Its low cost may advance liquid biopsy cancer testing used by anatomic pathologists and improve outcomes by speeding time to diagnosis and treatment
Researchers in Japan say they have created a circulating tumor cell (CTC) detection solution that is inexpensive and easy to run. Such a device would be of huge interest to investors and companies wishing to develop clinical laboratory tests that use circulating tumor cells in the blood to identify patients with cancer.
In a proof-of-concept study, researchers at Kumamoto University (KU) in Japan have developed and tested a microfilter device they claim can separate and capture CTCs in blood without large equipment, a KU news release reported.
According to Medgadget, the device is an “inexpensive, convenient, and highly sensitive filter that can successfully work in samples containing as few as five tumor cells in one milliliter of blood and does not require expensive equipment or reagents, unlike certain pre-existing cell capture technologies.”
This Technology Could Give Pathologists a Less-Invasive Cancer Test
As medical laboratory scientists and anatomic pathologists know, a CTC test is less invasive than tissue biopsy, which benefits patients. Furthermore, such a CTC test may enable earlier detection of cancer and start of treatment improving odds for success.
Still, there are many pitfalls to overcome when the challenge is to detect cancer cells in a milliliter (about .03 fluid ounce) of blood. As Medgadget put it, “A needle in a haystack doesn’t even come close.”
“Cancer cell count in the blood of cancer patients is extremely low. If these cells are easily detectable, cancer diagnosis may be possible by simply using a blood test, thus reducing patient burden,” the researchers wrote in their paper.
“This work demonstrates that our microfilter device can accurately detect trace amounts of cancer cells in blood,” said study leader Yuta Nakashima, PhD (above), Associate Professor, Department of Mechanical System Engineering at Kumamoto University, in the news release. “We expect it will be adopted for cancer diagnosis and treatment, including for early diagnosis of cancers that cannot be detected by imaging like CT and PET scans, post-operative follow-up, recurrence monitoring, and tailor-made treatments. In the future, we plan to use blood samples donated by cancer patients to verify the practical and clinical application of the method,” he added. Were it to become available, such a CTC test would be a boon for clinical laboratories and anatomic pathologists engaged in cancer diagnostics and treatment. (Photo copyright: Kumamoto University.)
How Does the CTC Filter Device Work?
The KU scientists created a palm-size “cancer detection device using a microfilter and nucleic acid aptamer,” the paper said, adding:
It includes slits to enable a deformation with force of blood pumping through the device.
As blood flows over the microfilter, cancer cells bind to the nucleic acid aptamer.
Force of blood flow opens microfilter slits, pushing away the healthy cells.
Cancer cells are left on the microfilter.
To test the microfilter the researchers used one milliliter of blood that was “spiked with cancer cells,” according to the paper. Findings include:
Detection of five CTCs in one milliliter of blood.
Blood cell removal rate of 98% suggested “no blood cells were absorbed by the microfilter,” the news release said.
The method “showed higher accuracy than the CellSearch System,” the Talanta paper noted.
The KU research team compared their microfluidic device to CellSearch, an FDA-cleared system for detecting CTCs from a blood sample.
CellSearch enables “identification, isolation, and enumeration of CTCs of epithelial origin,” according to Menarini Silicon Biosystems of Castel Maggiore, Italy. It works from a blood sample of 7.5 millimeters with “high level of sensitivity and specificity,” notes the company’s website.
According to Menarini, labs offering CellSearch CTC testing include:
The UK scientists admit that their research needs further study. Nakashima indicated he plans to test blood samples donated by cancer patients in subsequent device trials.
“Although great progress has been made, there is a long way to go before CTC-based liquid biopsy is widely used as a routine test in clinical application,” the authors of that study noted.
Nevertheless, even with more to do, liquid biopsy testing has come a long way, as multiple Dark Daily eBriefs reported over the years.
If the KU scientists succeed in bringing to market a microfilter that can reduce the cost of CTC detection by clinical laboratories while also improving cancer diagnostics, that will have a huge impact on cancer patients and is worthy of clinical laboratory leaders’ attention.
Clinical laboratory leaders aiming for patient-centered care and precision medicine outcomes need to acknowledge that patients do not want to be in hospitals or travel to physician offices and patient care centers for blood tests. It can be inconvenient, sometimes costly, and often painful.
That’s why disease management methods such as remote patient monitoring are appealing to many people. It’s a big market estimated to reach $1 billion by 2020, according to a Transparency MarketResearch Report. The study also associated popularity of devices such as heart rate and respiratory rate monitors with economic pressures of unnecessary hospital readmissions.
But can remote patient monitoring be used for more than to check heart rates, monitor blood glucose, and track activity levels? Could such technology be effectively leveraged by medical laboratories for remote blood sampling?
Microsampling versus Dried Blood Collecting
Remote patient monitoring must be able to address a large number of diseases and chronic health conditions for it to continue to expand and gain acceptance as a viable way to care for patients in different settings outside of hospitals. However, as most clinical pathologists and laboratory scientists know, clinical laboratory testing has an essential role in patient monitoring. Thus, there is the need for a way to collect blood and other relevant samples from patients in these remote settings.
One promising approach is the development of new microsampling technology that can overcome past obstacles of dried blood collection. Furthermore, microsampling-enabled devices can make it possible for medical laboratories to reach out to the homebound to secure accurate and volumetrically appropriate samples in a cost-effective manner.
“One well-established fact in today’s healthcare system is that an ever-greater proportion of patients want clinical care that is less invasive and less intrusive,” noted Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “Patients want to take more control over their treatment and be more effective at maintaining the stability of their chronic conditions, and often are happier than those who need to travel to have chronic conditions monitored. To meet this need there has been significant innovation, particularly in the area of remote blood sampling using microsampling technology.”
