Physician-Owned In-Office Molecular PCR Lab Program

Having an In-office PCR Lab Program's leads to improved outcomes for your patients. 

A recent Urology study found a 13.7% reduction in hospital admissions and/or ED utilization associated with the use of the M-PCR/P-AST assay compared with the use of a traditional standard urine culture (3.27% vs. 3.79%; p = 0.003).

Molecular tests are becoming more routine as diagnostic tools - covered by Medicare and most commercial insurers. In certain specialties and populations, molecular diagnostics are positioned to become a standard screening test. View White Paper

Long turnaround times can lead to further spread of communicable diseases and hinder effective contact tracing, ultimately posing health risks and increasing costs as outbreaks are not contained. 

KEEP COMPLIANT with CDC’s Antibiotic Stewardship Program, aimed at reducing unnecessary hospital readmissions and infections.

By integrating a physician-owned laboratory (POL) into your practice, your medical practice will elevate with robust services, improved treatment capabilities, and monthly revenue.

Often the large lab facilities are not just billing the insurance carrier, they also send patients to collections. The Integration of this system will grant you all-inclusive billing privileges or the option to outsource billing and the control of your patient’s financial outcome when PCR testing is utilized. 

Enrollment is simple.

Your dedicated account representative will qualify your practice for volume and billing matrix minimums.  We can provide a customized pro forma for your practice to utilize in your due diligence process and introduce you and your decision-makers to our experienced PCR Lab team via online conference for presentation and Q&A.

We would be setting up a high complexity lab (CLIA/COLA) -- either expanding your existing lab operations or starting from scratch.  Our experienced PhD Lab Consultant will help you to select the right space and design your lab area.  We can help you source and even help outsource the management of the required staff (Lab Director and Lab Technician) if you don't already have them in your organization. 

Full validation studies are completed onsite by our licensed PCR experts who will train your staff and maintain ongoing compliance of your lab. 

We offer customized program options to either own or lease-to-own equipment with 60-day deferred payment schedule, which can help with cash flow while your reimbursements are being collected.   

For qualified practices who merely meet the minimum test volume return on investment should be the first month.

After an agreement is signed, you can be up and running tests in 30-60 days.

Identifying the right pathogen is the crucial step in developing an appropriate treatment plan for an infection. The gold standard has been traditional culture and sensitivity. Now providers have an additional diagnostic test available – molecular testing. 

Traditional culture method is all about growing what's there, slowly but surely and observing phenotypic characters like shape, size, staining property, reactions in biochemical tests etc. It often involves a lot of process of trial and error, ruling out species after species until you have only one option left using observable characteristics. 

The major advantage of Real-Time PCR over traditional culture method is the ability to obtain accurate results in a very short time.

Traditional methods for diagnosing infection have relied largely on clinical microbiology laboratories selecting, isolating and then identifying pathogenic

organisms via culture. This can be very time consuming. For some fastidious or slow-growing organisms, the delay to de nitive microbiological

diagnosis can stretch to weeks, while some organisms cannot be cultured at all. Other drawbacks with culture methods include problems with

sensitivity, cost (resource intensive) and potential safety concerns with pathogenic organisms. 

PCR can precisely analyze the genetic material of pathogens, provide a more de nitive diagnosis than POC antigen assays, and can be done within 1-hour (In-Office) turn-around.

Traditional culture and sensitivity testing has been carried out since in a very similar manner to the techniques developed by Robert Koch in the late

1800s. This led to the development of the science of infectious disease, where a microbe caused a given disease. Although this was a breakthrough for identification and treatment of infectious disease, culturing worked only for a fraction of microbes.

Testing for these microbes took a few days for fast growing bacteria and up to a few weeks for the slower growing organisms. The advent of new sequencing technologies, with techniques such as PCR (polymerase chain

reaction) and microarrays has reduced analytical processing time to a matter of hours. The newly developed technologies have arrived at a time when antibiotic resistance has become a serious problem for today’s clinicians.

Infectious disease testing using Real-Time PCR and other sequencing methods will continue as a cutting-edge technology for developing primers based on known resistance genes. As a result, traditional cultures and sensitivity is not as effective as Real-Time PCR and other genetic based assays in identification of the resistant strains of organisms and how to best treat them.