KSL and COVID-19
Since its inception, KSL has been engaged in development and regulatory clearance of biomarker detection systems.
These have application to COVID-19.
KSL Biomedical has been engaged with the COVID-19 outbreak since January, 2020. Our R&D team has worked closely with public health and biotech industry partners in China, particularly in Guangdong Province, where the highest per capita testing has been achieved outside S. Korea.(1)
Recognizing the need for inexpensive, scalable, effective screening for COVID-19 in China, public health has moved to a diagnostic model incorporating antibody testing.(2)
KSL CLIA Antibody Assays
We have integrated COVID-19/SARS-COV-2/2019 nCov antibody markers with other biomarkers to assess severity into a COVID-19 antibody panel on a high-throughput chemiluminescence immunoassay (CLIA) instrument platform. A single system is capable of processing thousands of outputs per day at a fraction of the cost of PCR or NGS diagnostics with greater than 98% correlation and prognostic biomarkers that may aid physicians in triaging positive patients. Specimens utilized are standard sera. This does not require specialized collection materials and methods, as do PCR and NGS, and phlebotomy is a much safer method of collection than mucosal swabs which do not allow for N95 mask personal protective equipment (PPE).
As opposed to KSL CLIA solutions, current US diagnostic applications are expensive, with cost per test in the hundreds to thousands of dollars, not scalable, with molecular methodologies capable of producing a small fraction of tests per hour, and do not offer any prognostic information.
In partnership with industry partners, KSL has also aided in development and distribution of other diagnostic / prognostic applications, including:
Molecular diagnostics (PCR):
AmoyDx (China) Novel Coronavirus (2019-nCoV) Detection Kit
Point of Care (POCT) antibody assays:
SARS-CoV-2 IgG/IgM POCT lateral flow rapid test
Severe Respiratory Distress (SRD) cytokine panel
KSL also offers capacity for diagnostic testing through Kaleida Health laboratories and its own CLIA, NYSDOH, CAP licensed/certified labs (KSL Diagnostics, Beutner Laboratories). These laboratories have current licensing to perform a full range of molecular, clinical chemistry and immunoassay methodologies and KSL regulatory specialists are perhaps the most experienced international team to obtain international approval for IVD devices in this class.
These diagnostic applications are ready for market. With suitable US COVID-19 genetic and serological validation sets the assays are ready to be introduced through CLIA laboratories. Our regulatory team is highly qualified to complete any Emergency Use Only (EUA) submissions as well as 510k or PMA submissions for US FDA clearance. Furthermore, the base technologies have broad application beyond COVID-19. The assays and instrumentation provide a solid platform for other proprietary KSL technologies in development for diagnosis of immunological conditions.
There are some significant obstacles, however. The most immediate is transportation. KSL has been working to deliver novel diagnostics, developed in the US, in China. Almost half of KSL operations are based in China, including our CLIA instrument vendor. Because of the COVID-19 outbreak, it is prohibitively expensive or impossible to deliver the CLIA instruments by air from China to the US and there are significant tariffs associated. The next obstacle is capital. The CLIA instruments are expensive and, while the 5-10 systems currently assembled and available in our facilities in China are capable of screening Upstate New York cases, national scale-up will require STAT assembly of numerous systems at ~$50k per system. Finally, KSL and affiliated laboratories will require suitable COVID-19 genetic and serological specimen sets for verification, validation and regulatory clearance in order to comply with FDA and state department of health requirements.
If these obstacles can be overcome, testing could be introduced withing 14 days on an EUA basis and FDA IVD clearance could be achieved within 5 months if FDA breakthrough designation is utilized.
Our team has experienced the outbreak directly in China and now in the US and we are highly motivated to make an impact fighting COVID-19 here. We hope to find effective partners at home to meet these challenges.
2. Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional 7th Edition)