For decades, medical laboratories have tried various methods for acquiring and transporting blood samples from remote locations. One such non-invasive alternative to venipuncture is called dried blood spot (DBS) collecting. It involves placing a fingerprick of blood on filter paper and allowing it to dry prior to transport to the lab.
But DBS collected bio samples often do not contain enough hematocrit (volume percentage of red blood cells) for laboratories and clinical pathologists to provide accurate reports and interpretations. Reported reasons DBS cards have not penetrated a wide market include:
Hematocrit bias or effect;
Costly card punching and automation equipment; and,
Possible disruption to existing lab workflows.
Microsampling Technology Enables Collection of Appropriate Samples
Microsampling has to have the capability to enable labs to deliver quality results from reliable blood samples. This remote sampling technology makes it possible for phlebotomists to offer a comfortable collection alternative for homebound patients and rural residents. It also can be useful for physicians stationed in remote areas. Patients themselves can even collect their own blood samples.
Volumetric Absorptive Microsampling (VAMS) technology enables accurate samples of blood or other fluids from amounts as small as 10, 20, or 30 microliters, according to Neoteryx, LLC, of Torrance, Calif., the developer of VAMS. The technology is integrated into the company’s Mitra microsampler blood collection devices (shown above) in formats for patient use and for medical laboratory microsample accessioning and extraction. Click here to watch a video on the Mitra Microsampler Specimen Collection Device. (Photo copyright: Neoteryx.)
One company developing these types of products is Neoteryx, LLC, of Torrance, Calif. It develops, manufactures, and distributes microsampling products. Patients with the company’s Mitra device use a lancet to puncture their skin and draw a small amount of blood, collect it on the device’s absorptive tip, and then mail the samples to a blood lab for testing (Neoteryx does not perform testing).
“Technologies such VAMS are driving [precision medicine] in an extremely cost-effective manner, while only requiring minimal patient effort. Patients are taking a more active role in their healthcare journeys, and at-home sampling is supporting this shift,” stated Fasha Mahjoor, Chief Executive Officer, Neoteryx, in a blog post. (Photo copyright: Neoteryx.)
Advantages of Microsampling
Patient satisfaction survey data collected by Neoteryx suggest patients are comfortable with their role in blood collection:
70% are comfortable or very comfortable with the process;
86% say it is easy or very easy to use the Mitra device;
92% report it is easy to capture blood on the device’s tip;
55% of Mitra device users are likely or very likely to choose microsampling over traditional venipuncture; and,
93% noted they are likely or very likely to choose the device for child care.
A list of published studies describes certain advantages of VAMS technology that have implications for medical laboratories and clinical pathologists:
Microsampling has benefits and implications for therapeutic drug monitoring, infectious disease research, and remote specimen collection;
Dried blood microsamples from fingerstick can generate reliable data “correlating” to traditional blood collection processes;
Bioanalytical data collected with the Mitra device are accurate and dependable; and,
In a study for a panel of anti-epileptic drugs, VAMS led to optimized extraction efficiency above 86%, which means there was no hematocrit bias.
Learn More by Requesting the Dark Daily Microsampling White Paper
Rise of patient-centered care and remote patient monitoring;
Dried blood collection over the years and the hematocrit effect;
A look at microsampling and how it takes blood collection out of the clinic;
How Volumetric Absorptive Microsampling (VAMS) technology works;
Patient satisfaction data;
Research about microsampling including extensive graphics;
Launching new VAMS technology; and,
Frequently asked questions.
Innovative medical laboratory leaders who want to increase their understanding of how microsampling technology and remote patient monitoring relates to the goal of becoming a patient-centered lab are encouraged to request a copy of the white paper. It can be downloaded at no cost by clicking here, or placing https://www.darkdaily.com/how-to-create-a-patient-centered-lab-with-breakthrough-blood-collection-technology-9-2018/ into your browser.
Honors highlight concern among public and press over potential harm to patients of the medical laboratory industry and the need for more transparency in the quality of care delivered by pathologists and lab scientists
John Carreyrou, Investigative Reporter, and Mike Siconolfi, Senior Editor, both with The Wall Street Journal (WSJ), took home the prestigious National Institute for Health Care Management (NIHCM) Foundation Journalism Award on Monday, May 2, for their work covering Theranos, Inc.
This is the third time this year Carreyrou has won the award in the General Circulation Print Journalism category for his work covering Theranos, the embattled clinical laboratory company in Palo Alto, Calif., owned by CEO Elizabeth Holmes.
HDL also got approval to question executives from UnitedHealthcare in court over unpaid claims, its third dispute with a health insurance company
Following a string of major setbacks, Health Diagnostic Laboratory (HDL) of Richmond, Virginia, put itself up for sale last week. This action comes after HDL’s announcement in April that it would pay more than $100 million to settle charges with federal investigators that it violated the False Claims Act. Then, early last month, the clinical laboratory company filed for bankruptcy protection.
On Tuesday, July 14, U.S. Bankruptcy Court Judge Kevin R. Huennekens approved HDL’s request to put itself up for sale through a court-monitored auction, the Richmond Times-Dispatch reported. No potential buyer has been named, but the clinical laboratory company has businesses that are interested in acquiring HDL, the Times-Dispatch added. (more…)
According to the DOJ, the labs violated the Anti-Kickback Statute by paying physicians in exchange for patient referrals, in addition to billing federal health care programs for medically unnecessary testing. Pathologists, medical laboratory scientists, and clinical laboratory directors have watched this case closely since it became public knowledge last fall.
Other Clinical Laboratories and Lab Executives Face Federal Lawsuits(more…)
