) with new viral panel. BD (Becton, Dickinson and Company) announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of its BD MAX enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The company now offers a broad suite of solutions for the detection of intestinal conditions of bacterial, viral, and parasitic origin, in clinically relevant, targeted panels.

Acute viral gastroenteritis can be contracted by virtually any patient and spread within close community settings such as daycare centers, nursing facilities, and cruise ships. Norovirus is the most common viral cause and accounts for 19 to 21 million cases of diarrheal illness annually in the United States, and 50 percent of all foodborne diarrheal outbreaks. Other viral causes include rotavirus, adenovirus, astrovirus, and sapovirus to varying degrees of prevalence. Diagnosing the underlying cause of diarrhea can play a critical role in patient management to isolate patients at risk of spreading infectious diarrhea to others and rule out other causes of infection in children, the elderly, or immunocompromised patients.

The BD MAX enteric suite of molecular tests for the detection of gastrointestinal bacteria, parasitic, or viral pathogens enable clinicians to perform targeted testing for patients based upon their symptoms and health history or exposure. This testing approach is supported by the Infectious Diseases Society of America (IDSA) guidelines. The BD MAX enteric viral panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms in all care settings and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

The enteric panels run on the BD MAX molecular system and can return results in less than 3.5 hours, dramatically shortening time to results over traditional test methods. This shortened time to results allows clinicians to more quickly understand the cause of the patient’s illness.

Pharmacogenomic testing

Translational Software partners with Allscripts to provide pharmacogenomic testing for associates. Translational Software recently announced its partnership with Allscripts Healthcare Solutions, a practice management and electronic health record (EHR) technology company. The collaboration will provide free pharmacogenomic testing to all U.S.-based Allscripts associates.

When associates undergo a lengthy process of trial-and-error prescribing, employers suffer the cost as well. Pharmacogenomic testing can help provide personalized guidance to individuals on medication efficacy and dosage, which results in improving medication adherence, increasing worker productivity, and reducing work absenteeism. With studies demonstrating the cost-effectiveness of pharmacogenomic-informed treatment, Allscripts recognized the value of associate wellness, satisfaction, and engagement in their overall health.

Translational Software has partnered with the telehealth company PWN Health and Allscripts subsidiary 2bPrecise to automate a new end-to-end pharmacogenomic healthcare benefit program. The new program is run on a portal built by Translational Software, where associates can place an order. PWN approves the order and sends out a testing kit. Once the kit is sent back by the associate, it is then routed to a testing laboratory in the Translational Software network selected by Allscripts. The laboratory performs the test and sends the interpreted results back to the portal, where they are accessible by the associate. If an associate is interested in counseling on how to interpret their results, PWN offers telehealth sessions with a healthcare professional.

Translational Software is building an ecosystem of laboratories, health professionals, independent software vendors, and employers to coordinate and deliver comprehensive, personalized care. Translational Software can help employers understand and deliver an evidence-based pharmacogenomic benefit to their associates through custom programs like this one.

Breast cancer

Older biologic age linked to elevated breast cancer risk. Biologic age, a DNA-based estimate of a person’s age, is associated with future development of breast cancer, according to scientists at the National Institutes of Health (NIH). Biologic age was determined by measuring DNA methylation, a chemical modification to DNA that is part of the normal aging process. The study showed for every five years a woman’s biologic age was older than her chronologic or actual age, known as age acceleration, she had a 15 percent increase in her chance of developing breast cancer. The study was published online in the Journal of the National Cancer Institute.

Scientists from the National Institute of Environmental Health Sciences (NIEHS), part of NIH, speculate that biologic age may be tied to environmental exposures. If so, it may be a useful indicator of disease risk. They used three different measures, called epigenetic clocks, to estimate biologic age. These clocks measure methylation found at specific locations in DNA. Researchers use these clocks to estimate biologic age, which can then be compared to chronologic age.

The researchers used DNA from blood samples provided by women enrolled in the NIEHS-led Sister Study, a group of more than 50,000 women in the U.S. and Puerto Rico. The study was specifically designed to identify environmental and genetic risk factors for breast cancer. The research team measured methylation in a subset of 2,764 women, all of whom were cancer-free at the time of blood collection.

Lead author Jacob Kresovich, PhD, suggests that using DNA methylation to measure biologic age may help scientists better understand who is at risk for developing cancer and other age-related diseases. This research is an example of epigenetics, a field that studies how biochemical processes turn individual genes on or off, without affecting the DNA sequence.


Grifols receives FDA approval for donor screening assay. Grifols, a producer of plasma-derived medicines and a developer of diagnostic solutions, announced that the FDA approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA from four Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

The assay runs on the Procleix Panther system—a fully automated platform utilizing Nucleic Acid Testing (NAT) for blood screening. The FDA approval recognizes a successful multi-center clinical trial conducted under an Investigational New Drug (IND) study at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center (an affiliate of the New York Blood Center, Inc.), in select areas of the U.S.

Babesia is a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected donors.

According to the Centers for Disease Control and Prevention (CDC), the highest numbers of Babesia infections occurred in Massachusetts, New York, Connecticut, Rhode Island, New Jersey, Maine, New Hampshire, Wisconsin, and Minnesota.


Incidents of vocal cord cancer are on the rise in children, teens and young adults under 30. Research has shown vocal cord cancer can be viral (HPV), and results of a brand-new study shows this link between HPV and cancer may growing in children, teens and young adults under 30 years of age.

This research investigation was performed by vocal surgeon, Dr. Steven Zeitels at Harvard Medical School (HMS) and Massachusetts General Hospital (MGH), with the strategic support of the patient non-profit Voice Health Institute (VHI).

This is the first institutionally-based investigation to demonstrate that vocal cord cancer is undergoing a dramatic epidemiological change showing young patients are now being diagnosed who do not have a history of smoking.

The general public is not aware of this epidemiologic transformation and remarkably, despite this trend, the American Academy of Otolaryngology Head and Neck Surgery still cites smoking is the etiology for 95 percent of patients with vocal cord cancer.

According to the study, tobacco-induced vocal cord cancer takes years/decades to develop. However, HPV presence speeds up the development of vocal cord cancer. The young adults who do smoke haven’t been using tobacco long enough for the disease to develop.

Data from the study includes (1) Throat cancer was not encountered in patients 30 years or younger between 1990 and 2004; (2) 11 cases were identified between 2004 and 2018; of those eight had never smoked; and three of those 11 had less than a three-year smoking history (not long enough for the disease to develop); and (3) 10 of the 11 patients tested positive for HR-HPV.