Rutgers researchers have created an automated blood drawing and testing device that provides rapid results, potentially improving the workflow in hospitals and other health-related institutions to allow health care practitioners to spend more time treating patients.
A study describing the fully automated device is published online in the journal TECHNOLOGY.
"This device represents the holy grail in blood testing technology," said Martin L. Yarmush, senior author of the study and Paul & Mary Monroe Endowed Chair & Distinguished Professor in the Department of Biomedical Engineering at Rutgers University-New Brunswick. "Integrating miniaturized robotic and microfluidic (lab-on-a-chip) systems, this technology combines the breadth and accuracy of traditional blood drawing and laboratory testing with the speed and convenience of point-of-care testing."
A Rutgers biomedical engineering research team created a device that includes an image-guided robot for drawing blood from veins, a sample-handling module and a centrifuge-based blood analyzer. Their device provides highly accurate results from a white blood cell test, using a blood-like fluid spiked with fluorescent microbeads. The testing used artificial arms with plastic tubes that served as blood vessels. The device could provide rapid test results at bedsides or in ambulances, emergency rooms, clinics and doctors' offices.
Theranos Inc founder Elizabeth Holmes and the embattled blood-testing company's former president were indicted on charges that they engaged in schemes to defraud investors, doctors and patients, the U.S. Justice Department announced on Friday.
The charges against Holmes, 34, and Ramesh “Sunny” Balwani, 53, were announced shortly after the privately held company said that she was stepping down as its chief executive.
Prosecutors said that Holmes and Balwani used advertising and solicitations to encourage doctors and patients to use its blood testing laboratory services despite knowing the company could not produce accurate and reliable results consistently.
"This conspiracy misled doctors and patients about the reliability of medical tests that endangered health and lives," FBI Special Agent in Charge John Bennett said in a statement.
The indictment also alleged that Holmes and Balwani made numerous misrepresentations about Theranos' financial condition and prospects. Balwani, who worked at Theranos from September of 2009 through 2016, had also served as chief operating officer and was a member of the board.
According to the March of Dimes, preterm birth occurs in approximately 10% of U.S. pregnancies. Until recently, cervicovaginal fetal fibronectin (fFN) was the only FDA-approved test for predicting preterm delivery in symptomatic women.
Despite its FDA approval, fFN has limited clinical value. A condition with low prevalence, such as preterm delivery, has a low pre-test probability of occurring, hence a negative test result adds little to the assessment of the patient. Thus, a screening test for a low prevalence condition must demonstrate high positive predictive value (PPV) to be useful. The negative predictive value (NPV) of fFN is 99.5%, meaning a negative result is highly predictive that a woman will NOT deliver soon. However, PPV of fFN is only ~17%, meaning that less than 1 in 5 women with a positive test result will proceed to delivery within 7-14 days. For comparison, the PPV of flipping a coin in this population is 4%. Meta-analyses have supported the lack of utility for fFN.
In April 2018, the FDA approved cervicovaginal placental alpha macroglobulin-1 (PAMG-1), (brand name Parto Sure from QIAGEN) as a test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.
Several recent studies have evaluated PAMG-1 for its ability to predict preterm birth.
Wing, et al. conducted a prospective study of pregnant women from 15 US sites, with signs or symptoms of preterm labor between 24 and 35 weeks of gestation with intact membranes and cervical dilations less than 3 cm (>3 cm generally indicates active labor). They compared the utility of PAMG-1 to fFN. Cervicovaginal PAMG-1 demonstrated similar negative predictive value and improved positive predictive value compared to cervicovaginal fFN.
Similarly, Melchor, et al. conducted a retrospective study of women with preterm contractions presenting to a single maternity hospital in Spain. They compared a one year period during which fFN was used to assess risk of pre-term delivery and a one year period where PAMG-1 was used. Similar to the Melchor study, patients were between 24-34 weeks of gestation with signs or symptoms of preterm labor and had intact membranes and a cervical dilation less than 3 cm.
Both studies show improved positive predictive values for PAMG-1 over fFN. However, both studies reported sensitivities for PAMG-1 of 50%. While this test can certainly be viewed as an improvement over fFN, PAMG-1 will only identify half of the women who will deliver within 7 days. Clearly a better marker to predict pre-term delivery is still needed.