New Point of Care Test for Anemia That Patients Can Administer Themselves Has Potential to Impact Pathology Groups and Clinical Laboratories
Developed by researchers at Emory University, Children’s Healthcare of Atlanta, and the Georgia Institute of Technology, the anemia test device is awaiting clearance by the FDA
New diagnostic technology may shift some hemoglobin testing for anemia out of clinical laboratories and into near-patient settings. It may also be possible to use this new diagnostic device for patient self-testing.
The developers describe this as a new, easy, inexpensive point-of-care test (POCT) that detects anemia. The device may be available as early as 2016. It is possible for the test to be used in situations where resources are low and illiteracy is high.
The new medical laboratory test is called AnemoCheck and was developed by scientists and students at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology in Atlanta. (more…)
Mobile Stroke Unit (MSU) Brings the Laboratory to the Patient at the Point of Care
Clinical laboratories will increasingly provide emergency diagnostic services through mobile-unit near-patient testing
In an innovation designed to bring the laboratory to the patient, use of a mobile stroke unit (MSU) shortened the time to treatment decision for acute stroke patients. MSUs equipped with imaging systems and medical laboratory point-of-care testing proved capable of providing early diagnosis and intervention.
Pathologists and clinical laboratory managers will immediately recognize the implications of these findings. This study demonstrates how clinicians are taking steps to move clinical laboratory testing out of the traditional central/core laboratory and bring it closer to the patient specifically to reduce the time-to-answer for certain medical conditions, like acute stroke.
One conclusion from this clinical study is that use of a mobile stroke unit offers a potential solution to the medical problem of stroke patients arriving at the hospital too late for treatment, wrote researchers in a study published in the medical journal The Lancet.
Companion Direct Point of Care System Helps Doctors Collect Payment Quickly
With more and more consumers participating in high-deductible health plans, health savings accounts, and other forms of consumer-directed health plans, physicians and laboratories have to collect substantially more money from their patients. Collecting from patients while they are still in the physician’s office is the ideal situation, but must patients don’t know what their copayment, deductible, or out-of-pocket is for any given service. In many cases, that means that the physician must bill the insurer, wait weeks for a settlement, and then bill the patient for the balance. Patients are somewhat unlikely to pay a bill for services rendered in the distant past.
To help with the problem of in-office collection, Companion Technologies has created a card reader that accepts patients’ credit, debit, or insurance cards called Companion Direct POC. These small machines feature a keypad, a screen, and a printer that prints a patient receipt. The process works in 4 quick steps:
1. Run healthcare card through Companion Direct POC healthcare card reader and enter patient-specific information
2. Patient information sent to appropriate payer
3. Plan information and eligibility sent back in seconds
4. Print receipt and eligibility information directly from card reader
The systems are inexpensive, running about $20 per month plus a 20-cent per transaction fee. For this nominal fee, doctors can insure that a patient knows what s/he owes before s/he leaves the office.
On January 9, 2007, Companion Technologies was purchased from BlueCross BlueShield of South Carolina and sold to The Thurston Group and ABRY Partners. Now that Companion Technologies has more financing than BlueCross BlueShield of South Carolina was able to provide this small part of its operations, Dark Daily predicts that Companion Technologies will expand its promotion and implementation of real-time eligibility verification systems across the country at a rapid pace.
Laboratories can expect to be effected in a number of ways by the spread of real-time eligibility verification and real-time claims settlement. First, patients will become accustomed to eligibility verification/claims settlement services from physicians offices and will expect to see them in laboratories, as well. This means laboratories must be prepared to deal with patients on a cash basis, accepting cash, credit cards, and health debit cards. Second, laboratories and pathology groups should enjoy a better collection ratio for patient-billed services because of the real-time billing. Aspiring laboratories will make proactive responses to this trend and see it as an opportunity to create a competitive advantage, keep existing clients, and grab more market share.
Related Articles:
Thurston Group and ABRY Partners Purchase Companion Technologies Corporation
Payers Begin Speeding Up Payment to Physicians The Dark Report, November 2005
New Lead Test Technology Moves Diagnostic Testing Closer to Point of Care
On September 18, Magellan Biosciences announced that the FDA had granted a CLIA waiver for its new LeadCare® II blood-lead testing system, developed and marketed by the company’s subsidiary, ESA Biosciences. This device is now cleared to be used in non-laboratory settings, such as schools and mobile lead testing vans. The device is a key element of Magellan’s strategy to expand its offerings into the global point-of-care clinical-diagnostic market.
Any CLIA waver for a test is significant because it implies that the diagnostic technology will allow any operator to perform the test without special training or advanced certification – and get accurate, reliable, and reproducible results. Magellan’s President and CEO, Robert J. Rosenthal, says that Magellan’s plans are to use the LeadCare II platform to develop additional point-of-care tests.
DARK Daily suggests that existing laboratories take note of this news item for a number of important reasons. First, it is becoming cheaper, simpler, and faster to perform the latest generations of diagnostic tests. In the case of LeadCare II, the instrument costs $2,200 and each test kit costs $7. It uses a capillary or venous blood sample and EDTA or heparin is the anticoagulant. Two drops of blood, about 50 µl, are mixed with the reagent, transferred to a sensor strip, and a reliable answer is produced in three minutes. This allows the patient to wait in case a second sample is needed for further testing.
Second, the CLIA waiver granted for LeadCare II shows how biotech companies are investing heavily to create new technology and instrument systems that can be used outside a core laboratory to perform testing at patient’s bedside or in the physician’s office.
Third, the potential market for the LeadCare II test is large. Estimates are that one out of four children under six live in a home that has significant lead contamination. Detecting children with lead poisoning is the type of public health issue that attracts wide support and ample funding. Those are key reasons why ESA Biosciences developed this particular test.
DARK Daily predicts that much of the new diagnostic technology soon to hit the market will make it simple and reliable to perform certain diagnostic tests outside the core laboratory. In the case of the LeadCare II system, the instrument is affordable, the test kit relatively cheap, a finger stick specimen is all that is needed, and the results are provided in just three minutes. As more testing can be done in near-patient settings, the test mix in core laboratories is likely to shift away from routine testing and toward more complex reference and esoteric testing. Laboratories will have to adjust their focus so that these tests are viewed as their primary source of revenue. As point of care tests become more popular, laboratories may also want to play the “If I can’t beat ’em, I’ll join ’em” game and develop mobile units to administer point-of-care tests.
Press Release:
Magellan Biosciences Subsidiary Receives CLIA Waiver from FDA for LeadCare II
